consensus evidence-based clinical practice guidelines for
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Archives of Osteoporosis (2021) 16:176 https://doi.org/10.1007/s11657-021-01035-z
ORIGINAL ARTICLE
Consensus evidence‑based clinical practice guidelines for the diagnosis and treat‑to‑target management of osteoporosis in Africa: an initiative by the African Society of Bone Health and Metabolic Bone Diseases
Y El Miedany1,2 · Farhanah Paruk3 · Asgar Kalla4 · A. Adebajo5 · Maha El Gaafary6 · Abdellah El Maghraoui7 · Madeleine Ngandeu8 · Dzifa Dey9 · Naglaa Gadallah10 · Mohamed Elwy10 · Farzana Moosajee11 · Mohammed Hassan Abu‑Zaid12 · Salwa Galal10 · Soussen Miladi13 · Waleed Hassan14 · Abubaker Fadlelmola15 · Sally Saber10
Received: 25 August 2021 / Accepted: 1 November 2021 © International Osteoporosis Foundation and National Osteoporosis Foundation 2021
AbstractSummary The objective of this consensus statement is to inform the clinical practice communities, research centres and policymakers across Africa of the results of the recommendations for osteoporosis prevention, diagnosis and management. The developed guideline provides state-of-the-art information and presents the conclusions and recommendations of the consensus panel regarding these issues.Purpose To reach an African expert consensus on a treat-to-target strategy, based on current evidence for best practice, for the management of osteoporosis and prevention of fractures.Method A 3-round Delphi process was conducted with 17 osteoporosis experts from different African countries. All rounds were conducted online. In round 1, experts reviewed a list of 21 key clinical questions. In rounds 2 and 3, they rated the statements stratified under each domain for its fit (on a scale of 1–9). After each round, statements were retired, modified or added in view of the experts’ suggestions and the percent agreement was calculated. Statements receiving rates of 7–9 by more than 75% of experts’ votes were considered as achieving consensus.Results The developed guidelines adopted a fracture risk-centric approach. Results of round 1 revealed that of the 21 pro-posed domains, 10 were accepted whereas 11 were amended. In round 2, 32 statements were presented: 2 statements were retired for similarity, 9 statements reached consensus, whereas modifications were suggested for 21 statements. After the 3rd round of rating, the experts came to consensus on the 32 statements. Frequency of high-rate recommendation ranged from 83.33 to 100%. The response rate of the experts was 100%. An algorithm for the osteoporosis management osteoporosis was suggested.Conclusion This study is an important step in setting up a standardised osteoporosis service across the continent. Building a single model that can be applied in standard practice across Africa will enable the clinicians to face the key challenges of managing osteoporosis; furthermore, it highlights the unmet needs for the policymakers responsible for providing bone health care together with and positive outcomes of patients’ care.
Keywords Osteoporosis · Guidelines · Africa · Bisphosphonates · Denosumab · Parathyroid hormone · Romosozumab · FRAX · Falls · African osteoporosis guidelines
Introduction
Osteoporosis is a public health epidemic that has negative impacts on health outcomes together with an enormous eco-nomic burden. The clinical relevance of osteoporosis lies in its associated fragility fractures, especially hip fractures,
* Y El Miedany [email protected]
Extended author information available on the last page of the article
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and usually it is a silent disease until such an event occurs [1]. Worldwide, osteoporosis causes more than 9 million fractures a year, meaning that there is a fragility fracture every 3 s [2]. In the Western World, it is estimated that about 1 in 3 women and 1 in 5 men above the age of 50 years old will sustain a fracture during their remaining lifetime [3]. After the age of 50 years, most sites of fracture can be considered characteristic locations of osteoporosis. Hip and vertebral fractures are the most common and serious osteo-porotic fractures. Other fragility fractures, particularly in women, such as those of the humerus, forearm, ribs, pelvis and tibia (but not including ankle fractures), after the age of 50 years, have been reported to be associated with low bone mineral density (BMD) [4]. The direct annual cost of treat-ing osteoporotic fractures of people on average is reported to be between 5000 and 6500 billion US Dollars in Canada, Europe and the USA alone, not considering indirect costs such as disability and loss of productivity [5]. Therefore, prevention of this disease can significantly reduce the mor-bidity, mortality and costs incurred by the health system.
Across Africa, the issue of bone health continues to be a major challenge. Osteoporosis has been overlooked as a health care priority in Africa, particularly in the sub-Saharan region [6]. This has been linked to several reasons. Firstly, health authorities have been overwhelmed by the burden of communicable diseases such as tuberculosis and human immunodeficiency virus (HIV) [7]. Secondly, tools to assess the BMD and consequently diagnose osteoporosis such as dual X-ray absorptiometry (DXA) are not widely available, hindering early diagnosis and treatment of the disease. Fur-thermore, concerns regarding inadequate calcium intake dur-ing adolescent years, low body mass index, prolonged dura-tion of lactation amongst women during childbearing years, low levels of vitamin D and physical inactivity amongst Africans are all risk factors for osteoporosis [8].
On another front, the demographic changes taking place in Africa have fuelled both the diagnostic and therapeutic osteoporosis inertia in Africa. Census reports showed that both the total population size and life expectancy in Africa have increased significantly in the last two decades. An overview of demographic ageing in Africa published by the United Nations [9] found that Africa will have the fastest growth rate of older adults compared to any other region in the world. Between 2020 and 2050, the older African population is projected to triple from 74.4 million to 235.1 million and will outpace that of any other region of the world [10]. This has been supported by the new Census report on ageing trends in Africa [11] which revealed that between 2017 and 2050, 50% of the world’s population is expected to be in 9 countries (India, Nigeria, Democratic Republic of the Congo, Pakistan, Ethiopia, United Republic of Tanzania, United States of America (USA), Uganda and Indonesia), i.e. 5 of them are African nations.
African older adults play critical economic, family and community roles. Studies show that majority of the adults aged 60 to 64 years and around half of those aged 65 years and older in Africa remain in the labour force. Many older Africans, particularly women, contribute substan-tial amounts to providing unpaid home and care work [9]. Therefore, caring for this sector of the population become a priori. So far, there have not been any guidelines or treat-ment recommendations published for the management of osteoporosis in Africa. This guideline has been developed as an initiative by the African Society of Bone Health and Metabolic Diseases (ASBoM) with the intention of reduc-ing the risk of osteoporosis-related fractures and thereby maintaining the quality of life for African people living with osteoporosis. It has been based on the outcomes of systematic reviews carried out in Africa on epidemiology of osteoporotic fractures as well as risk factors of osteo-porosis in Africa. The objective is to provide a consensus, evidence-based information about the diagnosis, evaluation and treat-to-target management of osteoporosis in both men and postmenopausal women for the African health care pro-fessionals managing osteoporosis patients in general, regu-latory bodies, health-related organizations and interested patients’ groups/laypersons. Although framed for Africa, it is hoped that these guidelines will be valuable for bone health specialists across the globe.
Methods
A qualitative synthesis of scientific evidence and consensus, based on clinical experience and existing scientific evidence, was used to formulate the study design and the following procedures. This work conforms to the preferred reporting items for systematic reviews and meta-analyses guidelines for reporting systematic reviews [12].
Study teams
Core team Core team was composed of four experts in bone metabolism who were selected by the African Society of Bone Health and Metabolic Bone Diseases. Their task was to supervise, coordinate and assist with developing the scope of the project and initial Patient/Population, Intervention, Comparison, and Outcomes (PICO) questions. The core team prespecified outcomes as critical for each PICO ques-tion for the systematic literature review. The team also nomi-nated the expert panel and drafting the manuscript.
Literature review team
Led by an experienced literature review consultant and based on specific research questions identified to focus on
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the treat-to-Target management of osteoporosis, the litera-ture review was conducted with the assistance of an expert in methodology. The team completed the literature search (the PubMed/ MEDLINE, EMBASE and Cochrane data-bases), data abstraction and the quality of evidence rating [13]. Following the revision, each of the experts respon-sible for the literature review provided recommendations regarding each section based on evidence, when that was available or on their own experience. The level of evidence was determined for each section using the Oxford Centre for Evidence-based Medicine (CEBM) system (Table 1) [14].
Data sources and search strategies
The PICO questions (Table 2) were used to conduct the liter-ature search in PubMed, Embase and Cochrane Library data-bases. Literature search strategies were carried out to locate randomised clinical trials evaluating the efficacy of osteopo-rosis quality improvement strategies published from 1990 to April 2021. The language was limited to English and French for pragmatic reasons. The search strategies were designed to be broad to have high sensitivity for identifying relevant literature. We used the following Medical Subject Headings (MeSH) terms: osteoporosis, postmenopausal osteoporosis, osteop?nia, T-score, bone resorption, fracture, osteoporosis
Table 1 Levels of evidence and grades of recommendation
Level of evidence
1 Systematic review of all relevant randomised clinical trials or n-of-1 trials2 Randomised trial or observational study with dramatic effect3 Non-randomised controlled cohort/follow-up study (observational)4 Case series, case–control study or historically controlled study5 Mechanism-based reasoning (expert opinion, based on physiology, animal or
laboratory studies)Grades of recommendationA Consistent level 1 studiesB Consistent level 2 or 3 studies, or extrapolations from level 1 studiesC Level 4 studies, or extrapolations from level 2 or 3 studiesD Level 5 evidence or troubling, inconsistent or inconclusive studies of any level
Table 2 Key questions used to develop the guideline 1 Who are the targeted people for these guidelines?
2 What are the fracture risk factors?3 How to assess for fracture risk and what are the cut-off points?4 How is osteoporosis diagnosed?5 When osteoporosis is diagnosed, what is the approach for an appropriate evaluation?6 What are the fundamental non-pharmacologic measures recommended for optimum bone health?7 Who is in need for pharmacologic therapy?8 What medication should be used to treat osteoporosis?9 What is the approach for osteoporosis pharmacological management?10 What are the recommendations for calcium and vitamin D supplement therapy?11 How is treatment monitored?12 Treat-to-target: What are the targets that reflect successful osteoporosis management?13 How long should patients be treated?14 Is there an opportunity for a drug holiday?15 What is the role of concomitant use of therapeutic agents?16 What is the role of sequential use of therapeutic agents?17 What is the role of vertebral augmentation for compression fractures?18 What is the importance of falls assessment?19 How important is the implementation of fracture liaison service (FLS)?20 How osteoporosis in men is managed?21 How to manage the patients on glucocorticoids therapy?22 What is the advice given to osteoporosis patients during the COVID-19 pandemic?
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treatment, osteoporosis management, calcium, vitamin D, alendronate, risedronate, etidronate, ibandronate, zoledronic acid, raloxifene, calcitonin, teriparatide, hormone replace-ment therapy, teriparatide, abaloparatide, romosozumab, denosumab, glucocorticoids, treatment induced osteopo-rosis, hip protectors, meta-analysis, systematic reviews, randomized controlled trials, bone density, FRAX, fracture liaison service, falls, Covid-19, treat to target. Keywords used were dependent on the PICO elements used in differ-ent combinations. Literature searches on 23rd April 2021 for PubMed and Cochrane Library databases, and on 28th April 2021 for Embase. Duplicate screening of literature search results was performed electronically. Additional rel-evant studies were retrieved by reviewing the reference lists of studies identified with the database search strategies that met the inclusion criteria.
Study selection
We selected relevant studies by applying inclusion and exclusion criteria to the literature retrieved with the search strategies.
Inclusion criteria
Articles included were systematic reviews, randomised controlled trials (RCTs), uncontrolled trials, observational studies including cohort, case–control and cross-sectional studies, or those where economic evaluation was made.
Exclusion criteria
Editorials, commentaries, conference abstracts and non-evidence-based narrative/personal reviews were excluded.
Expert panel Given the fact that the developed guideline will be adopted across the continent of Africa, it was vital that the participating expert panel involved in developing the guideline would include experts from all the African conti-nent regions (Central, North, West, East and South Africa). Expert panel members were appointed by the core team. The core leadership team nominated 17 participants. The criteria for their selection included existence of professional knowl-edge and experience (at least 8 years of experience) in the field of bone health, management of osteoporosis and active participation in scientific research on bone health disorders. The expert panel assisted with developing the scope of the project and refining the PICO questions. PICO questions were drafted into recommendation statements and were sent to the expert panel with the evidence report who voted on the recommendations.
Key questions used to develop the guideline
This guideline was based on a series of structured key questions that define the targeted population, frac-ture assessment, diagnostic tools, investigation, the comparison(s) utilised and the outcomes used to measure efficacy, effectiveness or risk. The evidence to answer the clinical questions was collected according to the follow-ing steps: formulation of clinical questions, structuring of questions, search for evidence, critical evaluation and selection of evidence, presentation of results and recom-mendations. These questions, shown in Table 2, formed the basis of the systematic literature search and conse-quently the clinical care standards.
Developing the standards of clinical care framework
Based on the answers to the structured key questions and the literature review, a structured template was devel-oped to facilitate standardised identification of guideline components. For each guideline component, the format in which the recommendations/information was provided and extracted has been identified.
Delphi process
The Delphi technique is a structured method widely used to gather important information on a specific topic. It relies on the key assumption that forecasts from a group are generally more accurate than those from individuals. Therefore, the aim of the Delphi method is to construct consensus forecasts from a group of experts in a structured iterative manner. Its methodology is based on a series of questionnaires or ‘rounds’ addressed to experts. The key features of this method are the anonymity of participants and controlled feedback [15].
Delphi rounds
This was based on a three-stage on-line survey.
– The first round: the participants were asked to consider the items identified by the systematic literature review, to suggest new items that might have been missed and to clarify items that might be unclear.
– The second round was based on the results of the first round, and participants were asked to rate each item from 1 (not appropriate) to 9 (completely appropriate) and give their comments.
– The third round, the participants reviewed the responses to each item obtained in the second round, after amend-
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ments wherever appropriate, and to rate the items after alterations (from 1 to 9)
Voting process
Live online-delivered voting was carried out in repeated rounds that were strictly time limited. All members of the task force were invited to participate and pre-informed of the time of opening and closure of each round of votes. Unique access links were sent out, and anonymous votes were gath-ered and processed. Comments on re-phrasing, potential ambiguity and unidentified overlaps were gathered regard-ing each statement at the same time in the voting process. Only the members of the task force had the right to vote on the statements.
Rating
Each statement is rated between 1 and 9 where 1 being ‘complete disagreement’ and 9 being ‘complete agreement’. Generally, 1–3, 4–6 and 7–9 represent disagreement, uncer-tainty and agreement, respectively. The ‘uncertainty’ vote represents ‘inconvenience about the accuracy of the recom-mendation’. There was no requirement to vote on all state-ments, and the members were encouraged to abstain if they felt that a statement fell outside their area of expertise. All statements were allowed for the entry of comments, which were reviewed by the scientific committee after each round of voting. The same scenario was adopted in each round of votes; the members were further urged to leave comments wherever they vote a disagreement. This enabled the panel to identify an instance of misinterpretation of statement and invalidate the vote on that statement.
Definition of consensus
Definition of consensus was established before data analy-ses. It was determined that consensus would be achieved if at least 75% of participants reached agreement (score 7–9) or disagreement (score 1–3) [15–18]. A statement was retired if it had a mean vote below 3 or a ‘low’ level of agreement. Statements whose rate come in the uncertainty score (4–6) were revised in view of the comments. The levels of agree-ment on each statement of recommendation were defined as ‘high’ if after the second round of votes, all votes on a state-ment fell into the agreement bracket (7–9) [18].
Data management and analysis
Survey data were combined as a total sample, included 17 individual responses, were analysed using SPSS Statistical Software (Statistical Package of Social Science, Armonk, New York), and results reported as means and standard
deviation. Analysis by geography was not possible due to the anonymity of survey responses.
Ethical aspects
This study was performed in accordance with the Helsinki Declaration. Ethics approval was deemed unnecessary. Ver-bal informed consent was required from all the participants included in the study. All the participants were kept anony-mous, in compliance with data protection regulations. The research questions, project oversight and resulting consen-sus-based practice guidelines were created by the core team and expert panel. The resulting guidelines do not reference or recommend any specific product; rather, they focus on how to assess and utilise the evidence to put a frame that is best suited for the patients’ management.
Results
Literature research and evidence selection
Evidence was obtained through literature searches and 3443 potentially relevant studies were initially identified. A total of 3339 studies were excluded for duplication (1266) or by screening of title and abstracts (2073). These are the studies which did not examine population or intervention of inter-est, did not match study design of interest or did not report outcome measures of interest. Therefore, relevant 104 stud-ies were included for full article review. In total, 78 studies were excluded as citations did not provide evidence match-ing a PICO. Therefore, 26 studies were included in this work (Fig. 1).
Expert panel characteristics
The Delphi form was sent to the expert panel (n = 17), who participated in the three rounds. Respondents were drawn from several countries covering the different geographical regions of Africa: Egypt: 8 (47%), Morocco: 1 (5.8%), South Africa: 3 (17.64%) and 1 (5.8%), from each of: Cameron, Nigeria, Ghana, Tunisia and Sudan. The participants were rheumatologists who are specialised in the management of osteoporosis with mean experience of 20.3 ± 11.24 years.
Delphi round 1
The key clinical question comprised of 22 questions. In this round, the participants were asked to rate the overall principles considered in the decision-making for treat-to-target management of patients living with osteoporosis. The response rate for round 1 was 100% (17/17). The 17 experts accepted 10 of the proposed domains, suggested
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amendments for the remaining 12. Of the suggested changes, comments were raised regarding the domain ‘who are tar-geted in this guideline’, particularly regarding definite dis-crimination of both male and female osteoporosis; hence, it was considered when formulating the statements. There was a diversity of comments whether to merge the statements on treatment duration and the drug holiday, but it was decided to keep them separate. Other comments suggested the strati-fication of osteoporosis management into pharmacological and non-pharmacological with recommendation to clarify the concomitant use of therapeutic agents and adjunctive therapy; hence, a new subheading was added. Some of the modifications consisted of minor wording changes. Table 3 shows a list of the major as well as minor osteoporosis risk factors.
Delphi round 2
Based on input from round 1, the 17 experts were pre-sented with 32 statements stratified under 22 domains. The response rate for round 2 was 100% (17/17). Of the state-ments presented, two statements were retired for similar-ity with another statement, 9 statements reached consensus (i.e. ≥ 75% of respondents strongly agreed or agreed) and
were retained, whereas modifications were suggested for 21 statements. Comments (excluding minor editing sug-gestions) were more frequent for 4 domains: osteoporosis fracture risk, non-pharmacologic measures for bone health, male osteoporosis and steroid-associated osteoporosis. The statements were revised and amended. In addition, one state-ment was suggested to be added to the daily supplementa-tion of calcium and vitamin D therapy domain and another one was added to the non-pharmacologic measures of bone health domain.
Delphi round 3
Based on input from round 2, the 17 experts were pre-sented with 32 statements stratified under 22 domains. The response rate for round 3 was 100% (17/17). The experts came to consensus on the 32 statement to retain in the treat-to-target management guideline. The core team reviewed and made minor revisions to one of the retained statements that reached consensus. Consensus was reached (i.e. ≥ 75% of respondents strongly agreed or agreed) on all the clinical standards. Frequency of high-rate recommendation (rank 7–9) ranged from 83.33 to 100%. The experts were com-fortable with the final list of the statements and with the Delphi process overall. Table 4 shows the level of evidence and grade of recommendation assigned to each statement, in accordance with the Oxford Centre for Evidence-Based Medicine (CEBM) criteria as well as mean ± standard devia-tion and level of agreement [14]. Agreement was unanimous (> 80% agreement) for the wording of the statements.
Recommendations for management of osteoporosis
At the end of round 3, a total of twenty-two domains were obtained and a consensus was reached on all the statements developed. As health care professionals need information that is clear and readily accessible as well as applicable in standard clinical practice, it was important to articulate the developed osteoporosis guideline for the day-to-day prac-tice. This is summarised in Fig. 2 which shows an algo-rithm for the treat-to-target management of postmenopausal osteoporosis.
Discussion
The prevalence of osteoporosis is increasing steadily in developing countries secondary to increased longevity, with osteoporosis and its consequent fractures are becom-ing a major public health issue [21]. Epidemiological studies showed that in sub-Saharan Africa, the prevalence of osteo-porosis was 20reported to range from 18.2 to 65.8% across a heterogenous at-risk population. Similar figures were
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N=26 ar�cles remained
Fig. 1 Flow chart for the study selection process
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reported in North Africa. The prevalence of osteoporosis in Egypt was 21.9% in men and 28.4% in women; whilst 26% of men and 53.9% of women having osteopenia [22]. The prevalence of osteoporosis in Moroccan postmenopau-sal women ranged between 21 and 31% [23, 24], which is similar to Tunisia, where 25% of postmenopausal women have osteoporosis [25], whereas the rate was slightly higher (35.8%) amongst Algerian women [26]. These rates were in concordance with the outcomes of studies evaluating the major clinical consequences of osteoporosis, i.e. fractures. A recent study investigating the incidence of hip fractures amongst Black South Africans found an age-adjusted hip fracture rate of 69.2 per 100,000 per annum and 73.1 per 100,000 per annum for women and men, respectively [27]. This evidence challenges the long-held view that osteoporo-sis-related fractures are rare in Blacks [28, 29] and highlight the importance of addressing the issue of osteoporosis in Africa.
The developed guideline agrees with the published guide-lines from individual African nations for the management of osteoporosis including Egypt [30] and South Africa [31] as well as the international guidelines [32–34]. The guide-line recommends very early intervention with osteoanabolic agents, for patients who are at very high risk of fracture. This agrees with the most recently published treatment
recommendations, which endorsed the sequential as well as switch approaches of therapy [35, 36]. It also advocated a preventive approach for osteopenia patients at moderate to high risk of fractures, which agree with the recent avail-able evidence [20]. The statements on osteoporosis manage-ment for patients with COVID-19 agree with those recently published by the National Osteoporosis Foundation [37]. This highlights the importance of having updated recom-mendations for osteoporosis management based on up-to-date evidence for best clinical practice. This guideline not only provides solutions for early identification of the cases, which will consequently help to will reduce fracture rates, but also enables health care professionals with special inter-est in bone health to face the key challenges of managing osteoporosis in Africa. The guidelines will assist the poli-cymakers responsible for providing care for populations in relation to bone health to formulate appropriate policies.
Either a BMD-centric or a fracture risk-centric approach could be adopted to identify patients for whom pharmaco-logical intervention should be considered. This guideline adopted the fracture risk-centric approach, though the BMD measurement was integrated, mainly for those with moder-ate fracture risk. This was based on the finding that DXA studies are seldomly used in Africa to assess for osteoporosis risk. This has been attributed in several cases to the lack of
Table 3 Modifiable and non-modifiable osteoporosis risk factors
RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; DMPA, depot medroxyprogesterone acetate; GnRH, gonadotropin-releasing hormone; PPIs, proton pump inhibitors; TZD, thiazolidinediones
Non-modifiable risk factors Previous fractureParental history of osteoporosisHistory of early menopause (below age of 45 years)
Modifiable risk factors Low BMI (< 20 kg/m2)SmokingLow bone mineral densityAlcohol intake
Co-existing diseases DiabetesInflammatory rheumatic diseases (RA or SLE)Inflammatory bowel disease and malabsorptionInstitutionalised patients with epilepsyHuman immunodeficiency virusPrimary hyperparathyroidism and endocrine
diseasesChronic liver diseaseNeurological diseases (including Alzheimer’s
disease, Parkinson’s disease, multiple sclerosis, stroke)
Moderate to severe chronic kidney diseaseAsthma
Drug therapy Long-term antidepressantsAntiepilepticsAromatase inhibitorsLong-term DMPAGnRH agonists (in men with prostate cancer)PPIsOral glucocorticoidsTZDs
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Tabl
e 4
Bre
akdo
wn
of st
atem
ents
of r
ecom
men
datio
ns, i
ts in
divi
dual
rank
by
expe
rt op
inio
n an
d le
vel o
f agr
eem
ent
No
Dom
ain
Stat
emen
tsLE
GoR
Mea
n ra
teSD
% o
f ag
reem
ent
Leve
l of
agre
emen
t
Who
are
targ
eted
in th
ese
guid
elin
es?
Wom
en*P
ostm
enop
ausa
l wom
en a
ged ≥
50 y
ears
(2a)
Postm
enop
ausa
l wom
en a
t hig
h ris
k of
frac
ture
s (2a
)Po
stmen
opau
sal w
omen
who
hav
e ex
perie
nced
a re
cent
frac
ture
(2a)
Wom
en w
ith se
cond
ary
caus
es o
f oste
opor
osis
(2a)
Men
with
a T
scor
e in
the
oste
open
ic ra
nge
(T sc
ore −
1 to
− 2.
5) if
they
hav
e be
en id
entifi
ed to
hav
e a
high
or v
ery
high
frac
ture
risk
(2b)
Men
:- M
en a
t the
age
of 7
0 ye
ars o
r old
er (2
a)- M
en w
hose
age
is le
ss th
an 7
0 ye
ars o
ld, a
t hig
h ris
k of
frac
ture
(2a)
- Men
Ove
r 60
year
s old
who
hav
e ex
perie
nced
a re
cent
frac
ture
(2a)
- Men
with
seco
ndar
y ca
uses
of o
steop
oros
is (2
a)- M
en w
ith a
T sc
ore
in th
e os
teop
enic
rang
e (T
scor
e − 1
to −
2.5)
if th
ey h
ave
been
iden
tified
to h
ave
a hi
gh o
r ver
y hi
gh fr
actu
re ri
sk (2
b)
2 2 2 2 2 2 2 2 2 2
A A A A B A A A A B
8.9
0.5
94.1
%H
Wha
t are
the
oste
opor
osis
fr
actu
re ri
sk fa
ctor
s?Se
e Ta
ble
32
A8.
671.
2581
.66
H
How
to a
sses
s for
frac
ture
risk
?an
dw
hat a
re th
e cu
t-off
poin
ts?
• Sc
reen
ing
for f
ract
ure
risk:
- FR
AX
, with
out B
MD
, is a
n im
porta
nt w
eb-b
ased
tool
in th
e as
sess
men
t of f
ragi
lity
frac
ture
risk
in
oste
opor
osis
and
shou
ld b
e us
ed to
scre
en th
e pa
tient
s and
stra
tify
them
acc
ordi
ng to
thei
r fra
ctur
e ris
k- C
onsi
der b
one
min
eral
den
sity
testi
ng b
ased
on
clin
ical
frac
ture
risk
pro
file
- It i
s adv
isab
le to
cal
cula
te th
e FR
AX
scor
e ac
cord
ing
to th
e va
lidat
ed n
atio
nal m
easu
res
- If n
o na
tiona
l mea
sure
s are
avai
labl
e, th
e FR
AX
can
be
calc
ulat
ed a
ccor
ding
to re
gion
al v
alid
ated
m
easu
res
- Adj
ustm
ent o
f the
con
vent
iona
l FR
AX
esti
mat
es o
f pro
babi
litie
s of h
ip fr
actu
re a
nd a
maj
or o
steo-
poro
tic fr
actu
re sh
ould
be
carr
ied
out t
o m
odul
ate
the
risk
asse
ssm
ent w
hene
ver a
ppro
pria
te- W
here
ver p
ossi
ble,
FR
AX
shou
ld b
e ad
juste
d fo
r TB
S (tr
abec
ular
bon
e sc
ore)
- Pat
ient
s sho
uld
be st
ratifi
ed a
ccor
ding
to th
eir r
isk
of fr
actu
re, l
ow, m
oder
ate,
hig
h an
d ve
ry h
igh
risk
Low
risk
incl
udes
no
prio
r hip
or s
pine
frac
ture
s, a
BM
D T
scor
e at
the
hip
and
spin
e bo
th a
bove
− 1.
0 an
d 10
-yea
r hip
frac
ture
risk
< 1%
and
10-
year
risk
of m
ajor
oste
opor
otic
frac
ture
s < 10
%M
oder
ate
risk
incl
udes
no
prio
r hip
or s
pine
frac
ture
s, a
BM
D T
-sco
re a
t the
hip
and
spin
e bo
th
betw
een
– 1
and −
2.5
or 1
0-ye
ar h
ip fr
actu
re ri
sk <
3% o
r ris
k of
maj
or o
steop
orot
ic fr
actu
res <
20%
Hig
h ris
k in
clud
es a
prio
r spi
ne o
r hip
frac
ture
, or a
BM
D T
scor
e at
the
hip
or sp
ine
of −
2.5
or b
elow
or
10-
year
hip
frac
ture
risk
> 3%
or r
isk
of m
ajor
oste
opor
otic
frac
ture
risk
> 20
%Ve
ry h
igh
frac
ture
risk
incl
udes
rece
nt fr
actu
re (e
.g. w
ithin
pre
cedi
ng 1
2 m
onth
s), f
ract
ure
whi
lst
on a
nti-o
steop
oros
is m
edic
atio
n, m
ultip
le fr
actu
res,
frac
ture
s whi
lst ta
king
dru
gs th
at a
ffect
bon
e ad
vers
ely
(e.g
. lon
g-te
rm g
luco
corti
coid
ther
apy)
, a B
MD
T-s
core
≤ −
3, h
igh
risk
of fa
lls o
r pre
vi-
ous h
istor
y of
inju
rious
falls
and
a v
ery
high
frac
ture
pro
babi
lity
(the
exam
ple
give
n is
a F
RA
X
scor
e > 30
% fo
r maj
or o
steop
orot
ic fr
actu
re a
nd >
4.6%
for h
ip fr
actu
re)
Adj
ustm
ent o
f FR
AX
10-
year
pro
babi
lity
of fr
actu
re sh
ould
be
carr
ied
out f
or a
ll pa
tient
s tak
ing
gluc
o-co
rtico
id th
erap
y. T
he in
divi
dual
pat
ient
’s ri
sk sh
ould
be
adju
sted
for t
he g
luco
corti
coid
dos
e [1
9]
1 2A A
8.9
0.5
94.1
Archives of Osteoporosis (2021) 16:176
1 3
Page 9 of 20 176
Tabl
e 4
(con
tinue
d)
No
Dom
ain
Stat
emen
tsLE
GoR
Mea
n ra
teSD
% o
f ag
reem
ent
Leve
l of
agre
emen
t
How
is o
steop
oros
is d
iagn
osed
?- B
MD
testi
ng is
the
gold
stan
dard
in d
iagn
osin
g os
teop
oros
is. T
he W
HO
reco
mm
ende
d th
e di
agno
sis
of o
steop
oros
is b
ased
on
the
T-sc
ores
at e
ither
hip
or s
pine
- The
1/3
radi
us m
ay b
e co
nsid
ered
as a
n al
tern
ate
site
whe
n th
e lu
mba
r spi
ne/h
ip is
not
eva
luab
le o
r as
an a
dditi
onal
site
in p
atie
nts w
ith p
rimar
y hy
perp
arat
hyro
idis
m:
Cut
-off
poin
ts o
f T-s
core
:- T
-sco
re ≥
− 1
indi
cate
s nor
mal
BM
D- T
-sco
re b
etw
een −
1 an
d − 2.
5 in
dica
tes o
steop
enia
or l
ow b
one
mas
s- T
-sco
re ≤
− 2.
5 in
dica
tes o
steop
oros
is- T
-sco
re ≤
− 2.
5 ac
com
pani
ed b
y a
frag
ility
frac
ture
den
otes
seve
re o
steop
oros
is- W
hen
the
initi
al d
iagn
osis
of o
steop
oros
is is
mad
e ba
sed
on a
T-s
core
of −
2.5
or b
elow
, the
dia
gnos
is
of o
steop
oros
is re
mai
ns e
ven
whe
n a
subs
eque
nt D
XA
ass
essm
ent s
how
s a T
-sco
re b
ette
r tha
n − 2.
5 (g
rade
2a)
- Oste
opor
osis
can
be
diag
nose
d in
pat
ient
s with
a T
-sco
re b
etw
een −
1.0
and −
2.5
and
incr
ease
d fr
actu
re ri
sk u
sing
FR
AX
® o
r sus
tain
a fr
agili
ty fr
actu
re- T
he d
iagn
ostic
DX
A c
riter
ia e
stab
lishe
d by
the
WH
O a
pply
onl
y to
the
axia
l mea
sure
men
ts (i
.e. l
um-
bar s
pine
, fem
oral
nec
k an
d to
tal h
ip) a
nd d
istal
1/3
of t
he ra
dius
. Thu
s, ot
her t
echn
olog
ies s
houl
d no
t be
used
to d
iagn
ose
oste
opor
osis
but
may
be
used
to a
sses
s fra
ctur
e ris
k
2A
8.58
0.82
100
H
Whe
n os
teop
oros
is is
dia
g-no
sed,
wha
t is t
he a
ppro
ach
for a
n ap
prop
riate
eva
luat
ion?
Hei
ght s
houl
d be
mea
sure
d ev
ery
1–2
year
s in
adul
ts ≥
50 y
ears
of a
ge- A
sses
s for
cau
ses o
f sec
onda
ry o
steop
oros
isB
ioch
emic
al te
sts:
Bon
e pr
ofile
: cal
cium
, pho
spho
rous
, alk
alin
e ph
osph
atas
e, e
GFR
, cre
atin
ine
Whe
neve
r ind
icat
ed:
- 25-
hydr
oxyv
itam
in D
: sym
ptom
s of v
itam
in D
defi
cien
cy- P
arat
hyro
id h
orm
one
(PTH
): pe
rsist
ent h
yper
calc
aem
ia- S
erum
testo
stero
ne, L
H, F
SH a
nd S
HB
G, P
SA (m
en)
- 24-
h ur
inar
y co
rtiso
l/dex
amet
haso
ne su
ppre
ssio
n te
st- E
ndom
ysia
l and
/or t
issu
e tra
nsgl
utam
inas
e an
tibod
ies (
coel
iac
dise
ase)
Rad
iolo
gica
l:A
sses
smen
t for
pre
senc
e of
ver
tebr
al fr
actu
re(s
) eith
er b
y:- X
-ray
,- D
XA
-bas
ed V
erte
bral
frac
ture
ass
essm
ent (
VFA
) or
- Oth
er ra
diol
ogic
al in
vesti
gatio
ns su
ch a
s CT
or M
RI a
re o
f val
ue p
artic
ular
ly fo
r ver
tebr
al fr
actu
re
asse
ssm
ent
2A
8.83
110
0H
Wha
t are
the
fund
amen
tal n
on-
phar
mac
olog
ic m
easu
res f
or
bone
hea
lth?
- Pat
ient
edu
catio
n/gr
oup
ther
apy
can
be o
f val
ue in
oste
opor
osis
man
agem
ent
- Sha
red
deci
sion
-mak
ing
tool
s are
a g
ood
and
pref
erab
le o
ptio
n to
ens
ure
patie
nt a
dher
ence
to th
erap
y an
d po
sitiv
e tre
atm
ent o
utco
mes
- Life
style
mea
sure
s suc
h as
incr
easi
ng le
vels
of p
hysi
cal a
ctiv
ity a
nd p
erfo
rm w
eigh
t-bea
ring
exer
cise
, sto
p sm
okin
g an
d al
coho
l int
ake,
car
e fo
r oth
er re
leva
nt c
omor
bidi
ties a
s ren
al o
r isc
haem
ic c
ardi
o-va
scul
ar d
isea
ses a
re v
ery
impo
rtant
in im
prov
ing
bone
hea
lth- E
xerc
ise
is im
porta
nt fo
r man
agin
g os
teop
oros
is, w
ith a
ppro
pria
te sa
fety
pre
caut
ions
- Cou
nsel
pat
ient
s to
limit
alco
hol i
ntak
e to
no
mor
e th
an 2
uni
ts p
er d
ay- P
re-tr
eatm
ent d
enta
l che
ck-u
p is
adv
ised
par
ticul
arly
in th
e pr
esen
ce o
f ris
k fa
ctor
s suc
h as
dia
bete
s m
ellit
us o
r hist
ory
of p
oor d
enta
l hea
lth st
atus
- Pre
vent
ion
of fa
lls a
nd c
onsi
der h
ip p
rote
ctor
s
2A
8.9
0.14
100
H
Archives of Osteoporosis (2021) 16:176
1 3
176 Page 10 of 20
Tabl
e 4
(con
tinue
d)
No
Dom
ain
Stat
emen
tsLE
GoR
Mea
n ra
teSD
% o
f ag
reem
ent
Leve
l of
agre
emen
t
Who
nee
ds p
harm
acol
ogic
th
erap
y?- P
atie
nts w
ith h
igh
(10-
year
pro
babi
lity
for m
ajor
oste
opor
otic
frac
ture
is ≥
20%
or t
he 1
0-ye
ar p
roba
-bi
lity
of h
ip fr
actu
re is
≥ 3%
) or v
ery
high
(10-
year
pro
babi
lity
for m
ajor
oste
opor
osis
frac
ture
> 30
%,
hip
frac
ture
> 4.
5%) f
ract
ure
risk
as a
sses
sed
by F
RA
X- P
atie
nts w
ith T
-sco
re o
f − 2.
5 or
low
er in
the
spin
e, fe
mor
al n
eck
or to
tal h
ip- P
atie
nts w
ith T
-sco
re b
etw
een −
1.0
and −
2.5
if th
e FR
AX
® (a
fter a
djus
tmen
t or r
ecal
cula
ted
usin
g TB
S if
avai
labl
e) 1
0-ye
ar p
roba
bilit
y fo
r maj
or o
steop
orot
ic fr
actu
re is
≥ 20
% o
r tha
t of h
ip fr
actu
re
is ≥
3%, w
here
ver a
pplic
able
usi
ng th
e co
untry
-spe
cific
thre
shol
ds- P
atie
nts w
ith im
min
ent f
ract
ure
risk
(hist
ory
of lo
w tr
aum
a fr
actu
re w
ithin
the
past
12 m
onth
s) o
r su
stai
ning
mul
tiple
frac
ture
s- P
atie
nts w
ho su
stai
n fr
actu
res w
hilst
on
oste
opor
osis
pha
rmac
olog
ical
ther
apy
- All
patie
nt w
ho a
re o
n lo
ng-te
rm th
erap
y (>
3 m
onth
s), o
r sus
tain
ing
frac
ture
s, w
hilst
on
med
icat
ion
that
may
impa
ct n
egat
ivel
y on
the
bone
hea
lth su
ch a
s lon
g-te
rm g
luco
corti
coid
s, an
drog
en d
eple
tion
ther
apy,
hor
mon
e an
tago
nist
ther
apy
- Pat
ient
s with
oste
opae
nia
(T sc
ore
from
− 1
to −
2.5)
who
hav
e m
oder
ate
risk
of fr
actu
re F
RA
X fr
ac-
ture
risk
pro
babi
lity
1–3%
at t
he h
ip a
nd 1
0–20
% a
t spi
ne m
ay b
e go
od c
andi
date
s for
pro
phyl
actic
zo
ledr
onic
aci
d ev
ery
18 m
onth
s for
4 in
fusi
ons [
20]
1A
8.92
0.5
100
H
Wha
t med
icat
ion
shou
ld b
e us
ed to
trea
t OP?
Ant
i-res
orpt
ives
:- B
isph
osph
onat
es: a
lend
rona
te, r
ised
rona
te a
nd z
oled
rona
te a
re a
ppro
pria
te a
s ini
tial t
hera
py fo
r mos
t os
teop
orot
ic p
atie
nts w
ith h
igh
frac
ture
risk
(gra
de 1
)- D
enos
umab
: app
ropr
iate
as i
nitia
l the
rapy
(if t
here
is c
ontra
indi
catio
n to
or i
ntol
erab
ility
to o
ral
bisp
hosp
hona
tes)
for o
steop
orot
ic p
atie
nts w
ith h
igh
frac
ture
risk
(gra
de 1
)- H
RT/ra
loxi
fene
: may
be
appr
opria
te in
itial
ther
apy
in so
me
case
s who
are
into
lera
ble
or h
ave
con-
train
dica
tions
to b
isph
osph
onat
e th
erap
yA
nabo
lics:
- Aba
lopa
ratid
e, te
ripar
atid
e- R
omos
ozum
ab c
an b
e co
nsid
ered
for p
atie
nts w
ho d
id n
ot re
spon
d po
sitiv
ely
(incr
ease
in th
e B
MD
) or
sust
ain
a fr
actu
re w
hilst
on
bisp
hosp
hona
te th
erap
y; o
r as i
nitia
l the
rapy
for p
atie
nts a
t ver
y hi
gh
frac
ture
risk
1 1 2 1 2
A A B A B
8.8
0.18
100
H
Archives of Osteoporosis (2021) 16:176
1 3
Page 11 of 20 176
Tabl
e 4
(con
tinue
d)
No
Dom
ain
Stat
emen
tsLE
GoR
Mea
n ra
teSD
% o
f ag
reem
ent
Leve
l of
agre
emen
t
Oste
opor
osis
pha
rmac
olog
ical
m
anag
emen
t:- O
ral b
isph
osph
onat
es (a
lend
rona
te, r
ised
rona
te) a
re fi
rst-l
ine
treat
men
ts in
the
maj
ority
of o
steop
oro-
sis c
ases
. Iba
ndro
nate
is n
ot re
com
men
ded
to re
duce
non
-ver
tebr
al o
r hip
frac
ture
risk
(gra
de 1
)- P
atie
nts a
ged ≥
65 y
ears
with
oste
opae
nia
(T sc
ore
from
− 1
to −
2.5
at e
ither
the
tota
l hip
or t
he
fem
oral
nec
k on
eith
er si
de) w
ho h
ave
mod
erat
e ris
k of
frac
ture
(10-
year
frac
ture
pro
babi
lity
at th
e hi
p in
the
rang
e of
1–3
% a
nd 1
0–20
% a
t the
spin
e) c
an b
e el
igib
le to
rece
ive
prop
hyla
ctic
trea
tmen
t zo
ledr
onic
aci
d 5
mg
IV e
very
18
mon
ths f
or 4
dos
es (g
rade
2b)
- In
oste
opor
otic
wom
en w
ho a
re in
tole
rant
of o
ral b
isph
osph
onat
es o
r in
who
m th
ey a
re c
ontra
indi
-ca
ted;
intra
veno
us b
isph
osph
onat
es o
r den
osum
ab p
rovi
de th
e m
ost a
ppro
pria
te a
ltern
ativ
es a
s ini
tial
ther
apy
(with
ralo
xife
ne o
r hor
mon
e re
plac
emen
t the
rapy
as a
dditi
onal
opt
ions
); ho
wev
er, t
his s
houl
d be
dec
ided
and
pre
scrib
ed b
y os
teop
oros
is sp
ecia
list (
grad
e 2a
)- O
ral a
nd in
trave
nous
bis
phos
phon
ates
are
con
train
dica
ted
in p
atie
nts w
ith h
ypoc
alca
emia
, hyp
er-
sens
itivi
ty to
bis
phos
phon
ates
and
seve
re re
nal i
mpa
irmen
t (eG
FR ≤
35 m
L/m
in fo
r ale
ndro
nate
an
d zo
ledr
onic
aci
d an
d ≤ 30
mL/
min
for o
ther
bis
phos
phon
ates
). Pr
egna
ncy
and
lact
atio
n ar
e al
so
cont
rain
dica
tions
. Ora
l bis
phos
phon
ates
are
con
train
dica
ted
in p
eopl
e w
ith a
bnor
mal
ities
of t
he
oeso
phag
us th
at d
elay
oes
opha
geal
em
ptyi
ng su
ch a
s stri
ctur
e or
ach
alas
ia, a
nd in
abili
ty to
stan
d or
si
t upr
ight
for a
t lea
st 30
–60
min
. The
y sh
ould
be
used
with
cau
tion
in p
atie
nts w
ith o
ther
upp
er g
as-
troin
testi
nal d
isor
ders
. Pre
-exi
sting
hyp
ocal
caem
ia m
ust b
e in
vesti
gate
d an
d, w
here
due
to v
itam
in D
de
ficie
ncy,
trea
ted
with
vita
min
D b
efor
e tre
atm
ent i
s ini
tiate
d (g
rade
2a)
- IV
zol
edro
nate
shou
ld b
e pr
escr
ibed
and
adm
inist
ered
onl
y by
oste
opor
osis
spec
ialis
t whe
n us
ed fo
r os
teop
oros
is m
anag
emen
t (gr
ade
2b)
- Den
osum
ab is
con
train
dica
ted
in w
omen
with
hyp
ocal
caem
ia o
r with
hyp
erse
nsiti
vity
to a
ny o
f the
co
nstit
uent
s of t
he fo
rmul
atio
n. It
s use
is n
ot re
com
men
ded
in p
regn
ancy
or i
n th
e pa
edia
tric
popu
la-
tion
(age
≤ 18
yea
rs) (
grad
e 2a
)- M
onito
ring
of c
alci
um le
vels
shou
ld b
e co
nduc
ted
prio
r to
each
dos
e of
den
osum
ab a
nd w
ithin
2
wee
ks a
fter t
he in
itial
dos
e in
pat
ient
s pre
disp
osed
to h
ypoc
alca
emia
(e.g
. pat
ient
s with
seve
re
rena
l im
pairm
ent,
crea
tinin
e cl
eara
nce ≤
30 m
L/m
in) o
r if s
uspe
cted
sym
ptom
s of h
ypoc
alca
emia
oc
cur o
r if o
ther
wis
e in
dica
ted.
Pat
ient
s sho
uld
be a
dvis
ed to
repo
rt sy
mpt
oms o
f hyp
ocal
caem
ia
(gra
de 2
a)- O
steop
orot
ic w
omen
age
< 60
yea
rs o
ld a
nd le
ss th
an 1
0 ye
ars p
ast m
enop
ause
and
low
thro
mbo
sis
risk,
who
are
into
lera
nt to
bis
phos
phon
ates
and
den
osum
ab c
an b
e co
nsid
ered
for H
RT o
r SER
M:
* If
with
vas
omot
or sy
mpt
oms a
nd lo
w c
ance
r bre
ast r
isk,
HRT
can
be
used
* If
no
uter
us: o
estro
gen
* If
ute
rus i
s pre
sent
: oes
troge
n + pr
oges
tero
ne*
If w
ithou
t vas
omot
or sy
mpt
oms a
nd h
igh
canc
er b
reas
t ris
k, S
ERM
shou
ld b
e us
ed
1 2 2 2 2 2 2
A B A A B A A
7.33
183
.33
H
Cal
cium
and
vita
min
D d
aily
su
pple
men
tal t
hera
pyEv
ery
patie
nt sh
ould
be
taki
ng c
alci
um (1
g/d
ay) a
nd v
itam
in D
(100
0 IU
/day
) sup
plem
ent t
hera
py in
ad
ditio
n to
the
oste
opor
osis
med
icat
ion.
The
dos
e ca
n be
adj
uste
d to
the
patie
nt-a
ssoc
iate
d co
mor
-bi
ditie
s- V
itam
in D
supp
lem
ent t
hera
py w
ith a
dai
ly d
ose
of 1
000
to 2
000
inte
rnat
iona
l uni
ts (I
U) i
s typ
ical
ly
requ
ired
to m
aint
ain
an o
ptim
al se
rum
25(
OH
)D le
vel.
How
ever
, hig
her d
oses
of v
itam
in D
3 m
ay b
e ne
cess
ary
in p
atie
nts w
ith p
rese
nt fa
ctor
s suc
h as
obe
sity
, mal
abso
rptio
n an
d ol
der a
ge- S
erum
25-
hydr
oxyv
itam
in D
(25[
OH
]D) s
houl
d be
mai
ntai
ned
in th
e ra
nge
of 3
0 to
50
ng/m
L in
pa
tient
s with
oste
opor
osis
2A
8.92
0.5
100
H
Archives of Osteoporosis (2021) 16:176
1 3
176 Page 12 of 20
Tabl
e 4
(con
tinue
d)
No
Dom
ain
Stat
emen
tsLE
GoR
Mea
n ra
teSD
% o
f ag
reem
ent
Leve
l of
agre
emen
t
How
is tr
eatm
ent m
onito
red?
- BM
D te
sting
can
be
used
to m
onito
r res
pons
e to
ther
apy
(gra
de 2
b)- F
RA
X c
an b
e us
ed to
mon
itor r
espo
nse
to th
erap
y (g
rade
5)
- Che
ck a
dher
ence
with
in 3
mon
ths a
nd y
early
ther
eafte
r, in
clud
ing
tole
rabi
lity,
new
cau
tions
and
co
ntra
indi
catio
ns, c
alci
um/v
itam
in D
inta
ke, c
hang
e in
frac
ture
and
fall
risks
(gra
de 2
b)- M
onito
r BM
D se
rial c
hang
es in
lum
bar s
pine
, tot
al h
ip; i
f lum
bar s
pine
, hip
or b
oth
are
not e
valu
able
, m
onito
ring
with
1/3
radi
us si
te m
ay b
e ac
cept
able
but
is li
mite
d by
a sm
all a
rea
and
a ve
ry la
rge
leas
t si
gnifi
cant
cha
nge
(LSC
) (gr
ade
2b)
- Pat
ient
s mon
itorin
g, id
eally
, sho
uld
be c
arrie
d ou
t in
the
sam
e fa
cilit
y w
ith th
e sa
me
DX
A sc
anni
ng
syste
m, p
rovi
ded
that
the
acqu
isiti
on, a
naly
sis a
nd in
terp
reta
tion
adhe
re to
Inte
rnat
iona
l Soc
iety
for
Clin
ical
Den
sito
met
ry D
XA
bes
t pra
ctic
es (g
rade
3)
- In
the
case
of o
ral b
isph
osph
onat
e or
den
osum
ab, r
epea
t BM
D m
easu
rem
ent s
houl
d be
car
ried
out
afte
r ini
tial 2
yea
rs o
f oste
opor
osis
ther
apy
to a
sses
s the
resp
onse
to tr
eatm
ent a
nd th
en a
t 5 y
ears
w
hen
the
patie
nt c
ompl
etes
the
treat
men
t cou
rse.
In th
e ca
se o
f IV
zol
edro
nate
, rep
eat D
XA
scan
sh
ould
be
carr
ied
out a
fter 3
yea
rs o
f the
rapy
(gra
de 2
a)- A
t the
repe
at B
MD
ass
essm
ent c
arrie
d ou
t 2 y
ears
afte
r sta
rting
oste
opor
osis
ther
apy,
goo
d re
spon
se
to tr
eatm
ent i
s ide
ntifi
ed if
ther
e is
incr
ease
(inc
reas
e of
the
BM
D a
bove
the
prec
isio
n er
ror)
or
stab
ility
of B
MD
with
out t
he o
ccur
renc
e of
low
trau
ma
frac
ture
(gra
de 1
)- T
reat
men
t fai
lure
is c
onsi
dere
d w
hen
the
BM
D fa
lls si
gnifi
cant
ly fr
om b
asel
ine
(by
mor
e th
an th
e pr
ecis
ion
erro
r) o
r if f
urth
er fr
actu
res t
ook
plac
e de
spite
an
adeq
uate
tria
l and
adh
eren
ce to
dru
g tre
atm
ent
- How
ever
, it i
s im
porta
nt to
real
ise
that
eve
n th
e be
st tre
atm
ents
will
onl
y de
crea
se th
e fr
actu
re ra
te
(gra
de 2
a)- P
atie
nts s
houl
d co
ntin
ue to
rece
ive
the
sam
e tre
atm
ent f
or o
steop
oros
is d
urin
g th
e in
itial
2 y
ears
of
treat
men
t eve
n if
they
exp
erie
nce
a fr
agili
ty fr
actu
re (g
rade
2a)
- If a
pat
ient
rem
ains
at h
igh
frac
ture
risk
or d
evel
op a
frag
ility
frac
ture
, or m
ore,
afte
r 2 y
ears
of b
eing
on
the
sam
e tre
atm
ent,
in sp
ite o
f goo
d ad
here
nce
to th
erap
y an
d af
ter e
xclu
sion
of s
econ
dary
cau
ses,
then
con
side
r sw
itchi
ng to
ano
ther
ther
apy
(gra
de 2
a)- I
f a p
atie
nt h
as a
new
frac
ture
, dur
ing
thei
r tre
atm
ent b
reak
, the
y sh
ould
be
reas
sess
ed im
med
iate
ly
(gra
de 2
a)- D
urin
g tre
atm
ent,
all p
atie
nts s
houl
d be
enc
oura
ged
to m
aint
ain
good
ora
l hyg
iene
, rec
eive
rout
ine
dent
al c
heck
-ups
and
repo
rt an
y or
al sy
mpt
oms s
uch
as d
enta
l mob
ility
, pai
n or
swel
ling
(gra
de 2
b)- D
urin
g tre
atm
ent,
patie
nts s
houl
d be
adv
ised
to re
port
any
thig
h, h
ip o
r gro
in p
ain
and
any
patie
nt
pres
entin
g w
ith su
ch sy
mpt
oms s
houl
d be
eva
luat
ed fo
r an
atyp
ical
fem
ur fr
actu
re (g
rade
2b)
- Dur
ing
treat
men
t with
bis
phos
phon
ate
or d
enos
umab
, pat
ient
s sho
uld
be a
dvis
ed to
repo
rt ja
w p
ain,
sw
ellin
g or
gum
infe
ctio
ns; d
evel
opm
ent o
f exp
osed
bon
e in
the
mou
th a
long
eith
er th
e to
p or
bot
-to
m ja
ws;
loos
enin
g of
teet
h; p
oor h
ealin
g of
the
gum
s esp
ecia
lly a
fter d
enta
l wor
k or
num
bnes
s or a
fe
elin
g of
hea
vine
ss in
the
jaw
(gra
de 2
b)
2 3 2 1 2 2 2 2 2 2 2
B A A A A A B B B
8.9
0.1
86.7
6H
Trea
t-to-
targ
et: W
hat i
s suc
-ce
ssfu
l tre
atm
ent o
f oste
o-po
rosi
s?
- Tre
atm
ent t
arge
t: T
scor
e > −
1.5
– ‘lo
w fr
actu
re ri
sk’ (
from
clin
ical
and
/or s
cree
ning
tests
) sho
uld
be e
stab
lishe
d pa
rticu
larly
for p
ost-
frac
ture
pat
ient
s- F
ract
ure-
free
inte
rval
of 3
to 5
yea
rs
2B
8.58
1.7
81.6
6H
Archives of Osteoporosis (2021) 16:176
1 3
Page 13 of 20 176
Tabl
e 4
(con
tinue
d)
No
Dom
ain
Stat
emen
tsLE
GoR
Mea
n ra
teSD
% o
f ag
reem
ent
Leve
l of
agre
emen
t
How
long
shou
ld p
atie
nts b
e tre
ated
?- O
ral b
isph
osph
onat
e tre
atm
ent s
houl
d la
st fo
r 5 y
ears
, whe
reas
for I
V z
oled
rona
te th
erap
y sh
ould
last
for 3
yea
rs- C
ontin
uatio
n of
ora
l bis
phos
phon
ate
(ale
ndro
nate
and
rise
dron
ate)
trea
tmen
t bey
ond
5 ye
ars c
an
gene
rally
be
reco
mm
ende
d in
the
follo
win
g si
tuat
ions
:- F
ract
ure
risk
rem
ains
hig
h- T
-sco
re −
2.5
or le
ss- P
revi
ous h
istor
y of
a h
ip o
r ver
tebr
al fr
actu
re- C
urre
nt tr
eatm
ent w
ith o
ral g
luco
corti
coid
s ≥ 7.
5 m
g pr
edni
solo
ne/d
ay o
r equ
ival
ent
- Occ
urre
nce
of o
ne o
r mor
e lo
w tr
aum
a fr
actu
res w
hilst
on
ther
apy,
afte
r exc
lusi
on o
f poo
r adh
eren
ce
to tr
eatm
ent (
e.g.
less
than
80%
of t
reat
men
t has
bee
n ta
ken)
and
afte
r cau
ses o
f sec
onda
ry o
steop
o-ro
sis h
as b
een
excl
uded
. In
such
cas
es, c
lass
switc
hing
may
be
cons
ider
ed (g
rade
2a)
- Den
osum
ab th
erap
y sh
ould
initi
ally
last
for 5
yea
rs (g
rade
2a)
. If d
enos
umab
ther
apy
is d
isco
ntin
ued,
pa
tient
s sho
uld
be tr
ansi
tione
d to
ano
ther
ant
ireso
rptiv
e- W
hene
ver i
ndic
ated
, the
follo
win
g th
erap
ies c
an b
eco
ntin
ued
for:
•10
year
s—al
endr
onic
aci
d an
d de
nosu
mab
•7 y
ears
—ris
endr
onic
aci
d•3
yea
rs—
zole
ndro
nic
acid
- Par
athy
roid
hor
mon
e th
erap
y 20
μg
daily
for a
max
imum
dur
atio
n of
trea
tmen
t of 2
4 m
onth
s (gr
ade
2a).
The
med
icat
ion
shou
ld b
e fo
llow
ed b
y a
drug
inte
nded
for l
ong-
term
use
, suc
h as
a b
isph
osph
o-na
te o
r den
osum
ab) (
grad
e 1)
- Rom
osoz
umab
ther
apy
shou
ld la
st fo
r 12
mon
ths.
The
med
icat
ion
shou
ld b
e fo
llow
ed b
y a
drug
in
tend
ed fo
r lon
g-te
rm u
se, s
uch
as a
bis
phos
phon
ate
or d
enos
umab
(gra
de 2
)
2a
8.58
0.82
91.7
6H
Dru
g ho
liday
- Dru
g ho
liday
can
be
cons
ider
ed a
fter c
ompl
etin
g 5
year
s of o
ral b
isph
osph
onat
e/de
nosu
mab
ther
apy
or 3
yea
rs o
f zol
edro
nate
IV th
erap
y if
the
targ
et o
f tre
atm
ent h
as b
een
achi
eved
(gra
de 2
a)- P
atie
nts w
ith lo
w to
mod
erat
e fr
actu
re ri
sk: c
onsi
der g
ivin
g bi
spho
spho
nate
then
stop
ping
for a
dru
g ho
liday
(gra
de 2
a)- O
nce
a ho
liday
has
beg
un, f
ract
ure
risk
and
BM
D sh
ould
be
re-e
valu
ated
eve
ry 1
to 3
yea
rs a
fter
disc
ontin
uatio
n- T
he e
ndin
g of
a b
isph
osph
onat
e ho
liday
shou
ld b
e ta
ilore
d to
the
patie
nt’s
bon
e he
alth
stat
us, s
uch
as
a si
gnifi
cant
dro
p in
BM
D (b
y m
ore
than
a p
reci
sion
err
or) o
r inc
reas
e in
the
frac
ture
risk
may
lead
to
re-in
itiat
ion
of o
steop
oros
is th
erap
y, d
epen
ding
on
the
indi
vidu
al’s
frac
ture
risk
bef
ore
the
5-ye
ar
max
imum
hol
iday
is c
ompl
eted
- Pat
ient
s on
gluc
ocor
ticoi
ds (≥
7.5
mg/
day)
or p
atie
nts w
ho h
ave
had
a ve
rtebr
al fr
actu
re sh
ould
not
us
ually
be
cons
ider
ed fo
r a tr
eatm
ent b
reak
2A
8.67
1.25
91.6
6H
Wha
t is t
he ro
le o
f con
com
itant
us
e of
ther
apeu
tic a
gent
s?C
ombi
natio
n th
erap
y of
par
athy
roid
hor
mon
e an
d de
nosu
mab
may
be
cons
ider
ed in
ver
y hi
gh fr
actu
re
risk
patie
nts.
This
shou
ld b
e co
nsid
ered
on
an in
divi
dual
bas
is; p
atie
nts s
houl
d be
ass
esse
d an
d m
an-
aged
by
oste
opor
osis
spec
ialis
t (gr
ade
2b)
2B
8.58
0.82
82.3
3H
Archives of Osteoporosis (2021) 16:176
1 3
176 Page 14 of 20
Tabl
e 4
(con
tinue
d)
No
Dom
ain
Stat
emen
tsLE
GoR
Mea
n ra
teSD
% o
f ag
reem
ent
Leve
l of
agre
emen
t
Wha
t is t
he ro
le o
f seq
uent
ial
use
of th
erap
eutic
age
nts?
- In
postm
enop
ausa
l wom
en w
ith o
steop
oros
is a
t ver
y hi
gh ri
sk o
f fra
ctur
e, p
artic
ular
ly th
ose
with
his
-to
ry o
f oste
opor
otic
ver
tebr
al fr
actu
re, s
eque
ntia
l the
rapy
can
be
adop
ted
with
an
anab
olic
age
nt (e
.g.
abal
opar
atid
e, ro
mos
ozum
ab, t
erip
arat
ide)
follo
wed
with
a b
isph
osph
onat
e or
den
osum
ab to
pre
vent
bo
ne d
ensi
ty d
eclin
e an
d lo
ss o
f fra
ctur
e effi
cacy
- Seq
uent
ial t
hera
py st
artin
g w
ith p
arat
hyro
id h
orm
one
is a
n op
tion
for t
reat
men
t of o
steop
oros
is in
po
stmen
opau
sal w
omen
who
are
at v
ery
high
risk
for f
ract
ure
parti
cula
rly th
ose
who
hav
e pa
st hi
s-to
ry o
f mul
tiple
ver
tebr
al fr
actu
res.
This
shou
ld b
e de
cide
d an
d pr
escr
ibed
by
oste
opor
osis
spec
ialis
t- S
eque
ntia
l the
rapy
star
ting
with
rom
osoz
umab
is a
n op
tion
for t
reat
men
t of o
steop
oros
is in
pos
t-m
enop
ausa
l wom
en w
ho a
re a
t ver
y hi
gh ri
sk fo
r fra
ctur
e pa
rticu
larly
thos
e w
ho h
ave
past
histo
ry o
f hi
p or
ver
tebr
al fr
actu
res.
This
shou
ld b
e de
cide
d an
d pr
escr
ibed
by
oste
opor
osis
spec
ialis
t
2B
8.67
0.82
91.6
7H
The
role
of v
erte
bral
aug
-m
enta
tion
for c
ompr
essi
on
frac
ture
s?
Kyp
hopl
asty
/ver
tebr
opla
sty a
re n
ot re
com
men
ded
as fi
rst-l
ine
treat
men
t of v
erte
bral
frac
ture
s, gi
ven
an u
ncle
ar b
enefi
t on
over
all p
ain
and
a po
tent
ial i
ncre
ased
risk
of v
erte
bral
frac
ture
s in
adja
cent
ve
rtebr
ae (g
rade
1)
1A
8.67
0.5
84.1
H
Impl
emen
tatio
n of
FLS
Frac
ture
liai
son
serv
ices
(FLS
) sho
uld
be p
rovi
ded
for a
ll pa
tient
s sus
tain
ing
a fr
agili
ty fr
actu
re:
- Ens
ure
treat
men
t ini
tiatio
n w
ithin
8–1
2 w
eeks
of f
ract
ure
- FLS
shou
ld b
e pa
tient
-cen
tred
and
inte
grat
ed b
etw
een
orth
opae
dic
surg
ery,
orth
oger
iatri
cs, r
heum
a-to
logy
and
oste
opor
osis
cen
tres o
f car
e- P
hysi
cian
s sho
uld
follo
w u
p pa
tient
s at 4
and
12
mon
ths t
o re
view
the
use
of m
edic
atio
ns th
at
incr
ease
the
risk
of fa
lls a
nd/o
r fra
ctur
e, to
ens
ure
co-p
resc
riptio
n of
cal
cium
and
vita
min
D w
ith
bone
pro
tect
ive
inte
rven
tions
and
to m
onito
r adh
eren
ce to
ther
apy
2A
8.83
0.5
100
H
The
impo
rtanc
e of
fall
asse
ss-
men
tFa
lls ri
sk sh
ould
be
asse
ssed
for e
very
pat
ient
eva
luat
ed fo
r fra
ctur
e ris
k (g
rade
2a)
2A
991
.4H
Oste
opor
osis
in m
enO
steop
oros
is sc
reen
ing
in m
en sh
ould
be
carr
ied
out i
n th
e ag
e of
70
year
s or o
lder
- Men
at a
ge le
ss th
an 7
0 ye
ars o
ld c
an b
e as
sess
ed fo
r oste
opor
osis
if th
ey d
evel
op ri
sk fa
ctor
s- M
en w
ith o
steop
aeni
a (T
scor
e fro
m −
1 to
− 2.
5) w
ho h
ave
mod
erat
e ris
k of
frac
ture
FR
AX
frac
ture
ris
k pr
obab
ility
1–3
% a
t the
hip
and
10–
20%
at s
pine
may
be
good
can
dida
tes f
or p
roph
ylac
tic z
ole-
dron
ic a
cid
ever
y 18
mon
ths f
or 4
infu
sion
s- F
or th
e pu
rpos
es o
f FR
AX
cal
cula
tions
, the
BM
D T
-sco
res i
n m
en a
re c
alcu
late
d ba
sed
on th
e fe
mal
e re
fere
nce
data
base
- Sec
onda
ry c
ause
s of o
steop
oros
is a
re c
omm
only
foun
d am
ongs
t men
, so
this
pop
ulat
ion
requ
ires
thor
ough
inve
stiga
tion
- Int
erve
ntio
n th
resh
olds
for m
en a
re si
mila
r to
thos
e re
com
men
ded
for w
omen
- All
men
star
ting
on a
ndro
gen
depr
ivat
ion
ther
apy
shou
ld h
ave
thei
r fra
ctur
e ris
k as
sess
ed- C
onsi
der r
efer
ring
men
with
oste
opor
osis
to sp
ecia
list c
entre
s, pa
rticu
larly
you
nger
men
or t
hose
w
ith se
vere
dis
ease
- Men
are
ass
esse
d an
d tre
ated
follo
win
g th
e sa
me
man
agem
ent p
roto
col s
ugge
sted
abov
e fo
r pos
t-m
enop
ausa
l wom
en, e
xclu
ding
the
HRT
2A
8.75
0.5
94.1
H
Archives of Osteoporosis (2021) 16:176
1 3
Page 15 of 20 176
Tabl
e 4
(con
tinue
d)
No
Dom
ain
Stat
emen
tsLE
GoR
Mea
n ra
teSD
% o
f ag
reem
ent
Leve
l of
agre
emen
t
Patie
nts o
n gl
ucoc
ortic
oids
th
erap
y- W
omen
and
men
age
≥ 70
yea
rs, w
ith a
pre
viou
s fra
gilit
y fr
actu
re o
r tak
ing
high
dos
es o
f glu
coco
r-tic
oids
(≥ 7.
5 m
g/da
y pr
edni
solo
ne) s
houl
d be
con
side
red
for b
one
prot
ectiv
e th
erap
y, a
fter B
MD
ba
selin
e as
sess
men
t- I
n ot
her i
ndiv
idua
ls, f
ract
ure
prob
abili
ty sh
ould
be
estim
ated
usi
ng F
RA
X w
ith a
djus
tmen
t for
glu
co-
corti
coid
dos
e. B
asel
ine
BM
D a
sses
smen
t is a
dvis
ed- B
one-
prot
ectiv
e tre
atm
ent s
houl
d be
star
ted
at th
e on
set o
f glu
coco
rtico
id th
erap
y in
indi
vidu
als a
t m
oder
ate/
high
risk
of f
ract
ure
- Ale
ndro
nate
and
rise
dron
ate
are
first-
line
treat
men
t opt
ions
. Whe
re th
ese
are
cont
rain
dica
ted
or n
ot
tole
rate
d, z
oled
roni
c ac
id, t
erip
arat
ide
or d
enos
umab
(in
orde
r) a
re a
ltern
ativ
e op
tions
- Bon
e-pr
otec
tive
ther
apy
may
be
appr
opria
te in
som
e pr
emen
opau
sal w
omen
and
you
nger
men
, par
-tic
ular
ly in
indi
vidu
als w
ith a
pre
viou
s hist
ory
of fr
actu
re o
r rec
eivi
ng h
igh
dose
s of g
luco
corti
coid
s- F
or w
omen
in th
e ch
ildbe
arin
g pe
riod:
the
first-
line
ther
apy
is a
n or
al b
isph
osph
onat
e; se
cond
-line
th
erap
y is
a p
arat
hyro
id h
orm
one
2A
8.58
1.25
91.6
7H
COV
ID-1
9 an
d os
teop
oros
is- P
atie
nts d
o no
t war
rant
hig
her p
riorit
izat
ion
for v
acci
natio
n ag
ains
t CO
VID
-19
due
to th
eir o
steop
o-ro
sis
- Sta
ndar
d no
n-ph
arm
acol
ogic
app
roac
hes f
or o
ptim
izat
ion
of b
one
heal
th in
clud
e m
aint
enan
ce o
f vita
-m
in D
supp
lem
enta
tion,
mai
nten
ance
of a
dequ
ate
phys
ical
act
ivity
and
adh
eren
ce to
a b
alan
ced
diet
; th
ese
strat
egie
s sho
uld
be c
ontin
ued
beca
use
of th
eir m
uscu
losk
elet
al b
enefi
ts a
nd th
eir p
oten
tial
role
s as f
acili
tato
rs o
f im
mun
ocom
pete
nce
- Oste
opor
osis
ther
apie
s do
not i
ncre
ase
the
risk
or se
verit
y of
CO
VID
-19
infe
ctio
n an
d do
not
inte
r-fe
re w
ith th
e effi
cacy
or s
ide
effec
t pro
file
of C
OV
ID-1
9 va
ccin
es- O
ral b
isph
osph
onat
es, a
s wel
l as t
he se
lf-ad
min
ister
ed sk
elet
al a
nabo
lic a
gent
s, te
ripar
atid
e an
d ab
alop
arat
ide,
shou
ld n
ot b
e di
scon
tinue
d du
ring
vacc
inat
ion
It’s r
ecom
men
ded
an in
terv
al o
f 1 w
eek
betw
een
intra
veno
us b
isph
osph
onat
e in
fusi
on a
nd C
OV
ID-1
9 va
ccin
atio
n be
caus
e of
the
poss
ibili
ty o
f tre
ated
pat
ient
s dev
elop
ing
an a
cute
pha
se re
actio
n as
a
resu
lt of
adm
inist
ratio
n of
eith
er a
gent
- In
term
s of d
enos
umab
and
rom
osoz
umab
, it s
eem
s pru
dent
to a
llow
for a
n in
terv
al o
f 4 to
7 d
ays
betw
een
thes
e dr
ugs a
nd v
acci
natio
n be
caus
e of
put
ativ
e in
ject
ion
site
reac
tions
2B
8.63
0.82
94.1
H
LE, l
evel
of e
vide
nce
acco
rdin
g to
the
Oxf
ord
Cen
tre fo
r Evi
denc
e-B
ased
Med
icin
e (C
EBM
) crit
eria
; H, h
igh
leve
l of a
gree
men
t; GoR
, gra
de o
f rec
omm
enda
tions
; COVID
, cor
onav
irus d
isea
se
Archives of Osteoporosis (2021) 16:176
1 3
176 Page 16 of 20
DXA machines. In other cases, it was linked to its prohibi-tive cost, even where the DXA machines are available [38]. Furthermore, the limitations of BMD for risk assessment have been one of the motives for the development of fracture risk prediction algorithms that integrate clinical risk factors for fracture. There are several fracture risk assessment tools available. Of these, the FRAX tool. (https:// www. sheffi eld. ac. uk/ FRAX/ tool. aspx) has been the most extensively used. FRAX calculates the 10-year probability of a major fracture
(clinical spine, humerus or wrist fracture) and 10-year prob-ability of a hip fracture. A unique feature of FRAX is that it is based on a countries’ epidemiological data and considers competing mortality in the fracture risk estimation proce-dure [19].
Unfortunately, in Africa, there is a huge treatment gap between those at risk of fracture and those receiving treat-ment for the prevention of fragility fractures. Both the eco-nomic and societal burden of osteoporotic fragility fractures
Fig. 2 An algorithm sum-marising the fracture-centric approach and the group’s consensus recommendations for the management of osteoporosis patients stratified according to their fracture risk. Case finding and management approach were set up according to the fracture risk category. The determina-tion of fracture risk was carried out based on fracture risk score calculation (e.g. FRAX) and the measurement of lumbar spine and hip BMD
Osteoporosis Screen Risk Factors
Low Moderate
BMD
High Very High
FRAX*Fracture Probability
Reassess Fracture Probability
HighNot High (Moderate)
*Calcium and Vitamin D suppl.*Risk appropriate exercise*Reassurance*Lifestyle advice
* Reassess when addi�onal risk factors develop
Bisphosphonates (oral/IV) for 3-5 years
Denosumab (5-10 years)
Or any other
an�resorp�ve +
Calcium and vitamin D suppl.
*AppropriateExercise*Lifestyle advice
Urgent referral to Osteoporosis specialist
Anabolic agent:
Romosozumab (1-year) or parathyroid hormone (18-24 months) therapy followed by inhibitor of bone resorp�on, then drug holiday#
*Consider cost effec�ve/biosimilar therapy
Consider Zoledronate (5mg IV) every 18-months, 4 doses-May consider oral bisphosphonate#Then stop for drug holiday.
Monitor Therapy: Clinic visit within 3-months then yearly. FRAX / BMD at 2 and 5-years from star�ng
Lifestyle modifica�ons: Recommended for all pa�ents irrespec�ve of risk Modifica�ons include: *exercise, strength, and balance training *diet *calcium/vitamin D *stop smoking *≤2 units/day alcohol *Tailor advice to each pa�ent’s own circumstances and comorbidi�es
Remain at high riskCon�nue Therapy or switch to another therapy, e.g. parathyroid hormone or romosozumab
Target: Treatment target: BMD: T score > − 1.5. Fracture risk below the treatment threshold or FRAX major osteoporosis fracture probability < 10%, hip fracture risk probability < 3%. Fracture-free interval of 3 to 5 years
Archives of Osteoporosis (2021) 16:176
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Page 17 of 20 176
is enormous and is expected to rise owing to an increasing skew towards an older population [9, 10]. However, over the last two decades, there has been a significant shift towards the better ability to predict those at risk, using fracture pre-diction tools and an increasing understanding of scanning modalities, such as DXA or qualitative ultrasound scans [38]. This will allow appropriate earlier identification of patients with osteopenia or osteoporosis, who are at high or very high risk of fracturing, to benefit from osteoporo-sis therapy. Furthermore, a variety of generic therapeutic options are now available, at economically feasible prices. The developed guidelines endorse this armamentarium and provide a solid background to making appropriate treatment decisions, which is a step forward towards closing this gap in Africa.
The paradigm of treat-to-target aims at enhanced and individualised care of osteoporotic patients. Such strategy enables the treating clinicians to select the most appropriate initial osteoporosis therapy and guides subsequent decisions to continue, change or stop treatment [19, 33, 39]. Though some publications revealed that FRAX can be used to pre-dict new posttreatment fracture probability and assess the reduction in the fracture risk in women currently on osteopo-rosis therapy [40, 41], the predominant trend is that FRAX cannot be used to monitor response to therapy. On the other hand, repeat DXA informs on the long-term treatment effect on BMD. The new concept of very high fracture risk and the development of new intervention thresholds [30, 42] provide a new manifesto based on which this guideline has been developed. The very high fracture risk and the consequent further utility loss immediately after a subsequent fracture (imminent risk) suggest that preventive treatment given as soon as possible after fracture would avoid a higher number of new fractures and reduce the attendant morbidity, com-pared with the treatment given later [30, 43].
Monitoring of patients on osteoporosis therapy should include regular communication with a health care profes-sional to make sure that (1) the osteoporosis therapy is taken correctly and regularly as well as to ensure that treatment has been initiated within 16 weeks of non-traumatic frac-ture; (2) calcium and vitamin D supplement therapy are taken regularly and in appropriate dose (check adherence at 3 months and at 12 months); (3) address any concerns or adverse effects the patient might have; and (4) there are no comorbidities or other medications that might impact the expected treatment outcome. Whilst BMD is considered a surrogate marker for bone strength and fracture risk, stability or a significant increase in BMD is considered an acceptable treatment outcome and is associated with a reduction in frac-ture risk [44]. The time interval when treatment effect can be detected may vary depending on treatment modality, risk factors and current medications. A DXA scan should only be repeated if the results will impact the clinical management,
or if changes in BMD are expected to exceed the least sig-nificant change (LSC) for the DXA equipment used. The annual rates of loss during these intervals are approximately 1.8–2.3% in the spine and 1.0–1.4% in the hip. This is well below the least significant change (LSC), averaging 2–3% for most DXA machines at the total hip. Therefore, repeat DXA scan should be considered after 2–3 years of the for-mer scan, which has been recommended in this guideline. The target of bone mineral density (BMD) (in the range of − 1.5 to − 2) as suggested in this guideline agrees with those reported in other studies [19, 30, 39].
This guideline includes health care professionals from the entire African continent, ensuring that all the regions have been covered and represented; therefore, it is expected to be implemented across the whole of Africa. The aim is to streamline the osteoporosis service provided to the patients across the continent and ensure that osteoporosis therapy is determined or escalated according to the patient’s risk factors and fracture risk within an approved framework. The Delphi technique has proven to be a reliable measure-ment instrument in developing new concepts and setting the direction of future-orientated research [16]. In Delphi methodology, consensus usually arises when agreement or disagreement ranges from 50 to 80% [17]. In our work, the agreement ranged between 83.3 and 100%, indicating a strong trend amongst the African health care professionals to have a treat-to-target approach for osteoporosis manage-ment. These findings agree with the results of the Span-ish consensus on osteoporosis management [45] as well as the Egyptian guidelines for osteoporosis management [31], which revealed similar scores on the treat to target policy.
Limitations of the guideline This guideline reflects the best data available at the time the report was prepared. Caution should be exercised in interpreting the data; the results of future studies may require alteration of the conclusions or recommendations in this report. It may be necessary or even desirable to depart from the guidelines in the interests of specific patients and special circumstances. Just as adher-ence to guidelines may not constitute defence against a claim of negligence, so deviation from them should not necessarily be deemed negligent.
Plans for guideline revision This field of osteoporosis thera-peutics is in a rapid phase of development, and revision of the scope and content of the guideline will therefore occur on regular basis. Where necessary, the guideline will be updated.
In conclusion, with changing demography, the cost of treating osteoporosis is expected to increase considerably in Africa by the year 2030. Understanding of the impact of clinical risk factors can influence prevention and treatment of osteoporotic fractures. Therefore, it is vital to screen the
Archives of Osteoporosis (2021) 16:176
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176 Page 18 of 20
patients and stratify them according to their identified frac-ture risk. This was a wide and representative panel of experts who established consensus regarding the management of postmenopausal osteoporosis in Africa. It also expanded to give guidance for the management of osteoporosis in men and the potential role of fracture liaison service in standard practice. The algorithm developed in this study facilitates the incorporation of several recent developments into the standard patient management protocols.
Declarations
Conflicts of interest None.
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Authors and Affiliations
Y El Miedany1,2 · Farhanah Paruk3 · Asgar Kalla4 · A. Adebajo5 · Maha El Gaafary6 · Abdellah El Maghraoui7 · Madeleine Ngandeu8 · Dzifa Dey9 · Naglaa Gadallah10 · Mohamed Elwy10 · Farzana Moosajee11 · Mohammed Hassan Abu‑Zaid12 · Salwa Galal10 · Soussen Miladi13 · Waleed Hassan14 · Abubaker Fadlelmola15 · Sally Saber10
Farhanah Paruk [email protected]
Asgar Kalla [email protected]
A. Adebajo [email protected]
Maha El Gaafary [email protected]
Abdellah El Maghraoui [email protected]
Madeleine Ngandeu [email protected]
Dzifa Dey [email protected]
Naglaa Gadallah [email protected]
Mohamed Elwy [email protected]
Farzana Moosajee [email protected]
Mohammed Hassan Abu-Zaid [email protected]
Salwa Galal [email protected]
Soussen Miladi [email protected]
Waleed Hassan [email protected]
Abubaker Fadlelmola [email protected]
Sally Saber [email protected]
1 Canterbury Christ Church University, Canterbury, UK2 King’s College, London, UK3 University of KwaZulu-Natal, Durban, South Africa4 University of Cape Town, Cape Town, South Africa5 University of Sheffield, Sheffield, UK6 Community and Public Health, Ain Shams University, Cairo,
Egypt7 Mohamed V University, Rabat, Morocco8 Faculty of Medicine and Biomedical Sciences, The
University of Yaoundé 1, Yaoundé, Cameroon9 University of Ghana Medical School, Accra, Ghana10 Rheumatology and Rehabilitation, Ain Shams University,
Cairo, Egypt11 Tygerberg Hospital and Stellenbosch University, Cape Town,
South Africa12 Rheumatology and Rehabiliation, Tanta University, Tanta,
Egypt13 Faculty of Medicine of Tunis, University of Tunis El Manar,
Tunis, Tunisia14 Rheumatology and Rehabilitation, Benha University, Benha,
Egypt15 Ahmed Gasim Teaching Hospital, Khartoum North, Sudan