Evercare Colorado

Hip Fracture & Vitamin D Update

November 2007Gregory Gahm, MD

Evercare Colorado

Informational Tidbits

60-90% of NH residents fall annually 20-50% of LTC pts who fall DIE the following year 33% who have a hip fracture never walk again From start (ambulance) to finish (therapy ends), the

average direct cost of treating a hip fracture in Colorado is about $30,000 (Taxpayers pay most of it…)

Falls and hip fractures account for a significant percentage of malpractice suits and formal complaints against NHs

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Statistics Review

RR = Relative RiskCI = Confidence Interval RR is reported with a Confidence Interval statistically

calculated based on magnitude of measured difference, # of study subjects, time…

RRs w/ CIs: < 1.0: Result less likely to happen w/ Intervention > 1.0: Result more likely to happen w/ Intervention When CI includes 1.0: Can’t tell If CI does not include 1.0, there is a 95% chance

the same result would occur no matter how many times you repeat the study

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Falls and Fractures

Interventions shown to decrease falls in community-dwelling elderly: Muscle strengthening / balance retraining [RR 0.80*; CI* 0.66-0.98] 15 Week Tai Chi group exercise [RR 0.51; CI 0.36-0.73] - only for

active participants; benefits disappeared when exercise stopped Withdrawal of psychotropic medication [RR 0.34; CI 0.16-0.74] Multidisciplinary, multifactorial, health/environment RF screening

/intervention trials {No Rx changes} [RR 0.79; CI 0.67-0.94]

Same interventions in LTCFs are markedly less effective

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Hip Fractures and PPIs

Pts >50 yo on Proton Pump Inhibitors (eg, Prilosec, Prevacid, Aciphex, Nexium, Omeprazole, Protonix)

13,556 hip fracture cases compared to 135,000 matched controls in the UK

RR of hip fracture increased with dose, duration and age >1 year: RR = 1.44 [CI = 1.3-1.6]

High Dose*: RR = 2.65 [CI = 1.8-3.9]*(>1.75x avg qd dose)

JAMA, Dec 27, 06; Vol 296: 2947-53

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Clinical Trials of External Hip Protectors

Early studies with < 50% compliance:

Lauritzen (Lancet, 1993) 31 hip fxs in 418 controls [7.5%] vs 8 in 247 [3.2%] in treatment group. NONENONE on a pad protected hip.

Kannus (NEJM, 2000) 21 hip fxs / 1000 pt-yrs [protected] vs 46 in the control group. 44 fxs on a pad protected hip.

Ekman (Lancet, 1997) 21 hip fxs during study period NONENONE on a pad protected hip.

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Clinical Trials of EHPs

Wiener & Birge (02): 19 fractures / 310 patient-years on unprotected hips - vs - 1 fracture / 320 patient-years on protected hips

Pooled data from 6 major trials: 3553 subjects Hip fxs in 2.2% of those with EHPs vs 6.2% of control group Average compliance rates estimated to be about 40% NNT to prevent 1 fracture / year is 25-40 with

40% compliance or 10-12 with 85% compliance

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NH Chain National Hip Protector Study

14,000 patients in facilities were given the opportunity to wear hip protectors

- 7000 chose NOT to wear them.

- 7000 chose to wear hip protectors

Compliance was estimated to be 55-70%

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NH Chain National Hip Protector Study

At the end of 1 year / 3500 pt-years:

In those NOT wearing Hip Protectors…

115 Fractures (= 33 Fractures per 1000 residents annually)

In the Hip Protector Intention to Treat group…

45 Fractures (= 13 Fractures per 1000 residents annually)

Only 3 were in patients wearing EHPs

Comparing ‘Wearers’ to ‘NON-wearers’ –> 3 vs 42 Fxs or 0.8 vs 12 Fractures / 1000 Patient-Years

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The HIP PRO RCT

Efficacy of a Hip Protector to Prevent Hip Fracture in NH Residents 1042 NH Residents, Mean age 85 Left or Right Pad Only 8 month avg participation Compliance checked 3x/wk: 60-80% avg

Results: Same incidence of fractures on padded vs unpadded hips

JAMA; July 25, 2007; Vol 298: 413-22

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The Rebuttal

1. The JAMA article used a Hip Protector that has not been available since 2003!

2. The study pad and the one that replaced it were tested using a drop weight system in 2004. The study pad absorbed 30% of peak force, the replacement 75-90%

3. Most brands currently available still absorb only 25-35% of peak force, which may not be adequate to prevent a fracture

4. Human volunteer fallers using the new pad in 2004 did > 400 falls without pain or hip injury

5. Fall reflex characteristics (the baby / ice argument)

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So, are the major brands of EHPs available equivalent?

No. Brand makes a difference.

Some brands tested in RCTs have shown dramatic reductions in hip fractures (FallGard) or at least statistically significant decreases (HipSavers)

Some have shown NO difference or even MORE fractures (usu due to poor design, inadequate pad, or pad placement)

Many have never been studied in RCTs

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Evercare ColoradoHip Protector Study

3 3 Facilities chosen that historically [98-2001] had the highest number of hip fractures. There were 1616 hip fractures among 200 patients in the previous 7 months(Annually, 27.5 hip fractures would be expected to occur in this group, a number that was consistent from 1998-2001)

180 of these patients were identified as being at highest risk and given Hip Protectors (FallGard)

The 20 patients deemed to be at lowest risk for falls were excluded from the study

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Evercare Hip Protector Study

There were 3 hip fractures among these 180 pts the following year…

…none of them were wearing their hip protectors at the time of their fall / fracture

PS. There were also 3 fractures among the 20 persons excluded from the study…

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Implementation Issues

Lost Briefs Mark them well / Inservice Staff

Acceptance by Facilities Significant financial savings from keeping census up and patients alive Fewer Complaint Surveys / Law suits Improved MDS data (better surveys?) No F Tags for ‘acceptable’ noncompliance rates

SIGNIFICANT findings studies all had only 35-60% compliance

Acceptance by Patients & Familes Nonpharmacologic treatment that works Families / patients appreciate the risk reduction in death, permanent disability, hospitalization

/ surgery, loss of Ambulation & Independent skills…

Noncompliance Takes about 2-6 weeks for patients to get used to them Routine Checks + immediate feedback to nursing & CNAs Assistance from families – use information sheets

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Ordering FallGard Hip Protectors

FallGard631 Alexandria DrNaperville, IL 60565800-828-0702Fax 630-369-5219www.fallgard.comSizes: XS, S, M, L, XL, XXL, XXXLOrder the “Sewn-In Pad” version

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Vitamin D: The Basics

1.1. Essential for adequate intestinal absorption Essential for adequate intestinal absorption of Caof Ca++++

2.2. Vitamin D insufficiencyVitamin D insufficiency:: Can compromise muscle strength & impair lower extremity Can compromise muscle strength & impair lower extremity

functionfunction Associated with Increased Arterial CalcificationAssociated with Increased Arterial Calcification Occurs in 75-85% of patients with Chronic Kidney DiseaseOccurs in 75-85% of patients with Chronic Kidney Disease

(Prevalence of CKD in NHs is likely >60-75%(Prevalence of CKD in NHs is likely >60-75%)) Leads to Increased PTH -–> Higher Bone TurnoverLeads to Increased PTH -–> Higher Bone Turnover

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Vitamin D: The Problem

MostMost LTC residents have insufficient / LTC residents have insufficient / deficient levels of Vitamin Ddeficient levels of Vitamin D ––> > 70-98% in recently published studies70-98% in recently published studies

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Vitamin D and FallsMeta-analysis of RCTs in elderly (n=1237) -> 700 IU D2 = Avg Dose

Vitamin D reduced risk of falling by 22%(OR 0.78; 95% CI (0.64-0.92) compared to Ca++ or placebo

JAMA, April 28, 2004; Vol 291: 1999-2005

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Dosage of Vitamin D Needed to Reduce Falls

N=125 LTC residents 5 months of D2 supplements 200, 400, 600 or 800 IU qd 800 IU supplement was not enough to achieve “sufficient” Serum

25(OH) levels in 50% of those treated

Units / day 25 (OH) Vit D ng/ml RR falls0 24 +13 1.0200 24+8 1.10400 22+9 1.05600 24+9 1.21800 30+6 0.28* (.10-.75)

JAGS 2007; 55:234

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Vitamin D2 vs D3

Most standard CaMost standard Ca++++ combinations contain 200 IU of Vit D2 combinations contain 200 IU of Vit D2-> Available as 400 IU Caps & usu given 3 qd-> Available as 400 IU Caps & usu given 3 qd

-> -> D2 is only 2/3 as effective in raising Vit D levels as D3 -> -> 200 U Vitamin D2 =~ 140 U D3-> -> Daily rec for Vit D2 would be 1500 IU qdDaily rec for Vit D2 would be 1500 IU qd

Vitamin D3 Caps of 50,000 & 5,000 units are available Vitamin D3 Caps of 50,000 & 5,000 units are available and can be given monthlyand can be given monthly (always with a meal) (always with a meal)-> Give with meals that contain fats or oils to stimulate bile acids -> Give with meals that contain fats or oils to stimulate bile acids

& improve absorption& improve absorption

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Vitamin D3

1.1. Supplementation with 800-1200 IU qd of Vit D3 in Supplementation with 800-1200 IU qd of Vit D3 in seniors reduces both seniors reduces both falls falls andand fractures fractures by 20-30% by 20-30%

2.2. Alternatively, give Alternatively, give 50,000 IU q month of Vitamin D50,000 IU q month of Vitamin D333.3. Lower doses have much less effect & do not Lower doses have much less effect & do not

correlate with decreased fracture rates with or correlate with decreased fracture rates with or without Cawithout Ca++++ supplementation supplementation

4.4. 800 IU of Vitamin D3 qd undertreats 50% of pts800 IU of Vitamin D3 qd undertreats 50% of pts5.5. Current AMDA guideline: Current AMDA guideline: 1000 IU of Vitamin D3 qd1000 IU of Vitamin D3 qd

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Vitamin D: Resident Safety

Residents with Stage IV Kidney disease (GFR <15) may not Residents with Stage IV Kidney disease (GFR <15) may not benefit from getting Vitamin Dbenefit from getting Vitamin D33

History of Kidney Stones is generally not a contraindication, History of Kidney Stones is generally not a contraindication, but history must be reviewed carefullybut history must be reviewed carefully

Recent studies show that doses of 100,000 - 130,000 IU / mo Recent studies show that doses of 100,000 - 130,000 IU / mo did did notnot lead to adverse effects lead to adverse effects

No need to test Vit D-25(OH) routinely!No need to test Vit D-25(OH) routinely! LLab test is MUCH more expensive (circa $50) than years of treatment Prevalence is high enough to assume >4 of 5 elderly patients are deficient Treating pts who aren’t deficient is very unlikely to cause harm & may have benefits

Malabsorption syndromes may require higher doses & Malabsorption syndromes may require higher doses & measurement of 25 (OH) Vit D levels to find effective dosemeasurement of 25 (OH) Vit D levels to find effective dose

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Vit D Deficiency & Prostate Cancer

14,916 men in Physicians' Health Study initially cancer-free

After 18 yrs of F/U, 1,066 subjects were identified with incident Prostate CA & compared their Vit D status with that of 1,618 cancer-free, age- and smoking-matched controls

Men with below-median levels of Vit D had a significantly higher risk of aggressive Prostate CA (OR 2.1)

Men with below-median levels of Vit D & the Vit D receptor polymorphism FokI ff had a higher risk of total and aggressive Prostate CA than those with above-median levels and the Ff or FF genotype (OR 1.9 & 2.5, respectively).

Overall, 13-51% of the physicians in the study were Vit D deficient in the summer/fall & 36-77% were deficient in the winter/spring

Li H, Stampfer MJ, Hollis JBW, Mucci LA, Gaziano JM, et al. (2007) A Prospective Study of Plasma Vitamin D Metabolites, Vitamin D Receptor Polymorphisms, and Prostate Cancer. PLoS Med 4(3): e103 doi:10.1371/journal.pmed.0040103

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Link Between Serum Vit D & Heart Disease Risk

Levels of serum 25-OH D & CVD risk examined in 15,088 individuals age >20 7,186 men / 7,902 women versampling of blacks, Hispanics & individuals aged > 60 Mean 25-OH D level = 30 ng/mL. Levels lower in women, older individuals,

ethnic minorities, obese subjects & those with HTN or DM OR of CVD comparing those w/ serum OH 25 D in lowest (<21) vs highest (>37) quartiles:

– HTN: 1.30 – DM: 1.98 – Obesity: 2.28 – High serum triglyceride: 1.47 Good safety at doses of 2000-3000 IU per day Vit D level < 21 assoc w/ immunological abnormalities, HTN & CHF Author emphasized that 2000 IU/day is more likely to achieve adequate blood

levels of Vit D for prevention of CVD & that there is compelling evidence that it reduces inflammation, lowers renin & angiotensin, may lower BP or blood vessel proliferation and may improve insulin sensitivity!

Norris, et al. Archives of Internal Medicine; June 11, 2007

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Calcium

CaCa++++ should still be given at doses of 1000-1500 mg qd should still be given at doses of 1000-1500 mg qd as multiple dosesas multiple doses ––> never more than 500-600 mg at a time because people can’t > never more than 500-600 mg at a time because people can’t absorb more from a single doseabsorb more from a single dose

May give Ca++ with or without Vit D, as safety profile May give Ca++ with or without Vit D, as safety profile shows that the additional D2 will not cause harm shows that the additional D2 will not cause harm ((Norris study recommended 2000 IU / d or 60,000 IU q moNorris study recommended 2000 IU / d or 60,000 IU q mo))

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Conclusions

1. Falls are bad2. Hip Fractures are worse3. We can have an immediate & long term impact with

very little cost or effort4. Every patient should be on the equivalent of ±1000-

1500 IU of Vitamin D3 daily, given most easily as: 50,000 units monthly, or 10,000 units (2 x 5000 u caps) weekly

5. Every patient possible should be in GOOD Hip Protectors (eg, FallGard)

6. Continue Ca++ supplements at 500 mg bid - tid

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Obtaining Vitamin D3

1.1. OTC? I’m still researching this…OTC? I’m still researching this…

2.2. Biotech-PharmacalBiotech-Pharmacal 50,000 IU capsule50,000 IU capsule

NDC # 53191-362-01 (Product ID 362A)NDC # 53191-362-01 (Product ID 362A) Bottles of 100 by prescription only for Bottles of 100 by prescription only for $15$15

5000 IU capsule5000 IU capsule NDC # 53191-244-50 (Product ID 2445000A)NDC # 53191-244-50 (Product ID 2445000A) Bottles of 250 by prescription only forBottles of 250 by prescription only for $7.85$7.85

Contact Brad SmithContact Brad Smith 1-800-345-11991-800-345-1199 Fax: 479-443-5643Fax: 479-443-5643 Brad@bio-tech-pharm.com Cardinal will drop ship the item, but you'll have to speak with a representative and

tell them you need to have it "drop shipped from “Biotech-Pharmacal"

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Vitamin D3 to reduce falls and Fractures References

Bischoff-Ferrari HA. Effect of vitamin D on falls: a meta-analysis. JAMA. 2004;291:1999-2006.Bischoff-Ferrari HA. Fracture Prevention With Vitamin D,A Meta-analysis JAMA. 2005;293:2257-2264.Sambrook PN, et al. Vitamin D deficiency is common in frail institutionalised older people in northern Sydney. Med J

Aust 2002; 176:560Le Boff MS. Occult vitamin D deficiency in postmenopausal US women with acute hip fracture. JAMA 1999;

281:1505–11. Harwood RH, et al. A randomized, controlled comparison of different calcium & vitamin D supplementation regimens

in elderly women after hip fracture: the Nottingham Neck of Femur Study (NoNOF). Age Ageing 2004; 33:45–51.Semba RD. Vitamin D deficiency among older women with and without disability. Am J Clin Nutr 2000; 72:1529–34.Flicker L. Serum vitamin D & falls in older women in residential care in Australia. J Am Geriatr Soc 2003; 51:1533–8.Sahota O, Masud T, San P, Hosking DJ. Vitamin D insufficiency increases bone turnover markers and enhances

bone loss at the hip in patients with established vertebral osteoporosis. Clin Endocrinol (Oxf ) 1999; 51:217–21. Morris A, Nordin BEC. Relationship between serum hydroxyvitamin D and bone resorption markers in vitamin D

insufficiency. Bone 2002; 31:626–30.Vieth R. Vitamin D supplementation, 25-hydroxyvitamin D concentrations, and safety. Am J Clin Nutr 1999;69:842–56Heaney R Symposium: Optimizing Vitamin D Intake for Populations with Special Needs: Barriers to Effective Food

Fortification & Supplementation Barriers to Optimizing Vitamin D3 Intake for the Elderly; J. Nutr. 136:1123-1125, April 2006

Bischoff-Ferrar HA. Higher 25-hydroxyvitamin D concentrations are associated with better lower-extremity function in both active and inactive persons aged 60 y. Am J Clin Nutr 2004;80:752–8.

NIH Web Site for Vitamin D recommendations : http://ods.od.nih.gov/factsheets/vitamind.aspBio-Tech Pharmacal Web site www.bio-tech-pharm.com/products/d35.html