once-monthly ibandronate

1
Treat Endocrinol 2005; 4 (6): 389-390 GUEST COMMENTARIES 1175-6349/05/0006-0389/$34.95/0 © 2005 Adis Data Information BV. All rights reserved. fracture risk was seen in the BONE (oral iBandronate Osteo- Once-Monthly Ibandronate porosis vertebral fracture trial in North America and Europe) study A Viewpoint by Stuart Silverman cohort. However, in patients at high risk of non-vertebral fracture, Cedars-Sinai/University of California, Los Angeles, Beverly with T-scores in the femoral neck of less than 3, there was a Hills, California, USA significant reduction in non-vertebral fracture risk. In a non- inferiority study, monthly ibandronate 150mg provided equivalent Bisphosphonates are the current mainstay of therapy used in BMD increases and bone marker decreases to the approved daily osteoporosis management. Until recently the approved bisphos- dose, with superior BMD increases at the spine and hip. Oral once- phonates (alendronate and risedronate) were taken either daily or monthly ibandronate was generally well tolerated; the incidence of weekly and were accompanied with a need for a 30-minute post- adverse events did not differ significantly between once-monthly dose fast. Bisphosphonates are effective in increasing bone miner- and once-daily ibandronate. al density (BMD) and reducing bone turnover, effectively reduc- The once-monthly administration of oral ibandronate offers an ing vertebral fracture risk by 40–50% in randomized controlled alternative option to healthcare providers and patients. Patients trials. Non-vertebral fracture reduction has been harder to demon- have indicated a preference for monthly versus weekly dosing. [4] strate. Alendronate is indicated for hip fracture reduction and Those taking ibandronate will be offered assistance in adherence risedronate is indicated for reduction of a composite endpoint of through a patient support program. Further research is needed to non-vertebral fracture. document if there is an improvement in patient adherence with Despite the proven efficacy of bisphosphonates, patient adher- monthly dosing. ence to bisphosphonates has been suboptimal. [1] Twelve-month persistence rates measured by pharmacy claims data were 19–33% for daily therapy and 44–55% for weekly. [1,2] The consequences of References poor adherence include smaller changes in BMD and bone turn- 1. Recker RR, Gallagher R, MacCosbe PE. Effect of dosing frequency on bisphos- over markers, with a subsequent decrease in fracture risk reduc- phonate medication adherence in a large longitudinal cohort of women. Mayo tion, both vertebral and non-vertebral. In one study, if patients Clin Proc 2005; 80: 856-61 were >80% refill compliant, the vertebral fracture risk was re- 2. Cramer JA, Amonker MM, Hebborn A, et al. Compliance and persistence with duced by 26%. [3] bisphosphonate dosing regimens among women with postmenopausal osteo- porosis. Curr Med Res Opin. In press Ibandronate is a newly-approved, nitrogen-containing bisphos- 3. Siris ES, Rosen CJ, Harris ST, et al. Adherence rates to bisphosphonate therapy: phonate that requires once-monthly administration with a 60- relationship to bone fractures at 24 months in women with postmenopausal minute, post-dose fast. Animal data suggest that the efficacy of the osteoporosis [abstract no. 397]. The Sixth International Symposium on Osteo- porosis: Current Status and Future Directions, the National Osteoporosis Foun- drug is determined by the cumulative dose rather than the frequen- dation; 2005 Apr 6–10; Washington (DC) cy of administration. Ibandronate at a daily dose of 2.5mg reduced 4. Simon JA, Beusterien KM, Hebborn A, et al. Bisphosphonate dosing preferences in vertebral fracture risk by 52% and clinical vertebral fracture risk women with postmenopausal osteoporosis: a study. The Female Patient 2004; 30: 31-6 by 48% at 3 years. No significant reduction in non-vertebral

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Page 1: Once-Monthly Ibandronate

Treat Endocrinol 2005; 4 (6): 389-390GUEST COMMENTARIES 1175-6349/05/0006-0389/$34.95/0

© 2005 Adis Data Information BV. All rights reserved.

fracture risk was seen in the BONE (oral iBandronate Osteo-Once-Monthly Ibandronate porosis vertebral fracture trial in North America and Europe) studyA Viewpoint by Stuart Silvermancohort. However, in patients at high risk of non-vertebral fracture,

Cedars-Sinai/University of California, Los Angeles, Beverly with T-scores in the femoral neck of less than –3, there was aHills, California, USA

significant reduction in non-vertebral fracture risk. In a non-

inferiority study, monthly ibandronate 150mg provided equivalentBisphosphonates are the current mainstay of therapy used in BMD increases and bone marker decreases to the approved daily

osteoporosis management. Until recently the approved bisphos- dose, with superior BMD increases at the spine and hip. Oral once-phonates (alendronate and risedronate) were taken either daily or monthly ibandronate was generally well tolerated; the incidence ofweekly and were accompanied with a need for a 30-minute post- adverse events did not differ significantly between once-monthlydose fast. Bisphosphonates are effective in increasing bone miner- and once-daily ibandronate.al density (BMD) and reducing bone turnover, effectively reduc-

The once-monthly administration of oral ibandronate offers aning vertebral fracture risk by 40–50% in randomized controlled

alternative option to healthcare providers and patients. Patientstrials. Non-vertebral fracture reduction has been harder to demon-

have indicated a preference for monthly versus weekly dosing.[4]strate. Alendronate is indicated for hip fracture reduction and

Those taking ibandronate will be offered assistance in adherencerisedronate is indicated for reduction of a composite endpoint ofthrough a patient support program. Further research is needed tonon-vertebral fracture.document if there is an improvement in patient adherence with

Despite the proven efficacy of bisphosphonates, patient adher-monthly dosing. ▲

ence to bisphosphonates has been suboptimal.[1] Twelve-monthpersistence rates measured by pharmacy claims data were 19–33%for daily therapy and 44–55% for weekly.[1,2] The consequences of

Referencespoor adherence include smaller changes in BMD and bone turn-1. Recker RR, Gallagher R, MacCosbe PE. Effect of dosing frequency on bisphos-over markers, with a subsequent decrease in fracture risk reduc-

phonate medication adherence in a large longitudinal cohort of women. Mayotion, both vertebral and non-vertebral. In one study, if patients Clin Proc 2005; 80: 856-61

were >80% refill compliant, the vertebral fracture risk was re- 2. Cramer JA, Amonker MM, Hebborn A, et al. Compliance and persistence withduced by 26%.[3] bisphosphonate dosing regimens among women with postmenopausal osteo-

porosis. Curr Med Res Opin. In pressIbandronate is a newly-approved, nitrogen-containing bisphos-

3. Siris ES, Rosen CJ, Harris ST, et al. Adherence rates to bisphosphonate therapy:phonate that requires once-monthly administration with a 60-relationship to bone fractures at 24 months in women with postmenopausal

minute, post-dose fast. Animal data suggest that the efficacy of the osteoporosis [abstract no. 397]. The Sixth International Symposium on Osteo-porosis: Current Status and Future Directions, the National Osteoporosis Foun-drug is determined by the cumulative dose rather than the frequen-dation; 2005 Apr 6–10; Washington (DC)

cy of administration. Ibandronate at a daily dose of 2.5mg reduced4. Simon JA, Beusterien KM, Hebborn A, et al. Bisphosphonate dosing preferences in

vertebral fracture risk by 52% and clinical vertebral fracture risk women with postmenopausal osteoporosis: a study. The Female Patient 2004;30: 31-6by 48% at 3 years. No significant reduction in non-vertebral