A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)

Condition(s) targeted: Postmenopausal Osteoporosis

Intervention: Alendronate (Drug); Risedronate 35 mg (Drug); Elemental Calcium (Dietary Supplement); Vitamin D (Dietary Supplement); Risendronate placebo (Drug); Alendronate placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

This study is to evaluate and compare the effects of Alendronate and Risedronate to treat women with postmenopausal osteoporosis. The primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline in hip trochanter bone mineral density (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg once weekly.

Official title: A 12-Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Once Weekly Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months

Mean percent change from baseline in hip trochanter BMD at 24 months

Secondary outcome:

Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months

Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months

Change from baseline in biochemical markers of bone turnover at 12 months

Change from baseline in biochemical markers of bone turnover at 24 months

Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months

Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months

Number of participants who experienced one or more adverse events (AE)

Number of participants who discontinued study medication due to an AE

Minimum age: 25 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women with postmenopausal osteoporosis

Exclusion Criteria:

- Bilateral hip replacements

- Esophageal abnormalities

- Metabolic bone disease (example - Vitamin D deficiency)

- Medications that would affect the breakdown or build-up of bone turnover

Related publications:

Rosen CJ, Hochberg MC, Bonnick SL, McClung M, Miller P, Broy S, Kagan R, Chen E, Petruschke RA, Thompson DE, de Papp AE; Fosamax Actonel Comparison Trial Investigators. Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study. J Bone Miner Res. 2005 Jan;20(1):141-51. Epub 2004 Sep 29.

Sebba AI, Bonnick SL, Kagan R, Thompson DE, Skalky CS, Chen E, de Papp AE; Fosamax Actonel Comparison Trial investigators. Response to therapy with once-weekly alendronate 70 mg compared to once-weekly risedronate 35 mg in the treatment of postmenopausal osteoporosis. Curr Med Res Opin. 2004 Dec;20(12):2031-41. Erratum in: Curr Med Res Opin. 2005 Feb;21(2):325.

Bonnick S, Saag KG, Kiel DP, McClung M, Hochberg M, Burnett SM, Sebba A, Kagan R, Chen E, Thompson DE, de Papp AE. Comparison of weekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years. J Clin Endocrinol Metab. 2006 Jul;91(7):2631-7. Epub 2006 Apr 24. Erratum in: J Clin Endocrinol Metab. 2007 Aug;92(8):3032.

Burnett-Bowie SM, Saag K, Sebba A, de Papp AE, Chen E, Rosenberg E, Greenspan SL. Prediction of changes in bone mineral density in postmenopausal women treated with once-weekly bisphosphonates. J Clin Endocrinol Metab. 2009 Apr;94(4):1097-103. doi: 10.1210/jc.2008-1122. Epub 2009 Jan 13.

Starting date: September 2002
Last updated: December 2, 2013