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

Summary

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.

Timeline

Start

2002-09-01

Primary completion

2004-04-01

Completion

2004-04-01

Publications

• Background 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. doi: 10.1359/JBMR.040920. Epub 2004 Sep 29.
• Background 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. doi: 10.1185/030079904x16768.
• Background 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. doi: 10.1210/jc.2005-2602. Epub 2006 Apr 24.
• Background 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.

Drugs

Indications