Postmenopausal Osteoporosis Clinical Trial
— FACTOfficial 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
Verified date | April 2024 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1053 |
Est. completion date | April 1, 2004 |
Est. primary completion date | April 1, 2004 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
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. Erratum In: J Clin Endocrinol Metab. 2007 Aug;92(8):3032. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: Curr Med Res Opin. 2005 Feb;21(2):325. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months | Baseline and 12 months | ||
Primary | Mean percent change from baseline in hip trochanter BMD at 24 months | Baseline and 24 months | ||
Secondary | Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months | Baseline and 12 months | ||
Secondary | Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months | Baseline and 24 months | ||
Secondary | Change from baseline in biochemical markers of bone turnover at 12 months | Baseline and 12 months | ||
Secondary | Change from baseline in biochemical markers of bone turnover at 24 months | Baseline and 24 months | ||
Secondary | Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months | 12 months | ||
Secondary | Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months | 24 months | ||
Secondary | Number of participants who experienced one or more adverse events (AE) | Up to 24 months | ||
Secondary | Number of participants who discontinued study medication due to an AE | Up to 24 months |
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