Clinical trial NCT00092014: A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 1053
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months
timeFrame: Baseline and 12 months
measure: Mean percent change from baseline in hip trochanter BMD at 24 months
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months
timeFrame: Baseline and 12 months
measure: Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in biochemical markers of bone turnover at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in biochemical markers of bone turnover at 24 months
timeFrame: Baseline and 24 months
measure: Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months
timeFrame: 12 months
measure: Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months
timeFrame: 24 months
measure: Number of participants who experienced one or more adverse events (AE)
timeFrame: Up to 24 months
measure: Number of participants who discontinued study medication due to an AE
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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.