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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_016 | Other Identifier | Protocol number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alendronate 70 mg | Experimental | Alendronate sodium, 70 mg, orally once weekly for up to 24 months |
|
| Risendronate 35 mg | Active Comparator | Risendronate, 35 mg, orally once weekly for up to 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate | Drug | Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months | Baseline and 12 months | |
| Mean percent change from baseline in hip trochanter BMD at 24 months | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months | Baseline and 12 months | |
| Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months | Baseline and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15619680 | 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. | |
| 15706659 |
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|
| Risedronate 35 mg | Drug | Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose. |
|
|
| Elemental Calcium | Dietary Supplement | Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose. |
|
| Vitamin D | Dietary Supplement | Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose. |
|
| Risendronate placebo | Drug | Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose. |
|
| Alendronate placebo | Drug | Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose. |
|
| Change from baseline in biochemical markers of bone turnover at 12 months | Baseline and 12 months |
| Change from baseline in biochemical markers of bone turnover at 24 months | Baseline and 24 months |
| Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months | 12 months |
| Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months | 24 months |
| Number of participants who experienced one or more adverse events (AE) | Up to 24 months |
| Number of participants who discontinued study medication due to an AE | Up to 24 months |
| 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. |
| 16636120 | 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. |
| 19141590 | 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. |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| D000068296 | Risedronic Acid |
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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