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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Alendronate
* Drug: Risedronate 35 mg
* Dietary Supplement: Elemental Calcium
* Dietary Supplement: Vitamin D
* Drug: Risendronate placebo
* Drug: Alendronate placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alendronate 70 mg<br>Alendronate sodium, 70 mg, orally once weekly for up to 24 months | Drug: Alendronate<br>* Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.<br>* Other names: FOSAMAX®;Dietary Supplement: Elemental Calcium<br>* Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.<br>Dietary Supplement: Vitamin D<br>* Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.<br>Drug: Risendronate placebo<br>* Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.<br>|
| Active Comparator: Risendronate 35 mg<br>Risendronate, 35 mg, orally once weekly for up to 24 months | Drug: Risedronate 35 mg<br>* Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.<br>* Other names: Atelvia®;Dietary Supplement: Elemental Calcium<br>* Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.<br>Dietary Supplement: Vitamin D<br>* Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.<br>Drug: Alendronate placebo<br>* Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |