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

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Risedronate 35 mg; Drug: Alendronate; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D; Drug: Alendronate placebo; Drug: Risendronate placebo

• Registration Number: NCT00092014
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09-01
• Primary Completion: 2004-04-01
• Study Completion: 2004-04-01
• Study First Submitted: 2004-09-21
• Study First Submitted QC: 2004-09-23
• Study First Posted: 2004-09-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1053

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alendronate 70 mg	Vitamin D	Alendronate sodium, 70 mg, orally once weekly for up to 24 months
Risendronate 35 mg	Alendronate placebo	Risendronate, 35 mg, orally once weekly for up to 24 months
Risendronate 35 mg	Elemental Calcium	Risendronate, 35 mg, orally once weekly for up to 24 months
Alendronate 70 mg	Elemental Calcium	Alendronate sodium, 70 mg, orally once weekly for up to 24 months
Alendronate 70 mg	Risendronate placebo	Alendronate sodium, 70 mg, orally once weekly for up to 24 months
Risendronate 35 mg	Risedronate 35 mg	Risendronate, 35 mg, orally once weekly for up to 24 months
Risendronate 35 mg	Vitamin D	Risendronate, 35 mg, orally once weekly for up to 24 months
Alendronate 70 mg	Alendronate	Alendronate sodium, 70 mg, orally once weekly for up to 24 months

Primary Outcome Measures

Name	Time	Method
Mean percent change from baseline in hip trochanter BMD at 24 months	Baseline and 24 months
Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
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
Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months	Baseline and 12 months
Change from baseline in biochemical markers of bone turnover at 12 months	Baseline and 12 months
Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months	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 24 months	24 months
Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months	Baseline and 24 months