NCT00092014

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,053 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Alendronate	Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
DRUG	Risedronate 35 mg	Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
DIETARY_SUPPLEMENT	Elemental Calcium	Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
DIETARY_SUPPLEMENT	Vitamin D	Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
DRUG	Risendronate placebo	Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
DRUG	Alendronate placebo	Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Timeline

• Start date: 2002-09-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2004-09-24
• Last updated: 2024-08-14