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

Last updated: August 12, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Osteoporosis

Post-menopausal Osteopenia

Treatment

Alendronate

Risendronate placebo

Alendronate placebo

Clinical Study ID

NCT00092014
0217-211
2004_016
  • Ages > 25
  • Female

Study 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

Inclusion Criteria:

  • Women with postmenopausal osteoporosis

Exclusion

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

Total Participants: 1053
Treatment Group(s): 6
Primary Treatment: Alendronate
Phase: 3
Study Start date:
September 01, 2002
Estimated Completion Date:
April 01, 2004