NCT00504166

Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women

Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the changes in bone structure as determined by magnetic resonance imaging measurements among early postmenopausal women after 24 months of treatment with alendronate, 70 mg once a week as compared to placebo

Detailed description

This is a randomized, double-blind, 24-month study. Fifty-five postmenopausal women, age range of 45-65 years, with low bone density will be recruited, with half of the subjects receiving alendronate + 2800 IU of vitamin D once weekly, the other half receiving placebo + 2800 IU of vitamin D once weekly. All study subjects will receive supplemental calcium 1000 mg/day + Vitamin D 400 IU/day. Measurements of microarchitecture will be made in the wrist, ankle, and hip, and the changes in trabecular bone will be assessed at 0, 12 and 24 months. Markers of bone turnover and bone mineral density (BMD) will be used to characterize the cohort and postmenopausal changes in bone turnover and density.

Conditions

• Osteopenia
• Osteoporosis

Interventions

Type	Name	Description
DRUG	alendronate sodium	alendronate sodium 70 mg tablet once week for 24 months
OTHER	placebo comparator	placebo to match alendronate sodium one tablet once a week for 24 months

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2007-07-19
• Last updated: 2013-08-14
• Results posted: 2011-08-10

Locations

1 site across 1 country: United States