NCT00168909

Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)

Influence of Alfacalcidol on Falls in Elderly Postmenopausal, Alendronate-Treated, Osteopenic/Osteoporotic Women With High Risk of Falls

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women. primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls)

Conditions

• Osteoporosis, Postmenopausal
• Osteopenia
• Falls

Interventions

Type	Name	Description
DRUG	alfacalcidol	alfacalcidol 1 µg once daily, oral, for 3 years
DRUG	placebo	placebo once daily, oral, for 3 years

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-07-01
• Completion: 2008-05-01
• First posted: 2005-09-15
• Last updated: 2008-05-09

Locations

2 sites across 1 country: Germany