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

NCT00168909 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2008-05-09

No results posted yet for this study

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

DRUG

alfacalcidol

alfacalcidol 1 µg once daily, oral, for 3 years

DRUG

placebo

placebo once daily, oral, for 3 years

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Dieter Felsenberg, Prof. Dr. · Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2007-07-31
Completion
2008-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00168909 on ClinicalTrials.gov