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

May 8, 2008 updated by: Charite University, Berlin, Germany

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
      • Stuttgart, Germany, 73732
        • Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age > 65 years
  • postmenopausal women
  • osteopenia/osteoporosis as defined by WHO criteria

Exclusion Criteria:

  • Neoplasm or other severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
  • Chronic inflammatory rheumatoid disease
  • Arthritis with continuous pain and influence on locomotion
  • Inflammatory or metabolic bone disease, excluding osteoporosis.
  • Subjects with antiosteoporotic medications who are not willing to switch over to alendronate treatment. Estrogen treatment can be continued
  • 25-OH-Vitamin D3 < 12 ng/ml (12 ng/ml = 30 mmol/L)
  • Systemic corticosteroid treatments of more than one month within previous 12 months
  • Intolerability for alfacalcidol
  • Hypercalcaemia (>2,7 mmol/l)
  • Milk alkali syndrome
  • Uncorrected, severe visual impairments
  • Creatinin > 2.5 mg/dl (>220 µmol/L)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
placebo
Drug: placebo
placebo once daily, oral, for 3 years
Experimental: 1
alfacalcidol 1µg/d
Drug: alfacalcidol
alfacalcidol 1 µg once daily, oral, for 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
secondary outcome: number of falls (locomotor falls, incl.mixed falls), all falls/fallers, neuromuscular parameters, BMD, biochemical parameters of calcium and bone metabolism; cognition and moods; muscle biopsies
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2008

Last Update Submitted That Met QC Criteria

May 8, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ek.213-07 (IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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