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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00168909
First received: September 9, 2005
Last updated: May 8, 2008
Last verified: May 2008
History of Changes
  Purpose

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)


Condition Intervention Phase
Osteoporosis, Postmenopausal
Osteopenia
Falls
 Drug: alfacalcidol
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Alfacalcidol on Falls in Elderly Postmenopausal, Alendronate-Treated, Osteopenic/Osteoporotic Women With High Risk of Falls

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 282
Study Start Date: June 2003
Study Completion Date: May 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
alfacalcidol 1µg/d
 Drug: alfacalcidol
alfacalcidol 1 µg once daily, oral, for 3 years
Placebo Comparator: 2
placebo
 Drug: placebo
placebo once daily, oral, for 3 years

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168909

Locations
Germany
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, Germany, 12200
Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen
Stuttgart, Germany, 73732
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Chair: Dieter Felsenberg, Prof. Dr. Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. Dieter Felsenberg, Charité - Campus Benjamin Franklin, Centre for Muscle and Bone Research, Hindenburgdamm 30, 12200 Berlin, Germany
ClinicalTrials.gov Identifier: NCT00168909     History of Changes
Other Study ID Numbers: ek.213-07 (IRB)
Study First Received: September 9, 2005
Last Updated: May 8, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
osteoporosis
frailty
falls

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Musculoskeletal Diseases
Hydroxycholecalciferols
1-hydroxycholecalciferol
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 23, 2013