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

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ClinicalTrials.gov Identifier: NCT00168909
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 9, 2008
Sponsor:
Information provided by:
Charite University, Berlin, Germany

Brief 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)


Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Osteopenia Falls Drug: alfacalcidol Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2003
Actual Primary Completion Date : July 2007
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls
U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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)
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008

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

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