Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)
NCT ID: NCT00168909
Last Updated: 2008-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
282 participants
INTERVENTIONAL
2003-06-30
2008-05-31
Brief Summary
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primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls)
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
alfacalcidol 1µg/d
alfacalcidol
alfacalcidol 1 µg once daily, oral, for 3 years
2
placebo
placebo
placebo once daily, oral, for 3 years
Interventions
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alfacalcidol
alfacalcidol 1 µg once daily, oral, for 3 years
placebo
placebo once daily, oral, for 3 years
Eligibility Criteria
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Inclusion Criteria
* postmenopausal women
* osteopenia/osteoporosis as defined by WHO criteria
Exclusion Criteria
* 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)
65 Years
FEMALE
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Charité - Campus Benjamin Franklin, Centre for Muscle and Bone Research, Hindenburgdamm 30, 12200 Berlin, Germany
Principal Investigators
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Dieter Felsenberg, Prof. Dr.
Role: STUDY_CHAIR
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, Germany
Locations
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Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, , Germany
Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen
Stuttgart, , Germany
Countries
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Other Identifiers
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ek.213-07 (IRB)
Identifier Type: -
Identifier Source: org_study_id