Status:
COMPLETED
Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Osteoporosis, Postmenopausal
Osteopenia
Eligibility:
FEMALE
65+ years
Phase:
PHASE4
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 = num...
Eligibility Criteria
Inclusion
- age \> 65 years
- postmenopausal women
- osteopenia/osteoporosis as defined by WHO criteria
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00168909
Start Date
June 1 2003
End Date
May 1 2008
Last Update
May 9 2008
Active Locations (2)
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1
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, Germany, 12200
2
Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen
Stuttgart, Germany, 73732