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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Alfacalcidol; Hydroxycholecalciferols

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)