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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
282
alfacalcidol 1 µg once daily, oral, for 3 years
placebo once daily, oral, for 3 years
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, Germany
Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen
Stuttgart, Germany
primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)
Time frame: 3 years
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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