Young postmenopausal women with osteopenia / or women with osteoporosis and a FRAX score below pharmacologic treatment indication have limited treatment options in the prevention of osteoporosis/treatment of osteopenia. Further, there is a concern about long-term side effects of bisphosphonate treatment among young postmenopausal women, and hormone replacement therapy has been controversial. In a pilot study 20 microgram Calcifediol Hy.D improved several muscle related function in this target population within 4 months of treatment, which can help to prevent falls and associated bone fractures. Thus the main aim of this study is to test whether Calcifediol Hy.D at a daily dose of 20 μg / day improves muscle function (lower extremity test battery) compared with (1) placebo and compared with (2) 3200 Vitamin D3 IU per day, at 3 and 6 month follow-up. As a secondary and exploratory objective of this study, the investigators will compare the beforementioned doses on muscle strength and the quality of the bones, beside muscle mass, body composition and systolic and diastolic blood pressure measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
150
One capsule orally of Calcifediol (20 µg) per day with a meal for a duration of 6 months
One capsule orally of Cholecalciferol (3200 IU) per day with a meal for a duration of 6 months
One capsule orally of a Placebo capsule per day with a meal for a duration of 6 months
Center on Aging and Mobility, Klinik für Geriatrie, UniversitätsSpital Zürich
Zurich, Switzerland
Overall assessment of the "lower extremity function" test battery (difference in proportion of those who improved or maintained function compared to those who declined in function by treatment group)
The "lower extremity function" test battery consists of: 8-meter walk test, repeated sit-to-stand test and knee flexion and extension strength test). A repeated measures analysis across all four test battery components simultaneously documenting the difference in proportion of those who improved or maintained function compared to those who declined in function by treatment group (comprised endpoint on lower extremity function) will be performed. Calcifediol Hy.D will be compared with (1) placebo and compared with (2) 3200 Vitamin D3 IU per day -for the time points baseline 3 and 6 months. Outcomes of the individual tests are subject to the secondary outcome measures.
Time frame: Baseline, 3 months, 6 months
Gait speed measurement (8-meter walk)
Time frame: Baseline, 3 months, 6 months
Knee flexion and extension strength test
Time frame: Baseline, 3 months, 6 months
Repeated sit-to-stand test (reaction time)
Time frame: Baseline, 3 months, 6 months
Systolic and diastolic blood pressure
Time frame: Baseline, 3 months, 6 months
Timed up and go test (functional mobility)
Time frame: Baseline, 3 months, 6 months
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