To Test the Effect of Calcifediol Hy.D Supplementation on Muscle Function and Bone Quality in Younger Postmenopausal Women With Osteopenia: a Double-blind Randomized Placebo-controlled Trial
Abstract
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.
Conditions: Osteopenia/Osteoporosis.
Primary outcome: 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).
Enrollment: 150 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 150 participants or records.
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