Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2025
Effect of calcifediol and cholecalciferol on muscle function in postmenopausal women: a randomized controlled trial.
Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02527668 (To Test the Effect of Calcifediol Hy.D Supplementation on Muscle Function and Bone Quality in Younger Postmenopausal Women With Osteopenia), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Brief rationale: Limited evidence exists on calcifediol's effect on lower extremity function in postmenopausal women with osteoporosis or osteopenia. MAIN
resultCalcifediol (20 µg/day) showed no greater benefit than vitamin D3 (3200 IU/day) or placebo. Significance of the paper: Findings do not support high-dose vitamin D3 or calcifediol for improving lower extremity function. PURPOSE: To test the effect of 20 µg/day of calcifediol compared with 3200 IU/day of vitamin D3 and placebo on lower extremity function in postmenopausal women with osteopenia or osteoporosis.
methodsThis is a 3-arm double-blind RCT among postmenopausal women aged 50-70 years with serum 25(OH)D < 30 ng/mL, and a DXA-based diagnosis of osteopenia or osteoporosis. Participants were randomized to receive either daily 20 µg calcifediol, daily 3200 IU vitamin D3, or placebo. The primary endpoint was a composite measure of lower extremity function, assessed at baseline, 3, and 6 months, including four tests: gait speed, knee flexor and extensor strength, and repeated sit-to-stand test. The primary endpoint was the probability of success (improvement or maintenance from baseline) in any of the eight tests, four tests at 3 months and four tests at 6 months.
resultsThe trial enrolled 152 women (mean age, 61.0 years; mean serum 25(OH)D level, 23.4 ng/mL), and all but one woman completed all follow-up visits. Baseline characteristics, including the four tests of lower extremity function, were balanced across the three groups. The adjusted probability of success in any of the eight tests was 53.6% (95% confidence interval 47%, 60%) with calcifediol, 55.5% (50%, 61%) with vitamin D3, and 61.4% (55%, 67%) with placebo, without significant differences between treatment groups.
conclusionsOur findings do not support supplementation with daily calcifediol or equivalent high-dose daily vitamin D3 for improving or maintaining lower extremity function among younger postmenopausal women (age 50-70) with osteopenia or osteoporosis, who were pre-selected for vitamin D insufficiency or deficiency (25(OH)D < 30 ng/mL; baseline mean 25(OH)D 23.4 ng/mL).
trial registrationClinicaltrials.gov; NCT02527668; https://clinicaltrials.gov/ct2/show/NCT02527668.
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