Long-Term Treatment and Effect of Discontinuation of Calcifediol in Postmenopausal Women with Vitamin D Deficiency: A Randomized Trial
Authors' conclusion
The results confirm that long-term treatment with monthly calcifediol in vitamin D-deficient patients is effective and safe. The withdrawal of treatment leads to a pronounced decrease of 25(OH)D levels. Calcifediol presented a faster onset of action compared to monthly cholecalciferol. Long-term treatment produces stable and sustained 25(OH)D concentrations with no associated safety concerns.
Study context
- Population
- Postmenopausal women with vitamin D deficiency (25(OH)D < 20 ng/mL)298 evaluated
- Participants
- 303 women
- Comparison
- Monthly calcifediol 0.266 mg vs cholecalciferol 25,000 IU
Methodological detailsphase III-IV, double-blind, parallel, multicentre, superiority
- Phase III-IV
- Double-blind
- Parallel
- Multicentre
- Superiority
Primary result
As reported in the abstract
25(OH)D levels · month 4
Further findings
| Outcome | Group A1 | Group B |
|---|---|---|
| 25(OH)D levels · month 12 | 23.9 ± 8.0 ng/mL | 22.4 ± 5.5 ng/mL |
25(OH)D after calcifediol withdrawal (Group A2) · month 4 vs month 12
- Group A2 25(OH)D at month 4
- 28.5 ± 8.7 ng/mL
- Group A2 25(OH)D at month 12 (decreased to baseline levels)
- 14.4 ± 6.0 ng/mL
Safety
- No relevant treatment-related safety issues reported in any of the groups
Original publication
Long-Term Treatment and Effect of Discontinuation of Calcifediol in Postmenopausal Women with Vitamin D Deficiency: A Randomized Trial. J Bone Miner Res. Published 20 January 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →