The effect of high-dose vitamin D on bone mineral density and bone turnover markers in postmenopausal women with low bone mass—a randomized controlled 1-year trial
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Vitamin D is widely used in osteoporosis treatment, although the optimal dose is not known. This 1-year clinical study among 297 women aged 50–80 years old showed that a vitamin D3 dose of 6,500 IU/day was not better than the standard dose of 800 IU/day in improving bone mineral density (BMD) in the hip and spine.
The purpose of this study was to determine whether a high dose of vitamin D3 was better than the standard dose in improving BMD and reducing bone turnover in postmenopausal women with reduced bone mass.
The study was a 1-year randomized double-blind controlled trial comparing high-dose vitamin D3 with the standard dose. Postmenopausal women (n = 297) with a BMD T-score ≤ −2.0 in either lumbar spine (L2–4) or total hip were included and randomized to 6,500 IU vitamin D3/day (20,000 IU twice per week + 800 IU/day) or 800 IU vitamin D3/day (placebo twice per week + 800 IU/day). Both groups were given 1,000 mg elemental calcium/day. The primary endpoint was a change in BMD in total hip and lumbar spine (L2–4).
After 1 year, serum 25-hydroxyvitamin D (25(OH)D) increased [mean (SD)] from 71 (23) to 185 (34) nmol/l and from 71 (22) to 89 (17) nmol/l in the high- and standard-dose vitamin D groups, respectively. BMD at all measurement sites was unchanged or slightly improved with no significant differences between the groups. Although bone turnover was reduced in both groups, the more pronounced reduction in serum levels of the bone formation marker P1NP in the standard-dose group may indicate that this treatment was more efficient. Adverse events did not differ between the groups.
One year treatment with 6,500 IU vitamin D3/day was not better than 800 IU/day regarding BMD in vitamin D-replete postmenopausal women with reduced bone mass and was less efficient in reducing bone turnover.
KeywordsBone mineral density Bone turnover Osteoporosis Postmenopausal women Randomized controlled trial Vitamin D
The study was funded by a grant from The Norwegians Women Public Health Association in Troms. The superb assistance by the staff at the Research Unit, from Marian Remijn and Line Wilsgaard at the DEXA laboratory, Inger Myrnes and Astrid Lindvall at the Department of Medical Biochemistry at the University Hospital of North Norway, Otto Bårholm at the Hormone Laboratory, Haukeland University Hospital, and Anikken Kristiansen and Nina Norstrand at the Hormone Laboratory, Oslo University Hospital is greatly appreciated. We are grateful for the generous supply of Calcigran Forte from Nycomed Norway.
Conflicts of interest
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