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Changes in 25-Hydroxyvitamin D3 to oral treatment with vitamin D3 in postmenopausal females with osteoporosis

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Abstract

Summary

This study reports on oral treatment with different doses of vitamin D3 ranging from 25 to 200 µg in females with 25-hydroxyvitamin D3 levels < 60 nmol/L screened for participation in an osteoporosis trial. A guidance to safely and efficiently achieve 25-hydroxyvitamin D3 levels > 60 nmol/L is presented.

Introduction

The importance of vitamin D for skeletal health has been implemented in clinical trials in osteoporosis. The threshold of 25-hydroxyvitamin D for inclusion has changed from 30 to 60 nmol/L. This study reports on oral treatment with different doses of vitamin D3 in females with 25-hydroxyvitamin D3 levels < 60 nmol/L.

Methods

In 131 postmenopausal females screened for participation in an osteoporosis trial, the 25-hydroxyvitamin D3 concentration was < 60 nmol/L. They were treated with 25 (n = 22), 50 (n = 19), 75 (n = 19), 100 (n = 41) or 200 μg (n = 30) of vitamin D3 daily for at least 10 days.

Results

In the females treated with 25, 50, 75, 100 and 200 μg of vitamin D3 daily the 25-hydroxyvitamin D3 concentrations increased significantly from 32.4 ± 2.7 (mean ± SEM) to 50.8 ± 2.9, from 46.7 ± 2.8 to 65.8 ± 2.6, from 41.6 ± 2.7 to 67.4 ± 2.9, from 46.7 ± 1.4 to 64.4 ± 2.2 and from 42.1 ± 2.0 to 71.2 ± 2.8 nmol/L, respectively (p < 0.001). S-calcium increased significantly but within the reference range (p < 0.006).

Conclusion

Oral vitamin D3 safely increased 25-hydroxyvitamin D3 concentrations in all females above 60 nmol/L. This study demonstrates how to achieve the new recommended 25-hydroxyvitamin D concentrations within the screening period of a clinical trial.

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Acknowledgement

We are indebted to Mrs. Lene Ulrichsen for help in the collection of the data.

Conflicts of interest

Hans C. Hoeck: employed by CCBR (Center for Clinical & Basic research), a private research company engaged in contract research with various pharmaceutical and biotech companies. Bo Li and Per Qvist: employed by Nordic Bioscience, a privately owned biotech company based in Denmark and engaged in medical research.

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Authors and Affiliations

  1. CCBR (Center for Clinical and Basic Research), Hobrovej 42 D, 2, 9000, Aalborg, Denmark

    H. C. Hoeck

  2. Nordic Bioscience A/S, Herlev, Denmark

    B. Li & P. Qvist

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  1. H. C. Hoeck
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  2. B. Li
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  3. P. Qvist
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Correspondence to H. C. Hoeck.

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Hoeck, H.C., Li, B. & Qvist, P. Changes in 25-Hydroxyvitamin D3 to oral treatment with vitamin D3 in postmenopausal females with osteoporosis. Osteoporos Int 20, 1329–1335 (2009). https://doi.org/10.1007/s00198-008-0790-0

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  • DOI: https://doi.org/10.1007/s00198-008-0790-0

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