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Risedronate for prevention of bone mineral density loss in patients receiving high-dose glucocorticoids: a randomized double-blind placebo-controlled trial

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Abstract

Summary

This 6-month randomized double-blind placebo-controlled trial shows that risedronate is well tolerated and effective in improving lumbar spine BMD and reducing loss of BMD at the hips in patients receiving high-dose prednisolone.

Introduction

Bisphosphonates have proven benefits in patients receiving chronic low-dose glucocorticoids. However, whether they are effective in preventing bone mineral density (BMD) loss during periods of high-dose glucocorticoid treatment is unclear. The objective of this paper is to study the efficacy of risedronate in preventing bone mineral density (BMD) loss in users of high-dose glucocorticoids.

Methods

Adult patients with medical diseases treated with high-dose prednisolone (>0.5 mg/kg/day) were randomized to receive risedronate (5 mg/day) or placebo for 6 months in a double-blind manner, along with elemental calcium (1,000 mg/day). Changes in BMD were studied.

Results

One hundred and twenty patients were recruited (82 women, age 42.8 ± 14.3 years, 63% corticosteroid-naive, 30% women postmenopausal) and 103 completed the study. Baseline clinical characteristics and BMD were similar in the risedronate and placebo groups. At 6 months, a significant gain in spinal BMD was observed in the risedronate group (+0.7 ± 0.3%; p = 0.03) but a drop was detected in the placebo group (−0.7 ± 0.4%; p = 0.12). After adjustment for baseline BMD, age, gender, body mass index and cumulative prednisolone dosages, the inter-group difference in spinal BMD remained significant (1.4%; p = 0.006). Both groups had a significant drop in hip BMD, but the magnitude was greater in the placebo arm (−0.8 ± 0.4% in risedronate versus −1.3 ± 0.5% the in placebo). No new fractures developed. Subgroup analysis of corticosteroid-naive patients yielded similar results. Upper gastrointestinal adverse events were numerically more frequent in the risedronate group.

Conclusions

Risedronate improves spinal BMD in users of high-dose glucocorticoids.

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Acknowledgement

The risedronate and placebo drug samples were provided free of charge from Sanofi-Aventis. Apart from drug samples, there was no other financial subsidy from the drug company. None of the authors have financial interests with Sanofi-Aventis.

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Authors and Affiliations

  1. Department of Medicine and Nuclear Medicine, Tuen Mun Hospital, Tuen Mun, Hong Kong

    C. C. Mok, K. H. Tong, C. H. To, Y. P. Siu & K. M. Ma

  2. Department of Medicine, Tuen Mun Hospital, Tsing Chung Koon Road, New Territories, Hong Kong, SAR, China

    C. C. Mok

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  1. C. C. Mok
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  2. K. H. Tong
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  3. C. H. To
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  4. Y. P. Siu
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Correspondence to C. C. Mok.

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Mok, C.C., Tong, K.H., To, C.H. et al. Risedronate for prevention of bone mineral density loss in patients receiving high-dose glucocorticoids: a randomized double-blind placebo-controlled trial. Osteoporos Int 19, 357–364 (2008). https://doi.org/10.1007/s00198-007-0505-y

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  • DOI: https://doi.org/10.1007/s00198-007-0505-y

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