Risedronate (Actonel and Actonel Once-a-Week) for corticosteroid-induced osteoporosis Risedronate (Actonel and Actonel Once-a-Week) for corticosteroid-induced osteoporosis

The PBS listing for risedronate (Actonel and Actonel Once-a-Week) and risedronate with calcium (Actonel Combi) has been extended to people with corticosteroid-induced osteoporosis (CIO) who are on long-term high-dose corticosteroid therapy. Eligible people must have been taking high-dose corticosteroids (≥ 7.5 mg/day prednisolone or equivalent) for at least 3 months and have a bone mineral density (BMD) T-score of ≤ –1.5.

Bone loss is worst in the first year of corticosteroid therapy.^1,2 To minimise bone loss, use the smallest possible dose of corticosteroid for the shortest possible time.^1,2 Prescribe at least 1000 mg calcium daily and ensure adequate vitamin D intake.³

The risk of a vertebral or hip fracture increases rapidly after beginning corticosteroid treatment but declines within a year of stopping therapy.^1,2

Limited data on fracture prevention in people with corticosteroid-induced osteoporosis

No trial in people with corticosteroid-induced osteoporosis has used fracture as a primary endpoint or reported a significant reduction in incident fracture among people taking risedronate, compared with placebo.^4–7 However, meta-analysis of fracture data shows a significant decrease in vertebral fracture risk (relative risk 0.33, 95% confidence interval 0.14 to 0.80) among people with corticosteroid-induced osteoporosis taking risedronate 5 mg daily.⁸ There was no significant reduction in vertebral fracture risk among people taking risedronate 2.5 mg daily or in non-vertebral fracture risk in people taking either 2.5 mg or 5 mg daily.⁸

Risedronate can maintain or improve BMD in people using corticosteroids

In clinical trials, BMD levels deteriorated among people taking placebo but remained steady, or occasionally improved, among those taking risedronate 2.5 mg or 5.0 mg.^4–7People taking risedronate 5 mg appear to be more likely to have significantly higher BMD values than those on risedronate 2.5 mg or placebo.^4–7

One trial followed women taking risedronate 2.5 mg daily for 2 years. Women taking risedronate had significantly higher lumbar spine and femoral trochanter BMD than those receiving placebo. A year after stopping therapy, the risedronate group still had significantly higher lumbar spine BMD than the placebo group, but femoral trochanter BMD was similar to that in the placebo group.⁵

Minimise gastrointestinal effects with correct administration

Instruct patients to take risedronate early in the morning on an empty stomach. They should swallow the risedronate tablet whole with a full glass of water and remain upright for 30 minutes after the dose to minimise adverse gastrointestinal effects.³

References

1. Romas E. Corticosteroid-induced osteoporosis and fractures. Australian Prescriber 2008;31:45–9. http://www.australianprescriber.com/magazine/31/2/45/9/
2. Royal College of Physicians, Bone and Tooth Society of Great Britain, National Osteoporosis Society. Glucocorticoid-induced osteoporosis. London: Royal College of Physicians of London, 2002. http://www.rcplondon.ac.uk/pubs/books/glucocorticoid/Glucocorticoid.pdf (accessed 25 Sept 2008).
3. eTG complete [CD-ROM]. Therapeutic Guidelines Limited, 2008
4. Cohen S, Levy RM, Keller M, et al. Risedronate therapy prevents corticosteroid-induced bone loss: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum 1999;42:2309–18. [PubMed]
5. Eastell R, Devogelaer JP, Peel NF, et al. Prevention of bone loss with risedronate in glucocorticoid-treated rheumatoid arthritis patients. Osteoporos Int 2000;11:331–7. [PubMed]
6. Mok CC, Tong KH, To CH, 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 2008;19:357–64. [PubMed]
7. Reid DM, Hughes RA, Laan RF, et al. Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial. European Corticosteroid-Induced Osteoporosis Treatment Study. J Bone Miner Res 2000;15:1006–13. [PubMed]
8. Kanis JA, Stevenson M, McCloskey EV, et al. Glucocorticoid-induced osteoporosis: a systematic review and cost-utility analysis. Health Technol Assess 2007;11:iii–iv, ix–xi, 1–231. [PubMed]