BARCELONA — Patients who use high-dose glucocorticoids can maintain or improve their bone mineral density with risedronate prophylaxis, Dr. Chi Chiu Mok reported at the annual European Congress of Rheumatology.
“The [American College of Rheumatology] recommends the first-line use of bisphosphonates in patients with T scores below -1 who are expected to use corticosteroids for more than 3 months,” said Dr. Mok of the department of medicine at Tuen Mun Hospital, Hong Kong.
“Multiple clinical trials have confirmed the efficacy of bisphosphonates in the prevention and treatment of glucocorticoid-induced bone loss, and sometimes have demonstrated antifracture efficacy. But most [of these trials] recruited patients taking a relatively small dose of steroids,” an equivalent of 7.5 mg/week of prednisolone or more.
Dr. Mok and colleagues randomized 120 patients with conditions requiring 0.5 mg/kg per day prednisolone (or an equivalent glucocorticoid dose) for 6 weeks or more to 1,000 mg/day calcium plus 5 mg/day risedronate (Actonel) or placebo for 6 months. Mean age was 43 years, and 30% were postmenopausal.
At the end of the double-blind trial, risedronate patients had a significantly greater change in bone mineral density (BMD) at the lumbar spine (0.9%) than did placebo-treated patients (−0.5%). This was significant even after adjusting for baseline BMD, age, gender, body mass index, and cumulative steroid dosage. Risedronate patients maintained BMD in the hip and the whole body overall. Placebo patients lost BMD in both measurements.
Steroid-naive patients, who accounted for about 60% of all patients, had similar results. The maximum dosage of prednisolone given during the trial averaged 0.7 mg/kg per day.
Sanofi Aventis provided free daily-dosed risedronate, but did not otherwise fund the trial. Dr. Mok said that no investigators had conflicts of interest with Sanofi Aventis.
Overall, 51 risedronate- and 52 placebo-treated patients completed the trial. Withdrawals mainly occurred because of the daily drug protocol, but several patients died from their underlying medical condition; two withdrawals occurred in the risedronate group because of adverse events (one skin rash and one dyspepsia).
No patients had preexisting vertebral or hip fractures, although about 50% of the patients were osteopenic. The trial was not powered to test the antifracture efficacy of risedronate.
“Risedronate should be considered for primary prevention of bone mineral loss during periods of high-dose glucocorticoid therapy,” Dr. Mok concluded.
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