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Multicentre trial of weekly risedronate on bone density in adults with cystic fibrosis
Charles S Haworth1, Linda Sharples, Vikki Hughes
1Adult Cystic Fibrosis Centre, Papworth Hospital, Cambridge, CB23 3RE, UK. charles.haworth@papworth.nhs.uk
Background:
The aim of this study was to assess the efficacy, tolerability and safety of risedronate in adults with CF.
Methods:
Patients with a lumbar spine (LS), total hip (TH) or femoral neck (FN) bone mineral density (BMD) Z-score of -1 or less were randomised to receive risedronate 35 mg weekly or placebo, and calcium (1g)+vitamin D(3) (800IU).
Results:
At baseline, BMD Z-scores in the risedronate (n=17) and placebo (n=19) groups were similar. By 24 months, 7/17 risedronate patients vs 0/19 placebo patients stopped the study medication due to bone pain. After 24 months treatment, the mean difference (95% CI) in change in LS, TH and FN BMD between the risedronate vs placebo groups was 4.3% (0.4, 8.2) p=0.03; 4.0% (-0.5, 8.6) p=0.08; and 2.4% (-3.5, 8.2) p=0.41.
Conclusions:
After two years treatment there was a significant increase in LS BMD with weekly risedronate compared to placebo.
