Study design (if review, criteria of inclusion for studies)
RCT
Participants
Patients with a lumbar spine (LS), total hip (TH) or femoral neck (FN) bone mineral density (BMD) Z-score of -1 or less
Interventions
patients were randomised to receive risedronate 35 mg weekly or placebo, and calcium (1g)+vitamin D(3) (800IU).
Outcome measures
BMD Z-scores, change in LS, TH and FN BMD
Main 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.
Authors' conclusions
After two years treatment there was a significant increase in LS BMD with weekly risedronate compared to placebo.
Keywords: risedronate; Bisphosphonates; Bone Density Conservation Agents; pharmacological_intervention;