Risedronate may be clinically useful in the prevention and treatment of bone density loss in children and adolescents with rheumatic diseases who are receiving steroid treatment, according to study results published in EClinicalMedicine. This is the first randomized double-blind controlled trial investigating the prevention and treatment of steroid-induced osteopenia in a pediatric population.
Researchers recruited 217 patients to determine the efficacy of risedronate or alfacalcidol compared with placebo, as determined by lumbar spine bone mineral density (BMD) in pediatric patients on steroid treatment with chronic rheumatic diseases. Patients were randomly assigned to 3 groups that received placebo (n=77), alfacalcidol (n=71), or risedronate (n=69). All patients also received 500 mg calcium and 400 international units (IU) vitamin D every day during the trial, which continued for 1 year with a 3-month posttrial follow-up.
The primary outcome was change in lumbar spine areal BMD z-score (LSaBMDz), measured by dual energy x-ray absorptiometry at the end of the 1-year study. Secondary outcome was rate of vertebral or other fractures during the trial period. Results revealed a statistically significant difference between all groups (P =.0007). Highly significant differences were observed for LSaBMDz between the risedronate and placebo groups (0.274; 95% CI, 0.061-0.487; P <.001), and between the risedronate and the alfacalcidol groups (0.326; 95% CI, 0.109-0.543; P <.001). No statistically significant difference was found between placebo and alfacalcidol groups (-0.052; 95% CI, -0.257 to 0.153).
Twenty-five hydroxyvitamin D levels were similar in all groups at baseline and increased in all groups at the 3-month follow-up. There were no significant differences observed in fracture frequency or in adverse reactions between groups. No changes were observed in calcium or phosphate levels; disease activity between the groups, as measured by C-reactive protein levels, also did not significantly differ throughout the study period.
Researchers of the study suggested that adjunctive treatment with risedronate may result in potentially clinically meaningful increases in bone mass in the whole body as well as in the lumbar spine, which is particularly prone to fractures in pediatric patients with inflammatory conditions receiving steroid treatment for chronic rheumatic disease. In addition, they indicated that alfacalcidol was ineffective in the prevention and treatment of steroid-induced bone loss.
Rooney M, Bishop N, Davidson J, et al. The prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: A randomised double-blind controlled trial. EClinicalMedicine. 2019;12:79-87.