Preventive use of risedronate can help to reduce bone loss and, possibly, the risk of bone fractures in children and teenagers taking steroids to control their rheumatic disease, a clinical trial found.
The study based on trial findings, “The prevention and treatment of glucocorticoid-induced osteopaenia in juvenile rheumatic disease: A randomised double-blind controlled trial,” were published in EClinicalMedicine.
Children and teens with chronic rheumatic diseases, including juvenile idiopathic arthritis (JIA), juvenile systemic lupus erythematosus (JSLE), juvenile dermatomyositis (JDM) and juvenile vasculitis, who regularly take steroids to control their symptoms are at high risk of bone fractures due to the loss of bone mass.
“Steroids reduce peak bone mass and fracture risk increases as steroid dose increases. The current guidelines for adults are that those treated with GCs [glucocorticoids] should receive prophylactic [preventive] treatment for the prevention of bone loss. No such recommendations are in place for children,” the researchers wrote.
Risedronate belongs to a class of compounds called biphosphanates, preventive treatments to slow bone loss and avoid fractures in people with osteoporosis, a disease in which bones become gradually thinner and more fragile.
Investigators at multiple institutes and hospitals in the U.K. reported on a clinical trial assessing the effectiveness of risedronate or alfacalcidol (a compound similar to vitamin D that is normally used as a supplement) in reducing bone loss and preventing bone fractures as a consequence of steroid-induced osteopenia in children and teenagers with rheumatic disorders. (Osteopenia is a disorder marked by thinner and weaker bones that’s very similar to osteoporosis, but less severe.)
The multicenter, randomized, and placebo-controlled trial (2005-003129-23; ISRCTN66814619) enrolled 217 children and adolescents (ages 4 to 18) either starting on or with established use of a steroid therapy. All were recruited from 11 treatment sites across the U.K.
Participants were randomly assigned to treatment either with risedronate (69 participants), alfacalcidol (71 participants), or a placebo (77 participants) for up to one year.
The trial’s primary outcome was to assess changes in bone mineral density in the spine (lumbar spine bone mineral density z-score, or LSaBMD z-score) from study start (baseline) to one year after the start of treatment. A secondary outcome was to evaluate the rate of bone fractures.
After one year of treatment, LSaBMD z-scores remained stable in children given placebo (−1.15 to −1.13), decreased slightly in children treated with alfacalcidol (−0.96 to −1.00), and increased in children treated with risedronate (−0.99 to −0.75).
Group comparisons revealed significant differences in the change in LSaBMD z-scores between children in the placebo and risedronate groups, and between children in the risedronate and the alfacalcidol groups. No significant differences were found in the changes in LSaBMD z-scores between those in the placebo and alfacalcidol groups.
Investigators also found statistically significant bodywide differences in bone mineral density in children treated with risedronate compared to those given a placebo.
No significant differences were reported in the rate of bone fractures, or in the frequency of adverse or serious adverse events among the three groups.
“We have demonstrated that the bisphosphonate risedronate results in statistically and, we believe, clinically meaningful increases in bone mass in both the whole body and the lumbar spine, a site at particular risk for fracture in children with low bone mass in association with inflammatory conditions,” the investigators wrote.
“The drug was well tolerated with no significant increase in side effects over the comparators. We would advise consideration of risedronate in children and young people with inflammatory conditions receiving steroids, especially those considered at higher risk for fracture,” they added.