Twelve-month treatment with zoledronate significantly increases bone mineral density (BMD) Z-scores without affecting growth in nonambulant children with cerebral palsy (CP), reports a study. However, side effects of the first dose are common.
“Zoledronate appears to reduce fracture rates in children with CP, but no previous randomized, controlled trial (RCT) has been performed to compare the effect of zoledronate to placebo in children with CP,” the authors said.
The current RCT was then conducted to examine the effect of zoledronate on BMD Z-scores in children with nonambulant CP (aged 5 to 16 years). Participants were randomized 1:1 to receive two doses of zoledronate or placebo at a 6-month interval.
The authors calculated the changes in BMD Z-scores at the lumbar spine and the lateral distal femur (LDF) using dual energy x-ray absorptiometry scans. They also monitored the participants for the following factors: weight, bone age, pubertal staging, knee-heel length, adverse events, biochemical markers, and questionnaires.
Of the 24 participants included, 14 were assigned to the zoledronate group. Those who received the study drug showed an increased lumbar spine BMD Z-score (mean, 0.8 SD, 95 percent confidence interval [CI], 0.4‒1.2) compared with children on placebo (mean, 0.0 SD, 95 percent CI, ‒0.3 to 0.3) Likewise, BMD Z-scores for LDF showed a greater increase in children treated with zoledronate.
Half of the patients on zoledronate reported experiencing severe acute phase symptoms, but these occurred only after the first dose. Of note, growth parameters did not differ between groups.
“Studies into lower first doses and long-term outcomes are needed,” the authors said.