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Zoledronate increases bone mineral density in non-ambulant children with cerebral palsy: A randomized, controlled trial

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AIM: To investigate the effect of zoledronate on bone mineral density (BMD) Z-scores in children with non-ambulant cerebral palsy in a randomized, controlled, double-blind trial.

METHOD: Five- to sixteen-year-old, non-ambulant children with cerebral palsy were randomized 1:1 to receive two doses of zoledronate or placebo at a 6-month interval. BMD Z-score changes at the lumbar spine and the lateral distal femur (LDF) were calculated from DXA scans. Monitoring included weight, bone age, pubertal staging, knee-heel length, adverse events, biochemical markers, and questionnaires.

RESULTS: Twenty-four participants were randomized and all completed the study. Fourteen were assigned to zoledronate. The mean lumbar spine BMD Z-score increased (95% CIs) 0.8 SD (0.4; 1.2) in the zoledronate group, which was significant when compared to 0.0 SD (-0.3; 0.3) in the placebo group. Similarly, the LDF BMD Z-scores increased more in the zoledronate group. Severe acute phase symptoms affected 50% of the patients in the zoledronate group, but were reported exclusively after the first dose. Growth parameters were similar in both groups.

INTERPRETATION: Zoledronate for twelve months increased BMD Z-scores significantly without affecting growth, but first-dose side-effects were common and considerable. Studies into lower first doses and long-term outcomes are needed.

TidsskriftThe Journal of Clinical Endocrinology & Metabolism
Sider (fra-til)2840-2851
Antal sider12
StatusUdgivet - nov. 2023

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