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Abstract
Introduction: Low bone mineral density (BMD) is prevalent in children with cerebral palsy, increasing fracture risk and compromising an optimal bone health trajectory through the lifespan. Zoledronate is increasingly used to improve the BMD, however, no randomized trial has evaluated the ef- fect. We performed a multi-center, randomized, controlled, double-blind trial to evaluate the effect of zoledronate in children with non-ambulant cerebral palsy.
Patients and methods: Two doses of placebo or zoledronate were infused at a 6-month interval. Dual X-ray absorptio- metries of the lumbar spine and lateral distal femur were done at baseline and 12months and the BMD Z-score changes were calculated. Growth was monitored using weight, bone age, pubertal staging, knee–heel length and blood biomarkers.
Results: Twenty-four participants were randomized and completed the study. Ten were treated with placebo. The fourteen participants in the zoledronate group experienced BMD Z-score gains of +0.8 SD at the lumbar spine and + 0.3 to +1.7 in the three regions of the lateral distal femur. Three of four gains were significantly different from the placebo group. Moderate to very severe influenza-like symptoms were common in the zoledronate group, but only after the first dose. Lasting side effects including growth changes were not encountered.
Conclusion: Zoledronate significantly increases BMD in children with cerebral palsy in 1year without affecting growth. First-dose side-effects were common and consider- able. Studies into lower first doses and long-term outcomes are needed.
Patients and methods: Two doses of placebo or zoledronate were infused at a 6-month interval. Dual X-ray absorptio- metries of the lumbar spine and lateral distal femur were done at baseline and 12months and the BMD Z-score changes were calculated. Growth was monitored using weight, bone age, pubertal staging, knee–heel length and blood biomarkers.
Results: Twenty-four participants were randomized and completed the study. Ten were treated with placebo. The fourteen participants in the zoledronate group experienced BMD Z-score gains of +0.8 SD at the lumbar spine and + 0.3 to +1.7 in the three regions of the lateral distal femur. Three of four gains were significantly different from the placebo group. Moderate to very severe influenza-like symptoms were common in the zoledronate group, but only after the first dose. Lasting side effects including growth changes were not encountered.
Conclusion: Zoledronate significantly increases BMD in children with cerebral palsy in 1year without affecting growth. First-dose side-effects were common and consider- able. Studies into lower first doses and long-term outcomes are needed.
| Translated title of the contribution | Zoledronate øger knogledensiteten hos ikke-gående børn med spastisk lammelse: Et klinisk lodtrækningsforsøg |
|---|---|
| Original language | English |
| Journal | Developmental Medicine and Child Neurology |
| Volume | 65 |
| Issue | S2 |
| Pages (from-to) | 67 |
| Number of pages | 1 |
| ISSN | 0012-1622 |
| DOIs | |
| Publication status | Published - May 2023 |
Research output
- 1 Conference abstract for conference
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Zoledronate increases bone mineral density in non-ambulant children with cerebral palsy: A randomized, controlled trial
Granild-Jensen, J. B., 2022.Research output: Contribution to conference › Conference abstract for conference › Research › peer-review