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Zoledronate Increases Bone Mineral Density in Nonambulant Children With Cerebral Palsy: A Randomized Controlled Trial

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Název: Zoledronate Increases Bone Mineral Density in Nonambulant Children With Cerebral Palsy: A Randomized Controlled Trial
Autoři: Jakob Bie Granild-Jensen, Bjarne Møller-Madsen, Gija Rackauskaite, Stense Farholt, Charlotte Søndergaard, Tine Høg Sørensen, Esben Thyssen Vestergaard, Bente Lomholt Langdahl
Zdroj: Granild-Jensen, J B, Møller-Madsen, B, Rackauskaite, G, Farholt, S, Søndergaard, C, Sørensen, T H, Vestergaard, E T & Langdahl, B L 2023, 'Zoledronate increases bone mineral density in non-ambulant children with cerebral palsy: A randomized, controlled trial', Journal of Clinical Endocrinology and Metabolism, vol. 108, no. 11, dgad299, pp. 2840-2851. https://doi.org/10.1210/clinem/dgad299
Granild-Jensen, J B, Møller-Madsen, B, Rackauskaite, G, Farholt, S, Søndergaard, C, Sørensen, T H, Vestergaard, E T & Langdahl, B L 2023, 'Zoledronate increases bone mineral density in non-ambulant children with cerebral palsy : A randomized, controlled trial', The Journal of Clinical Endocrinology & Metabolism, vol. 108, no. 11, pp. 2840-2851. https://doi.org/10.1210/clinem/dgad299
Informace o vydavateli: The Endocrine Society, 2023.
Rok vydání: 2023
Témata: bisphosphonate, Lumbar Vertebrae/diagnostic imaging, lateral distal femur, Zoledronic Acid, Imidazoles/adverse effects, Zoledronic Acid/therapeutic use, children, Bone Density, Humans, Bone Density Conservation Agents/adverse effects, Child, Cerebral Palsy/drug therapy, cerebral palsy, Lumbar Vertebrae, Diphosphonates, Bone Density Conservation Agents, lumbar spine, Cerebral Palsy, zoledronate, Imidazoles, osteoporosis, 3. Good health, CPCHILD, fracture, Diphosphonates/therapeutic use, bone mineral density
Popis: Context Zoledronate appears to reduce fracture rates in children with cerebral palsy (CP), but no previous randomized, controlled trial has been performed to compare the effect of zoledronate to placebo in children with CP. Objective To investigate the effect of zoledronate on bone mineral density (BMD) Z-scores in children with nonambulant CP in a randomized, controlled, double-blind trial. Methods Nonambulant children with CP (5 to 16 years of age) were randomized 1:1 to receive 2 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 dual-energy x-ray absorptiometry 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 0.8 SD (95% CI: 0.4; 1.2) in the zoledronate group, which was significant when compared to 0.0 SD (95% CI: −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. Conclusion Zoledronate for 12 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.
Druh dokumentu: Article
Jazyk: English
ISSN: 1945-7197
0021-972X
DOI: 10.1210/clinem/dgad299
Přístupová URL adresa: https://pubmed.ncbi.nlm.nih.gov/37235798
http://www.scopus.com/inward/record.url?scp=85174751176&partnerID=8YFLogxK
https://doi.org/10.1210/clinem/dgad299
https://vbn.aau.dk/da/publications/dd2a8082-9d57-4ff0-9b58-ab91498ece0d
Rights: OUP Standard Publication Reuse
Přístupové číslo: edsair.doi.dedup.....2acaa2a5681f32838a225de674b6de59
Databáze: OpenAIRE
Popis
Abstrakt:Context Zoledronate appears to reduce fracture rates in children with cerebral palsy (CP), but no previous randomized, controlled trial has been performed to compare the effect of zoledronate to placebo in children with CP. Objective To investigate the effect of zoledronate on bone mineral density (BMD) Z-scores in children with nonambulant CP in a randomized, controlled, double-blind trial. Methods Nonambulant children with CP (5 to 16 years of age) were randomized 1:1 to receive 2 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 dual-energy x-ray absorptiometry 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 0.8 SD (95% CI: 0.4; 1.2) in the zoledronate group, which was significant when compared to 0.0 SD (95% CI: −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. Conclusion Zoledronate for 12 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.
ISSN:19457197
0021972X
DOI:10.1210/clinem/dgad299