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

Jakob Bie Granild-Jensen; Bjarne Møller-Madsen; Gija Rackauskaite; Stense Farholt; Charlotte Søndergaard; Tine Høg Sørensen; Esben Thyssen Vestergaard; Bente Lomholt Langdahl

doi:10.1210/clinem/dgad299

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

Jakob Bie Granild-Jensen^*, Bjarne Møller-Madsen, Gija Rackauskaite, Stense Farholt, Charlotte Søndergaard, Tine Høg Sørensen, Esben Thyssen Vestergaard, Bente Lomholt Langdahl

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

4 Citations (Scopus)

Abstract

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.

Original language	English
Journal	The Journal of Clinical Endocrinology & Metabolism
Volume	108
Issue	11
Pages (from-to)	2840-2851
Number of pages	12
ISSN	0021-972X
DOIs	https://doi.org/10.1210/clinem/dgad299
Publication status	Published - Nov 2023

Keywords

CPCHILD
bisphosphonate
bone mineral density
cerebral palsy
children
fracture
lateral distal femur
lumbar spine
osteoporosis
zoledronate

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10.1210/clinem/dgad299

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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, 108(11), 2840-2851. https://doi.org/10.1210/clinem/dgad299

@article{73b91004ec4842e2b3e4d517b2e106ff,

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

abstract = "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.",

keywords = "CPCHILD, bisphosphonate, bone mineral density, cerebral palsy, children, fracture, lateral distal femur, lumbar spine, osteoporosis, zoledronate",

author = "Granild-Jensen, {Jakob Bie} and Bjarne M{\o}ller-Madsen and Gija Rackauskaite and Stense Farholt and Charlotte S{\o}ndergaard and S{\o}rensen, {Tine H{\o}g} and Vestergaard, {Esben Thyssen} and Langdahl, {Bente Lomholt}",

year = "2023",

month = nov,

doi = "10.1210/clinem/dgad299",

language = "English",

volume = "108",

pages = "2840--2851",

journal = "The Journal of Clinical Endocrinology & Metabolism",

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Granild-Jensen, JB, Møller-Madsen, B, Rackauskaite, G, Farholt, S, Søndergaard, C, Sørensen, TH, Vestergaard, ET & Langdahl, BL 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

Zoledronate increases bone mineral density in non-ambulant children with cerebral palsy: A randomized, controlled trial. / Granild-Jensen, Jakob Bie; Møller-Madsen, Bjarne; Rackauskaite, Gija et al.
In: The Journal of Clinical Endocrinology & Metabolism, Vol. 108, No. 11, 11.2023, p. 2840-2851.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - Zoledronate increases bone mineral density in non-ambulant children with cerebral palsy

T2 - A randomized, controlled trial

AU - Granild-Jensen, Jakob Bie

AU - Møller-Madsen, Bjarne

AU - Rackauskaite, Gija

AU - Farholt, Stense

AU - Søndergaard, Charlotte

AU - Sørensen, Tine Høg

AU - Vestergaard, Esben Thyssen

AU - Langdahl, Bente Lomholt

PY - 2023/11

Y1 - 2023/11

N2 - 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.

AB - 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.

KW - CPCHILD

KW - bisphosphonate

KW - bone mineral density

KW - cerebral palsy

KW - children

KW - fracture

KW - lateral distal femur

KW - lumbar spine

KW - osteoporosis

KW - zoledronate

U2 - 10.1210/clinem/dgad299

DO - 10.1210/clinem/dgad299

M3 - Journal article

C2 - 37235798

SN - 0021-972X

VL - 108

SP - 2840

EP - 2851

JO - The Journal of Clinical Endocrinology & Metabolism

JF - The Journal of Clinical Endocrinology & Metabolism

IS - 11

ER -

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

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Keywords

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