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 -