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Context Glucocorticoids (GC) prescribed for chronic pediatric illnesses are associated with osteoporotic fractures. Objective To determine the efficacy and safety of intravenous (IV) zoledronic acid (ZA) compared with placebo to treat pediatric GC-induced osteoporosis (GIO). Patients, Design and Setting Children 5-17 years of age with GIO were enrolled in this multi-national randomized, double-blind, placebo-controlled phase 3 trial (ClinicaTrials.gov NCT 00799266). Interventions and Main Outcome Measures Eligible children were randomized 1:1 to six monthly IV ZA 0.05 mg/kg or IV placebo. The primary endpoint was the change in lumbar spine bone mineral density Z-score (LSBMDZ) from baseline to month 12. Incident fractures and safety were assessed. Results Thirty-four children were enrolled (mean age 12.6 ± 3.4 years [18 on ZA, 16 on placebo]), all with low-trauma vertebral fractures. LSBMDZ increased from −2.13 ± 0.79 to −1.49 ± 1.05 on ZA, compared with −2.38 ± 0.90 to −2.27 ± 1.03 on placebo (least squares means difference 0.41 [95% confidence interval 0.02, 0.81; p=0.04]); when corrected for height Z-score, the least squares means difference in LBMDZ was 0.75 [0.27, 1.22; p=0.004]. Two children on placebo had new low-trauma VF versus none on ZA. Adverse events (AEs) were reported in 15/18 children (83%) on ZA, and in 12/16 (75%) on placebo, most frequently within 10 days after the first infusion. There were no deaths, nor treatment discontinuations due to treatment-emergent AEs. Conclusions LSBMDZ increased significantly on ZA compared with placebo over one year in children with GIO. Most AEs occurred after the first infusion.

SummaryFracture rates were compared in children of different ethnic backgrounds from Johannesburg, South Africa. More white children fracture than black and mixed ancestry children. Reasons for this may be due to greater sports participation by whites and genetic protective factors in blacks. This has to be further investigated.IntroductionFracture rates in childhood are as high as those in the elderly. Recent research has been undertaken to understand the reasons for this, but there is little information available on ethnic differences in childhood fracture rates.MethodsUsing the birth to twenty longitudinal cohort of children, we retrospectively obtained information on fractures and their sites from birth to 14.9 years of age on 2031 participants. The ethnic breakdown of the children was black (B) 78%, white (W) 9%, mixed ancestry (MA) 10.5% and Indian (I) 1.5%.ResultsFour hundred and forty-one (22%) children had sustained a fracture one or more times during their lifetime (males 27.5% and females 16.3%; p < 0.001). The percentage of children fracturing differed between the ethnic groups (W 41.5%, B 19%, MA 21%, I 30%; p < 0.001). Of the 441 children reporting fractures, 89(20%) sustained multiple fractures. The most common site of fracture was the upper limb (57%).ConclusionMore white children fracture than black and mixed ancestry children. This is the first study to show ethnic differences in fracture rates among children. The reasons for these differences have to be further elucidated. Greater sports participation by whites and genetic protective factors in blacks may be contributing factors.

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Level III-retrospective study.