The Effect of Zoledronic Acid on Reducing Fracture Rates in Youth with Osteogenesis Imperfecta and Other Forms of Osteoporosis

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Submission ID :
ESPR242
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Abstract: :

Background: Bisphosphonates are anti-osteoclastic agents used to treat osteoporosis. Zoledronic acid (ZA) is a third-generation IV bisphosphonate commonly used in pediatrics. Several studies have demonstrated ZA safety for children, but efficacy to prevent fractures is uncertain.

Objective: Investigate the effectiveness of ZA to reduce fractures in children with osteogenesis imperfecta (OI) and other forms of osteoporosis.  

Methods: Retrospective chart review of patients treated with ZA for low bone density and fracture at The Children's Hospital of Philadelphia between 07/2010-10/2017. The primary outcome was the fracture (fx) rate, expressed as fx/yr. Treatment duration was calculated as time from first infusion to end of study or loss to follow-up. A pre-treatment baseline for each subject was determined using time period pre-ZA equal to treatment duration. We extracted demographics, diagnostic data, and details of ZA treatment. The Wilcoxon signed-rank test was used to compare pre- and post-ZA and present the results as median [interquartile range (IQR)].

Results: 125 patients (80 male), median age at first infusion 11 yrs (range of 0.5- 19), met inclusion criteria, including 39 OI and 86 non-OI patients. Median post-ZA follow-up time was 2.8 yrs (IQR: 1.5-4.5). Patients received a median of 3 ZA doses (IQR: 2-5) with median cumulative dose of 0.08 mg/kg (IQR: 0.04-0.16). ZA treatment led to statistically significant decreases in overall, long bone, and long bone and spine fx rate in the overall cohort and the subset with OI (Table 1). For non-OI patients, statistically significant decreases occurred for overall and long bone and spine fx rates. Decreases in fx rate were more likely in subjects with OI vs non-OI (67% vs 48%, p=0.05). Decreased fx rate was associated with greater number of infusions [4(IQR:2-6) vs 2(IQR:1-4), p<0.01] and greater cumulative ZA dose [0.11 mg/kg(IQR:0.04-0.20) vs 0.06 mg/kg(IQR:0.03-0.11), p<0.01] but did not differ by age or gender at first infusion.

Conclusions

We showed that ZA is effective at reducing fractures in pediatric patients with OI and other forms of osteoporosis. Non-OI patients showed a trend towards reduction in long bone fractures that did not reach statistical significance, likely due to the small number of pre-ZA fractures. This data supports the use of ZA to reduce fx rates in youth with OI and other forms of osteoporosis.  


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The Children’s Hospital of Philadelphia
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia

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