ICCBH2019 Poster Presentations (1) (226 abstracts)
Protocol: a randomized trial of zoledronate in children with cerebral palsy
TH Soerensen 6 , Jakob Bie Granild-Jensen 1, , Esben Thyssen Vestergaard 1 , Gija Rackauskaite 4 , Charlotte Soendergaard 5 , Stense Farholt 4 , Bjarne Møller-Madsen 2 & Bente Langdahl 3
1Child and Youth, Randers Regional Hospital, Randers, Denmark; 2Danish Orthopaedic Research, dpor.dk, Aarhus, Denmark; 3Osteoporosis Clinic, Aarhus University Hospital, Aarhus, Denmark; 4Child and Youth, Aarhus University Hospital, Aarhus, Denmark; 5Child and Youth, Regional Hospital West, Herning, Denmark; 6Department of Pediatrics, Aalborg University Hospital, Aalborg, Denmark.
Objectives: Low bone mineral density is highly prevalent in non-ambulant cerebral palsy and is associated with a high risk of fractures. In most cases these fractures occur with no or minimal trauma. Primary and secondary fracture prevention strategies differ between sites and countries. In order to inform these strategies we intend to complete a trial of Zoledronate in children with Cerebral Palsy. We hypothesize that Zoledronate treatment significantly increases bone mineral density after 1 year compared with placebo.
Methods: We plan to include 52 children aged 5 to 17 years with non-ambulant Cerebral Palsy in a randomized controlled trial. Each child will receive 2 double blinded treatments of intravenous Zoledronate or placebo at a 6-month interval. The first dose is 0.025 mg/kg, the second dose is 0.050 mg/kg. The primary endpoint is the change in bone mineral density after 12 months as measured by Dual-energy X-ray Absorptiometry. We will use 3 regions of the distal femur as the primary site of measure.
Results: 15 children have been included since October 2017. No serious adverse events have ocurred. More sites have been recruited and now 5 sites are including patients. Inclusion will continue until the end of 2019. Results are expected in 2021.
Conclusion: This study will add knowledge on the effect of Zoledronate in children with Cerebral Palsy and strengthen the fracture prevention strategies. The results may thus improve the quality of life of children with non-ambulant Cerebral Palsy. Further, health care spending on fracture management may be reduced.
Disclosure: The authors declared no competing interests.
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