This is a randomised study to assess the safety and efficacy of a combined drug and orthopaedic standard care compared to the standard orthopaedic care and treatment for Perthes Disease in children.
A study to assess the safety and efficacy of bisphosphonate treatment in childhood femoral avascular necrosis due to Perthes Disease compared to the standard orthopaedic treatment and care.
The Royal Alexandria Hospital for Children
140 participants
Jan 12, 2011
Interventional
Conditions
Summary
This study is a randomised study that will investigate the safety and effacy of intravenous Zoledronic Acid and standard care compared to Standard Care in children and young adolescents, diagnosed with Perthes Disease. The hypothesis is that 12 months of intravenous zoledronic acid will retard femoral head collapse resulting in: improved femoral head sphericity at 24 months and improved hip function and reduced hip pain at 24 months
Eligibility
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Interventions
1.An intravenous intervention of 0.025mg/Kg Zoledronic Acid (ZA) at each visit, the first being within 4 weeks of screening, then at 3 monthly intervals, (5 doses). 2.The calculated dose of reconstituted ZA will be diluted in 50ml of (0.9%) Normal Saline and infused over 30 minutes. The maximum dose to be given is 2 mg/infusion. 3. Vitamin D 400 International Units (IU) oral capsule supplementation daily for 15 months for duration of study
Locations(1)
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ACTRN12610000407099