RecruitingPhase 2ACTRN12610000407099

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.


Sponsor

The Royal Alexandria Hospital for Children

Enrollment

140 participants

Start Date

Jan 12, 2011

Study Type

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

Sex: Both males and femalesMin Age: 5 YearssMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a bone-strengthening drug called zoledronic acid, given by IV, can help children and young adolescents with Perthes disease — a condition where the ball of the hip joint (femoral head) loses its blood supply and collapses. The hope is that the drug will slow or prevent the collapse of the bone, leading to a better-shaped hip joint and less pain. Participants will receive either zoledronic acid or standard care alone for 12 months. You may be eligible if: - Your child has been diagnosed with unilateral Perthes disease within the past 6 months - Your child is between 5 and 16 years old - The affected bone still has more than 50% of its structure compared to the other side You may NOT be eligible if: - The hip bone loss is not due to Perthes disease - Your child has received bisphosphonate treatment before - Your child is pregnant or sexually active without using contraception - Your child has untreated rickets within the past year - Your child takes certain medications (e.g., steroids, growth hormone, anticonvulsants, calcitriol) - Your child has abnormal liver, thyroid, vitamin D, or kidney function Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 reconsti

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)

Auckland, New Zealand

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ACTRN12610000407099