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

Inclusion Criteria1

  • Diagnosis of unilateral Perthes Disease within the preceeding 6 months and with lateral pillar >50% of the contralateral side at the time of enrolment.

Exclusion Criteria7

  • Diagnosis of Avascular Necrosis of the femoral head not due to Perthes Disease.
  • Previous treatment of bisphosphonates.
  • Current pregnancy or sexually active and not using a medically acceptable form of birth control.
  • Untreated rickets within 1 year of enrolment.
  • History of clinically significant organic or psychiatric findings on physical examination, which in the opinion of the investigator would prevent the patient from completing the study.
  • History of using any of the following medications: regardless of dose, for at least one month, within 3 months of enrolment: Anabolic agents, Calcitriol, Calcitonin, Fluroide (except dental health products), Glucocorticoids (does not include inhaled Glucocorticoids), Growth Hormone, Parathyroid hormone (PTH), Strontium, anticonvulsant medication.
  • At screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 upper limit of normal, thyroid-stimulating hormone (TSH) outside of the normal reference range, Vitamin D < 50nmol/l or Glommerula Filtration Rate (GFR) < 60 ml/min as per the Schwartz formula.

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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