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.
- Conditions
- Avascular Necrosis due to Perthes Disease.Musculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12610000407099
- Lead Sponsor
- The Royal Alexandria Hospital for Children
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 140
Diagnosis of unilateral Perthes Disease within the preceeding 6 months and with lateral pillar >50% of the contralateral side at the time of enrolment.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if 12 months of intravenous zoledronic acid improves femoral head sphericity in children and adolescents with Perthes disease. Deformity Index (DI) using Anteroposterior (AP) radiograph of the pelvis the DI compares the affected hip to the unaffected side. All measurements performed blinded at 24 months by a single observer.[At 24 months following randomisation.]
- Secondary Outcome Measures
Name Time Method