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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000407099

Acronym

Zoledronic Acid in Perthes (ZAP)Disease.

Enrollment

140

Registered

2010-05-21

Start date

2011-01-12

Completion date

2015-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator)

Eligibility

Sex/Gender

All

Age

5 Years to 16 Years

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results