The Use of Bisphosphonates in the Treatment of Avascular Necrosis of the Femoral Head

Not Applicable

Terminated

• Conditions: Femoral Head Avascular Necrosis
• Interventions: Drug: Pamidronate Disodium

• Registration Number: NCT02007915
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

To determine the safety and effectiveness of pamidronate in patients with radiographically proven avascular necrosis which are the result of unstable (acute) slipped capital femoral epiphysis, traumatic proximal femur fractures, traumatic hip dislocations, or idiopathic in nature.

Detailed Description

Avascular necrosis of the femoral head and collapse is a devastating condition in the pediatric patient population leading to degenerative arthritis and significant disability. Bisphosphonate therapy has been shown to be effective in the treatment of adults with avascular necrosis of the femoral head. For children and adolescents however, there is currently no effective treatment that prevents collapse of the femoral head. Some patients with proven avascular necrosis of the femoral epiphysis are treated with bisphosphonates (intravenous pamidronate) at the The Hospital for Sick Children. The main aim of this study is to prospectively collect data on HSC patients receiving bisphosphonate treatment and thereby report the effectiveness of this treatment in the prevention of femoral head collapse.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2011-05
• Study Completion: 2013-06
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients between the ages of 10 and 18 with:

• unstable slipped capital femoral epiphysis (defined as inability to bear weight) or acute slipped capital femoral epiphysis (defined as a separation of the epiphysis from the metaphysis of the proximal femur) who have been pinned either in situ or following reduction,
• traumatic hip dislocations or traumatic proximal femur fractures, or
• "idiopathic" avascular necrosis of the femoral head which includes unknown causes as well as Sickle Cell Disease, post radiation use, post chemotherapy treatment, and post steroid treatment.

Exclusion Criteria

• Decline to participate in study. (Patients will be still offered this therapy whether or not they wish to be included in the official study protocol. Clinical evaluations, laboratory and imaging tests would be unchanged if they choose to be treated with intravenous pamidronate)
• Significant femoral head collapse - judged radiographically by treating surgeon
• Idiopathic causes under the age of 10.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pamidronate Disodium	Pamidronate Disodium	-

Primary Outcome Measures

Name	Time	Method
Avascular necrosis	2 years	Prevention of femoral head collapse and the degree of avascular necrosis following treatment with bisphosphonates as determined clinically and radiographically

Secondary Outcome Measures

Name	Time	Method
Activities Scales for Kids (ASK)	2 years	Validated questionnaire (ASK) is used to assess impact of avascular necrosis and femoral head collapse on patient functioning

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada