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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Femoral Head Avascular Necrosis

Intervention / Treatment
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* Drug: Pamidronate Disodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pamidronate Disodium<br> | Drug: Pamidronate Disodium<br>* Pamidronate will be given intravenously over one hour, one day per month for three out of every four months. The initial dose is 0.5mg/kg and subsequent doses are 1mg/kg. Infusions will continue for at least one year with a second year possibly recommended by the surgeon from data on the x-ray and bone scan.<br>* Other names: Pamidronate Disodium DIN: 002244550;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Avascular necrosis | Prevention of femoral head collapse and the degree of avascular necrosis following treatment with bisphosphonates as determined clinically and radiographically | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities Scales for Kids (ASK) | Validated questionnaire (ASK) is used to assess impact of avascular necrosis and femoral head collapse on patient functioning | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Avascular Necrosis, Bisphosphonates, Pamidronate