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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pamidronate Disodium | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamidronate Disodium | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Patients between the ages of 10 and 18 with:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Wright, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | Canada |
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| ID | Term |
|---|---|
| D005271 | Femur Head Necrosis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077268 | Pamidronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |