An interventional study of Pamidronate Disodium in Femoral Head Avascular Necrosis, sponsored by The Hospital for Sick Children. Terminated at 1 site in Canada. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-10-13.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment
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.
182 studies on the registry are indexed under Osteonecrosis; 31 are open to participants now.
This study's enrollment of 20 is below the median of 51 across 96 interventional studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patients between the ages of 10 and 18 with:
Exclusion Criteria:
Drug: Pamidronate Disodium
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.
Also known as: Pamidronate Disodium DIN: 002244550
Avascular necrosis
Prevention of femoral head collapse and the degree of avascular necrosis following treatment with bisphosphonates as determined clinically and radiographically
Time frame: 2 years
Activities Scales for Kids (ASK)
Validated questionnaire (ASK) is used to assess impact of avascular necrosis and femoral head collapse on patient functioning
Time frame: 2 years
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children