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

Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Femoral Head Avascular Necrosis

Intervention: Pamidronate Disodium (Drug)

Phase: N/A

Status: Completed

Sponsored by: The Hospital for Sick Children

Official(s) and/or principal investigator(s):
James Wright, MD, Principal Investigator, Affiliation: The Hospital for Sick Children

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Avascular necrosis

Secondary outcome: Activities Scales for Kids (ASK)

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.

Eligibility

Minimum age: 10 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

The Hospital for Sick Children, Toronto, Ontario, Canada
Additional Information

Starting date: July 2009
Last updated: December 5, 2013

Page last updated: August 20, 2015

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