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

Femoral Head Avascular Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02007915
• Other study ID #: 1000009396
• Status: Terminated
• Phase: N/A
• First received: December 2, 2013
• Last updated: October 11, 2017
• Start date: July 2009
• Est. completion date: June 2013

Study information

• Verified date: October 2017
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Head Avascular Necrosis
• Femur Head Necrosis
• Necrosis
• Osteonecrosis

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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