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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Terminated

CT.gov ID

NCT02007915

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Femoral Head Avascular Necrosis	Drug: Pamidronate Disodium	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pamidronate Disodium	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. Other Names: Pamidronate Disodium DIN: 002244550

Arm

Intervention/Treatment

Experimental: Pamidronate Disodium

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.

Other Names:

Pamidronate Disodium DIN: 002244550

Outcome Measures

Primary Outcome Measures

Avascular necrosis [2 years]
Prevention of femoral head collapse and the degree of avascular necrosis following treatment with bisphosphonates as determined clinically and radiographically

Secondary Outcome Measures

Activities Scales for Kids (ASK) [2 years]
Validated questionnaire (ASK) is used to assess impact of avascular necrosis and femoral head collapse on patient functioning

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.