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

Primary Purpose

Femoral Head Avascular Necrosis

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pamidronate Disodium
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Head Avascular Necrosis focused on measuring Adolescent, Avascular Necrosis, Bisphosphonates, Pamidronate

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pamidronate Disodium

Arm Description

Outcomes

Primary Outcome Measures

Avascular necrosis
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)
Validated questionnaire (ASK) is used to assess impact of avascular necrosis and femoral head collapse on patient functioning

Full Information

First Posted
December 2, 2013
Last Updated
October 11, 2017
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT02007915
Brief Title
The Use of Bisphosphonates in the Treatment of Avascular Necrosis of the Femoral Head
Official Title
The Use of Bisphosphonates in the Treatment of Avascular Necrosis of the Femoral Head
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
PI decision
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Head Avascular Necrosis
Keywords
Adolescent, Avascular Necrosis, Bisphosphonates, Pamidronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pamidronate Disodium
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pamidronate Disodium
Other Intervention Name(s)
Pamidronate Disodium DIN: 002244550
Intervention Description
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.
Primary Outcome Measure Information:
Title
Avascular necrosis
Description
Prevention of femoral head collapse and the degree of avascular necrosis following treatment with bisphosphonates as determined clinically and radiographically
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Activities Scales for Kids (ASK)
Description
Validated questionnaire (ASK) is used to assess impact of avascular necrosis and femoral head collapse on patient functioning
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Wright, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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