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

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ClinicalTrials.gov Identifier: NCT02007915
Recruitment Status : Terminated (PI decision)
First Posted : December 11, 2013
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
James Wright, The Hospital for Sick Children

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : July 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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 Name: Pamidronate Disodium DIN: 002244550




Primary Outcome Measures :
  1. Avascular necrosis [ Time Frame: 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 :
  1. Activities Scales for Kids (ASK) [ Time Frame: 2 years ]
    Validated questionnaire (ASK) is used to assess impact of avascular necrosis and femoral head collapse on patient functioning



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007915


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: James Wright, MD The Hospital for Sick Children

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Responsible Party: James Wright, Surgeon-in-Chief & Chief of Perioperative Services, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02007915     History of Changes
Other Study ID Numbers: 1000009396
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Keywords provided by James Wright, The Hospital for Sick Children:
Adolescent
Avascular Necrosis
Bisphosphonates
Pamidronate
Additional relevant MeSH terms:
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Osteonecrosis
Necrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Diphosphonates
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs