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

NCT ID: NCT02007915

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Femoral Head Avascular Necrosis

Keywords

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Adolescent Avascular Necrosis Bisphosphonates Pamidronate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pamidronate Disodium

Group Type EXPERIMENTAL

Pamidronate Disodium

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Pamidronate Disodium DIN: 002244550

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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James Wright

Surgeon-in-Chief & Chief of Perioperative Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Wright, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000009396

Identifier Type: -

Identifier Source: org_study_id