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

NCT02007915 | Terminated

• 1 other identifier: 1000009396
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Head Avascular Necrosis

Keywords

Adolescent; Avascular Necrosis; Bisphosphonates; Pamidronate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Activities Scales for Kids (ASK)

  2 years

Study Arms (1)

Pamidronate Disodium

EXPERIMENTAL

Drug: Pamidronate Disodium

Interventions

Pamidronate Disodium 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.

Also known as: Pamidronate Disodium DIN: 002244550

Pamidronate Disodium

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Femur Head Necrosis; Osteonecrosis

Interventions

Pamidronate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• James Wright, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon-in-Chief & Chief of Perioperative Services

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 11, 2013
• Study Start: July 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2013
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

CA (1)