Clinical trial NCT02007915: 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
Overall status: TERMINATED
Phase: NA
Conditions: Femoral Head Avascular Necrosis
Keywords: Adolescent
Avascular Necrosis
Bisphosphonates
Pamidronate
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Avascular necrosis
timeFrame: 2 years
Secondary outcomes:
measure: Activities Scales for Kids (ASK)
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: James Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: