Status:
COMPLETED
Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Osteoporosis
Eligibility:
All Genders
5-16 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to test the hypothesis that growth hormone, administered daily by subcutaneous injection for 2 years will result in a significantly greater BMD Z-score over opti...
Detailed Description
Osteoporosis is a skeletal disorder characterized by a parallel loss of bone mineral and matrix which results in enhanced bone fragility and an increased risk of fractures. The associated fractures, a...
Eligibility Criteria
Inclusion
- Adynamic form of osteoporosis based on bone biopsy findings
- Age range 5-16 years
- Willingness to comply with the protocol
- Underlying primary disorder (when present) in a maintenance phase of treatment and the patient considered to be clinically stable
Exclusion
- Previous treatment with an antiresorptive agent within 1 year of commencement of the study
- Unstable primary disorder (when present)
- Significant psychosocial difficulties that will likely preclude compliance with the protocol
- Any contraindication to the use of growth hormone
- Patients with severe osteoporosis and past medical history of malignancy
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00757393
Start Date
September 1 2008
End Date
September 1 2015
Last Update
August 31 2021
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8