Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by The Hospital for Sick Children.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
The Hospital for Sick Children
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00757393
First received: September 22, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
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Purpose
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 optimal standard therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Dietary Supplement: Vitamin D + Calcium + Exercise program Drug: Vitamin D + Calcium + Exercise program + Humatrope |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis |
Resource links provided by NLM:
Further study details as provided by The Hospital for Sick Children:
Primary Outcome Measures:
- Test the hypothesis that growth hormone administered daily by subcutaneous injection for 2 years will result in a significantly greater BMD Z-score over optimal standard therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline values of fracture frequency [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline values of bone histomorphometric measures osteoid volume, surface, and width [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline measures of bone quality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline values of BMC corrected for height [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 28 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Dietary Supplement: Vitamin D + Calcium + Exercise program
Subjects is this arm of the study will receive a) a supplementation with vitamin D3, 1000 IU daily b) a dietary calcium intake set at DRI for age and a supplement used as needed to meet the requirement and c) a weight bearing exercise program appropriate for the underlying medical condition
|
| Experimental: 2 |
Drug: Vitamin D + Calcium + Exercise program + Humatrope
Subjects in this arm will receive the same as those in arm 1 as well as Humatrope by subcutaneous infection 7 days a week at a dose of 0.05 mg.kg/day.
Other Name: Growth Hormone
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 5 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757393
Contacts
| Contact: Etienne Sochett, MD | (416)813-7654 ext 7482 | etienne.sochett@sickkids.ca |
| Contact: Yesmino Elia | yesmino.elia@sickkids.ca |
Locations
| Canada, Ontario | |
| The Hospital for Sick Children | Not yet recruiting |
| Toronto, Ontario, Canada | |
| Contact: Etienne Sochett, MD (416)813-7482 | |
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
| Principal Investigator: | Etienne Sochett, MD | The Hospital for Sick Children |
More Information
No publications provided
| Responsible Party: | Etienne Sochett/Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00757393 History of Changes |
| Other Study ID Numbers: | 1000012269 |
| Study First Received: | September 22, 2008 |
| Last Updated: | September 22, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
Growth hormone Pediatrics Vitamin D Calcium Exercise |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Calcium, Dietary Vitamin D Ergocalciferols Vitamins |
Hormones Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on June 17, 2013