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Sponsored by: |
The Hospital for Sick Children |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00757393 |
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 |
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Osteoporosis |
Dietary Supplement: Vitamin D + Calcium + Exercise program Drug: Vitamin D + Calcium + Exercise program + Humatrope |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis |
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 |
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1: Active Comparator |
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
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2: Experimental |
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.
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Ages Eligible for Study: | 5 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Etienne Sochett, MD | (416)813-7654 ext 7482 | etienne.sochett@sickkids.ca |
Contact: Yesmino Elia | yesmino.elia@sickkids.ca |
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada |
Principal Investigator: | Etienne Sochett, MD | The Hospital for Sick Children |
Responsible Party: | The Hospital for Sick Children ( Etienne Sochett/Principal Investigator ) |
Study ID Numbers: | 1000012269 |
Study First Received: | September 22, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00757393 History of Changes |
Health Authority: | Canada: Health Canada |
Growth hormone Pediatrics Vitamin D Calcium Exercise |
Cholecalciferol Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Bone Diseases, Metabolic Bone Density Conservation Agents Trace Elements |
Bone Diseases Hormones Calcium, Dietary Vitamin D Musculoskeletal Diseases Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Bone Diseases, Metabolic Bone Density Conservation Agents Bone Diseases |
Hormones Pharmacologic Actions Vitamin D Musculoskeletal Diseases Vitamins Micronutrients |