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Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Etienne Sochett, The Hospital for Sick Children.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00757393
First Posted: September 23, 2008
Last Update Posted: September 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Etienne Sochett, The Hospital for Sick Children
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Etienne Sochett, 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 ]

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 ]
  • 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 ]
  • Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline measures of bone quality [ Time Frame: 2 years ]
  • 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 ]

Estimated Enrollment: 28
Study Start Date: September 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Etienne Sochett, MD    416-813-6218    etienne.sochett@sickkids.ca   
Contact: Yesmino Elia, Msc.    416-813-7654 ext 1518    yesmino.elia@sickkids.ca   
Principal Investigator: Etienne Sochett, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Etienne Sochett, MD The Hospital for Sick Children
  More Information

Responsible Party: Etienne Sochett, Staff Endocrinologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00757393     History of Changes
Other Study ID Numbers: 1000012269
First Submitted: September 22, 2008
First Posted: September 23, 2008
Last Update Posted: September 9, 2013
Last Verified: September 2013

Keywords provided by Etienne Sochett, The Hospital for Sick Children:
Growth hormone
Pediatrics
Vitamin D
Calcium
Exercise

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Hormones
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hormones, Hormone Substitutes, and Hormone Antagonists