Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis

This study is currently recruiting participants.
Verified September 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Etienne Sochett, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00757393
First received: September 22, 2008
Last updated: September 5, 2013
Last verified: September 2013
  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: 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

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 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

No publications provided

Responsible Party: Etienne Sochett, Staff Endocrinologist, 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 5, 2013
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 April 17, 2014