Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bone Diseases, Metabolic
Musculoskeletal Diseases
Calcium, Dietary
Ergocalciferols
Hormones
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Hormones, Hormone Substitutes, and Hormone Antagonists
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014