Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis - Full Text View

Sponsor:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00757393

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 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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dietary Supplements Diets Exercise and Physical Fitness Osteoporosis

Drug Information available for: Somatropin Calcium gluconate Vitamin D Somatotropin

U.S. FDA Resources

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
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
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.

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
Toronto, Ontario, Canada

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:	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

Keywords provided by The Hospital for Sick Children:

Growth hormone
Pediatrics
Vitamin D
Calcium
Exercise

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Ergocalciferols
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
Bone Diseases

Hormones
Pharmacologic Actions
Calcium, Dietary
Vitamin D
Musculoskeletal Diseases
Vitamins
Osteoporosis, Postmenopausal
Micronutrients

ClinicalTrials.gov processed this record on February 09, 2010