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Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis

NCT00757393 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-08-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

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.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Etienne Sochett, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00757393 on ClinicalTrials.gov