Trial intelligence / Profile preview

Growth Hormone Therapy in Pediatric Osteoporosis

NCT00757393Phase 3

Key facts

Status: Completed
Start: Sep 2008
Primary completion: Sep 2015
Countries: 1
Sponsor: SickKids
Modality: Hormone, rProtein (Recombinant Protein), Biologic

Drugs: somatropin
Conditions: osteoporosis

Overview

Phase 3, randomised, open-label trial of somatropin in osteoporosis (2 arms), sponsored by SickKids. Primary endpoint: Bone Mineral Density Z-score at 2 years. Started Sep 2008; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Standard Therapy
Vitamin D + Calcium + Exercise
Growth Hormone + Standard Therapy
Humatrope + Vitamin D + Calcium + Exercise

Who it enrols

Children aged 5-16 with adynamic osteoporosis confirmed by bone biopsy, stable underlying primary disorder if present, and no recent antiresorptive therapy.

Endpoints

Primary

Bone Mineral Density Z-score2 years

Secondary

Fracture Frequency2 years
Bone Histomorphometric Measures2 years
Bone Quality Measures2 years
Bone Mineral Content2 years

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