Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Calcium; Calcium, Dietary; Ergocalciferols; Hormones; Vitamin D; Vitamins

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