NCT00757393

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

7 years

First QC Date

September 22, 2008

Last Update Submit

August 30, 2021

Conditions

Osteoporosis

Keywords

Growth hormonePediatricsVitamin DCalciumExercise

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (4)

  • Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline values of fracture frequency

    2 years

  • 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

    2 years

  • Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline measures of bone quality

    2 years

  • Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline values of BMC corrected for height

    2 years

Study Arms (2)

1

ACTIVE COMPARATOR
Dietary Supplement: Vitamin D + Calcium + Exercise program

2

EXPERIMENTAL
Drug: Vitamin D + Calcium + Exercise program + Humatrope

Interventions

Vitamin D + Calcium + Exercise programDIETARY_SUPPLEMENT

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

1
Vitamin D + Calcium + Exercise program + HumatropeDRUG

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.

Also known as: Growth Hormone
2

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

OsteoporosisMotor Activity

Interventions

Vitamin DCalciumHuman Growth HormoneGrowth Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsPituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Etienne Sochett, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Endocrinologist

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations

CA(1)