- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218710
Bone Structure in Patients with Adult Onset Growth Hormone Deficiency Assessed Using High Resolution Peripheral Quantitative Computed Tomography
March 18, 2025 updated by: Marianne Andersen, Odense University Hospital
Bone Geometry, Volumetric Density, Microarchitecture and Estimated Bone Strength Assessed by High Resolution Peripheral Quantitative Computed Tomography in Patients with Adult Onset Growth Hormone Deficiency
The aim of the study is to assess bone geometry, bone compartment specific volumetric densities and micro-architecture as well as to evaluate non-invasive estimates of bone strength in patients with adult onset growth hormone deficiency.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Odense, Denmark, 5000
- Department of Endocrinology, Odense University Hospital
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Odense, Denmark, 5000
- Department M
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Region syddanmark
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Odense, Region syddanmark, Denmark, 5000
- Endocrinological department M, Odense University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients are all seen at the Odense University Hospital at the department of Endocrinology.
All patients at the hypophysis clinic were checked and those receiving growth hormone replacement therapy were invited to participate.
Description
Inclusion Criteria:
- Men and women diagnosed with Adult onset Growth Hormone Deficiency
- Age between 18-80
- Informed consent
Exclusion Criteria:
- Competing bone disease (e.g.. Mb. Paget, myelomatosis, osteogenesis imperfecta, osteoporosis, primary hyperparathyroidism)
- Ongoing medical treatment affecting bone metabolism (eg. osteoporosis medications)
- Ongoing pregnancy or breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Growth hormone deficiency (GHD)
Pituitary patients with GHD
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healthy controls
Sex and age-matched healthy controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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volumetric bone mineral density in grams per cc
Time Frame: 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
August 7, 2014
First Submitted That Met QC Criteria
August 14, 2014
First Posted (Estimated)
August 18, 2014
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 18, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20120156
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.