Bone Structure in Patients With Adult Onset Growth Hormone Deficiency Assessed Using High Resolution Peripheral Quantitative Computed Tomography

August 14, 2014 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

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

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 Contact

Study Locations

  • Denmark
    • Region syddanmark
      • Odense, Region syddanmark, Denmark, 5000
        • Endocrinological department M, Odense University Hospital
        • Principal Investigator:
          • Kim Brixen, MD, PhD
        • Sub-Investigator:
          • Marianne Andersen, MD, PhD
        • Sub-Investigator:
          • Dorthe Glintborg, MD, PhD
        • Sub-Investigator:
          • Frantz Rom Poulsen, MD, PhD
        • Sub-Investigator:
          • Claus Andersen, MD
        • Sub-Investigator:
          • Stinus Hansen, MD, PhD
        • Sub-Investigator:
          • Vikram Vinod Shanbhogue, MD
        • Sub-Investigator:
          • Kristian Buch

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

Genders Eligible for Study

All

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
healthy controls
Growth hormone deficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
volumetric bone mineral density in grams per cc
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

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

September 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

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.

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