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

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ClinicalTrials.gov Identifier: NCT02218710
Recruitment Status : Unknown
Verified August 2014 by Marianne Andersen, Odense University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital

Brief Summary:
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.

Condition or disease
Adult Onset Growth Hormone Deficiency

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: 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
Study Start Date : September 2014
Estimated Primary Completion Date : June 2015


Group/Cohort
Growth hormone deficiency
healthy controls



Primary Outcome Measures :
  1. volumetric bone mineral density in grams per cc [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218710


Contacts
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Contact: Kristian Buch, Stud.med +45 29434376 krbuc08@student.sdu.dk

Locations
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Denmark
Endocrinological department M, Odense University Hospital
Odense, Region syddanmark, Denmark, 5000
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         
Sponsors and Collaborators
Odense University Hospital

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Responsible Party: Marianne Andersen, Associate Professor, DM, DMSc, PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02218710    
Other Study ID Numbers: S-20120156
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Physiological Effects of Drugs