Adult Onset Growth Hormone DeficiencyNCT02218710
Bone Structure in Patients With Adult Onset Growth Hormone Deficiency Assessed Using High Resolution Peripheral Quantitative Computed Tomography
An observational study of Adult Onset Growth Hormone Deficiency, run by Odense University Hospital at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adult Onset Growth Hormone Deficiency
- How many people
- 45 participants
- Where
- 3 sitesDenmark
- Study dates
- Sep 2014to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Men and women diagnosed with Adult onset Growth Hormone Deficiency
- Age between 18-80
- Informed consent
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Endocrinological department M, Odense University Hospital
Odense, Region Syddanmark, 5000
Department M
Odense, 5000
Department of Endocrinology, Odense University Hospital
Odense, 5000
About this study
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
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.
- Conditions
- Adult Onset Growth Hormone Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Growth hormone deficiency (GHD) | Pituitary patients with GHD | |
| healthy controls | Sex and age-matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
volumetric bone mineral density in grams per cc
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Onset Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Andersen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218710
- Sponsor's protocol ID
- S-20120156
- Status last verified
- Mar 2025
- First submitted
- 7 Aug 2014
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02218710
- Acronym / sponsor ID
- S-20120156
- Conditions
- Adult Onset Growth Hormone Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth hormone deficiency (GHD) | – | –Pituitary patients with GHD |
| healthy controls | – | –Sex and age-matched healthy controls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Men and women diagnosed with Adult onset Growth Hormone Deficiency
- Age between 18-80
- Informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
volumetric bone mineral density in grams per cc
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Onset Growth Hormone Deficiency, run by Odense University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volumetric bone mineral density in grams per cc (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.