Growth Hormone DisorderGETNCT00934063
An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®
An observational study of Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This observational study is conducted in Europe. The aim of this observational study is to investigate the changes in a score (GET-score) which includes quality of life, body composition and cholesterol metabolism in patients on growth hormone treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Growth Hormone Disorder, Adult Growth Hormone Deficiency
- What is being tested?
- somatropin and No treatment given
- Type of treatment
- Injection or infusion
- How many people
- 121 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with acquired growth hormone deficiency who have been deemed appropriate to receive Norditropin® as treatment and as part of routine out-patient care by the prescribing physician.
Who may be able to join
- Severe acquired growth hormone deficiency
- No treatment with somatropin in the last 24 months before study participation
- Written informed consent
Who cannot join
- Contraindications for the treatment with somatropin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin)
This observational study is conducted in Europe. The aim of this observational study is to investigate the changes in a score (GET-score) which includes quality of life, body composition and cholesterol metabolism in patients on growth hormone treatment. The GET score stands for: Growth hormone deficiency and Efficacy of Treatment, and is a quantitative measurement of the efficacy of the treatment with growth hormone in adults.
- Being tested
- somatropin, No treatment given
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
For s.c. (under the skin) injection. Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
No treatment givenOther
Control group not receiving treatment
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: somatropin | |
| B | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Secondary outcomes (11)
Health related quality of life (SF-36; EQ-5D)
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Disease related absences from work
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Bone mineral density DXA Z-score lumbar
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Total cholesterol, HDL, LDL
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Body composition: fat mass, fat-free mass, impedance (BIA)
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Waist-circumference
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Blood pressure
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Adverse Drug Reactions and Severe Adverse Drug Reactions
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Triceps skinfold thickness
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Upper arm circumference
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
IGF-I (Insulin-like growth factor 1)
Measured: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934063
- Sponsor's protocol ID
- GH-3709
- Acronym
- GET
- Status last verified
- Apr 2015
- First submitted
- 2 Jul 2009
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kann PH, Bergmann S, Bidlingmaier M, Dimopoulou C, Pedersen BT, Stalla GK, Weber MM, Meckes-Ferber S. Design of the Growth hormone deficiency and Efficacy of Treatment (GET) score and non-interventional proof of concept study. BMC Endocr Disord. 2018 Feb 13;18(1):10. doi: 10.1186/s12902-018-0237-3.
PubMed 29433573
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin)
- ClinicalTrials.gov ID
- NCT00934063
- Acronym / sponsor ID
- GET / GH-3709
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Jul 2009 (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.
This observational study is conducted in Europe. The aim of this observational study is to investigate the changes in a score (GET-score) which includes quality of life, body composition and cholesterol metabolism in patients on growth hormone treatment. The GET score stands for: Growth hormone deficiency and Efficacy of Treatment, and is a quantitative measurement of the efficacy of the treatment with growth hormone in adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: somatropin |
| B | – | Other: No treatment given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with acquired growth hormone deficiency who have been deemed appropriate to receive Norditropin® as treatment and as part of routine out-patient care by the prescribing physician.
Key inclusion criteria (3 listed)
- Severe acquired growth hormone deficiency
- No treatment with somatropin in the last 24 months before study participation
- Written informed consent
Key exclusion criteria (1 listed)
- Contraindications for the treatment with somatropin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatropinFor s.c. (under the skin) injection. Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
| No treatment givenControl group not receiving treatment | Other | B |
Primary outcome
Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
11 secondary outcomes
Health related quality of life (SF-36; EQ-5D)
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Disease related absences from work
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Bone mineral density DXA Z-score lumbar
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Total cholesterol, HDL, LDL
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Body composition: fat mass, fat-free mass, impedance (BIA)
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Waist-circumference
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Blood pressure
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Adverse Drug Reactions and Severe Adverse Drug Reactions
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Triceps skinfold thickness
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Upper arm circumference
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
IGF-I (Insulin-like growth factor 1)
Time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
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 29 Apr 2015.
- Derived from this study: PubMed 29433573Kann PH, Bergmann S, Bidlingmaier M, Dimopoulou C, Pedersen BT, Stalla GK, Weber MM, Meckes-Ferber S. Design of the Growth hormone deficiency and Efficacy of Treatment (GET) score and non-interventional proof of concept study. BMC Endocr Disord. 2018 Feb 13;18(1):10. doi: 10.1186/s12902-018-0237-3.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Growth Hormone Disorder
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Not yet recruiting
PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty
Frailty, Sarcopenia
Active, not recruitingPhase 3
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Breast Cancer
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
Active, not recruitingPhase 3
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Early Breast Cancer
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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 1 site in Germany.
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 1 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density (time frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00934063, which also lists 1 linked publication.
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 29 Apr 2015.