ObesityNCT01724489

Study of Growth Hormone and Bone in Obesity

A study testing Growth hormone in people with Obesity and Osteopenia, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Osteopenia
What is being tested?: Growth hormone
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 77 participants
Where: 1 siteUnited States
Study dates: Aug 2013to 1 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Ages 18-65 and generally healthy
BMI ≥ 25 kg/m2
Bone mineral density (BMD) T score ≤ -1.0 and > -2.5 (as measured by DXA)

Who cannot join

For women: amenorrhea for 3 months, pregnancy or breastfeeding, polycystic ovary syndrome
History of diabetes mellitus, cancer or other serious chronic disease
Use of osteoporosis medications
Anemia

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone

Obesity is an important risk factor for osteoporosis and fractures. With the growing prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this population is of importance to public health. Growth hormone (GH) is a critical mediator of bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of bone loss in obesity. The development of novel imaging techniques provides an opportunity to investigate the effects of GH on skeletal structure and strength, which will provide insights into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone loss in obesity may help identify new treatment targets for this important complication. The investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal health.

Conditions: Obesity, Osteopenia
Being tested: Growth hormone, Placebo
Medical subject headings: Obesity, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Growth hormoneDrug
Also called Genotropin (Pfizer Inc.)
PlaceboDrug

Study groups in NCT01724489
Study group	Role	What they receive
Growth Hormone	Active comparator	Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels. Receives: Drug: Growth hormone
Placebo	Placebo comparator	Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Bone Mineral Density
Change in BMD over 18 months in the GH vs placebo group
Measured: baseline and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 20131 Apr 2019

First posted9 Nov 2012 (estimated)
Study startAug 2013
Primary completion15 Nov 2018
Study completion1 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Massachusetts General 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01724489
Sponsor's protocol ID: 2012P002276
Status last verified: Dec 2019
First submitted: 7 Nov 2012
Last updated: 17 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone
ClinicalTrials.gov ID: NCT01724489
Acronym / sponsor ID: 2012P002276
Conditions: Obesity, Osteopenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), Pfizer
Study start: Aug 2013
Primary completion: 15 Nov 2018 (actual)
Study completion: 1 Apr 2019 (actual)
First posted: 9 Nov 2012 (estimated)
Results: Posted 17 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Growth Hormone	Active comparator	Drug: Growth hormoneGrowth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels.
Placebo	Placebo comparator	Drug: PlaceboPlacebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Ages 18-65 and generally healthy
BMI ≥ 25 kg/m2
Bone mineral density (BMD) T score ≤ -1.0 and > -2.5 (as measured by DXA)

Key exclusion criteria (4 listed)

For women: amenorrhea for 3 months, pregnancy or breastfeeding, polycystic ovary syndrome
History of diabetes mellitus, cancer or other serious chronic disease
Use of osteoporosis medications
Anemia

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
Growth hormoneAlso: Genotropin (Pfizer Inc.)	Drug	Growth Hormone
Placebo	Drug	Placebo

Primary outcome

Bone Mineral Density
Time frame: baseline and 18 months
Change in BMD over 18 months in the GH vs placebo group

Results and safety

Results posted to the registry on 17 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Growth Hormone	39	23
Placebo	38	26

Primary outcome: Bone Mineral Density

Time frame: baseline and 18 months. Mean (Standard Deviation). Unit: grams/cm^2

Measure	Growth Hormone n = 21	Placebo n = 25
Value	-0.015 (0.033)	-0.008 (0.034)

Population analysed: Two subjects from the growth hormone arm were not analyzed due to large amount of weight loss, which has a well-documented effect of decreasing BMD. AP spine bone density in one study subject in the placebo group was excluded because the scan was technically poor. These data were excluded before the study was unblinded.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Growth Hormone	0 of 39 (0%)	29 of 39 (74.4%)	0 of 39
Placebo	1 of 38 (2.6%)	13 of 38 (34.2%)	0 of 38

Limitations and caveats (from the sponsor): Study medication was discontinued at 18 months. Subjects were followed for an additional 6 months off of study medication. The data reported here are for the primary 18-month trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Obesity & Overweight, Vitamin D
Recruiting
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Active, not recruiting
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Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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.

Karen Miller, MD principal investigator

Massachusetts General Hospital

Miriam Bredella, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Growth hormone in people with Obesity and Osteopenia, run by Massachusetts General Hospital at 1 site in United States.

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 4 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 17 Dec 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 17 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Bone Mineral Density (time frame: baseline and 18 months). 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 NCT01724489.

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 17 Dec 2019.