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Study of Growth Hormone and Bone in Obesity

NCT ID: NCT01724489

Last Updated: 2019-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2019-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Growth Hormone

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.

Group Type ACTIVE_COMPARATOR

Growth hormone

Intervention Type DRUG

Placebo

Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Growth hormone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Genotropin (Pfizer Inc.)

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Klahr Miller, MD

Chief, Neuroendocrine Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Miriam Bredella, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2012P002276

Identifier Type: -

Identifier Source: org_study_id