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Study of Growth Hormone and Bone in Obesity

Primary Purpose

Obesity, Osteopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Growth hormone
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Growth Hormone

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Bone Mineral Density
Change in BMD over 18 months in the GH vs placebo group

Secondary Outcome Measures

Full Information

First Posted
November 7, 2012
Last Updated
December 4, 2019
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01724489
Brief Title
Study of Growth Hormone and Bone in Obesity
Official Title
Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH), Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Osteopenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Growth Hormone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.
Intervention Type
Drug
Intervention Name(s)
Growth hormone
Other Intervention Name(s)
Genotropin (Pfizer Inc.)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Bone Mineral Density
Description
Change in BMD over 18 months in the GH vs placebo group
Time Frame
baseline and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Miller, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miriam Bredella, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Growth Hormone and Bone in Obesity

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