Study of Growth Hormone and Bone in Obesity

This study is currently recruiting participants.
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01724489
First received: November 7, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Obesity
Osteopenia
Drug: Growth hormone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: baseline and 18 months ] [ Designated as safety issue: No ]
    Change in BMD over 18 months in the GH vs placebo group


Estimated Enrollment: 75
Study Start Date: August 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Growth hormone
Other Name: Genotropin (Pfizer Inc.)
Placebo Comparator: Placebo
Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724489

Contacts
Contact: Anu V Gerweck, NP 617-724-1837 avgerweck@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anu V Gerweck, NP    617-724-1837    avgerweck@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Pfizer
Investigators
Principal Investigator: Karen Miller, MD Massachusetts General Hospital
Principal Investigator: Miriam Bredella, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Karen Klahr Miller, MD, Director, Neuroendocrine Research Program in Women's Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01724489     History of Changes
Other Study ID Numbers: 2012-D-002574
Study First Received: November 7, 2012
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Obesity
Bone Diseases, Metabolic
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014