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Study of Growth Hormone and Bone in Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Pfizer
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01724489
First received: November 7, 2012
Last updated: May 8, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Other
Official Title: Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone

Resource links provided by NLM:


Further study details as provided by Karen Klahr Miller, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: baseline and 18 months ]
    Change in BMD over 18 months in the GH vs placebo group


Enrollment: 75
Study Start Date: August 2013
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: November 2018 (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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724489

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Pfizer
Investigators
Principal Investigator: Karen Miller, MD Massachusetts General Hospital
Principal Investigator: Miriam Bredella, MD Massachusetts General Hospital
  More Information

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: 2012P002276
Study First Received: November 7, 2012
Last Updated: May 8, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017