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Study of Growth Hormone and Bone in Obesity

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ClinicalTrials.gov Identifier: NCT01724489
Recruitment Status : Active, not recruiting
First Posted : November 9, 2012
Last Update Posted : October 11, 2017
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment
Obesity Osteopenia Drug: Growth hormone Drug: Placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone
Study Start Date : August 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Somatropin
U.S. FDA Resources

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724489

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

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
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

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