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OpenTrials
Completed

NCT Number: NCT01724489

Study of Growth Hormone and Bone in Obesity

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.

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Key information

Conditions

Obesity Body Weight Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteopenia Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

growth hormone

Drug

Other names: Genotropin (Pfizer Inc.)

Placebo

Drug

Primary outcomes

  1. Bone Mineral Density

    Time frame: baseline and 18 months

    Change in BMD over 18 months in the GH vs placebo group

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institutes of Health (NIH)
  • Pfizer

Registry information

Official study title

Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Nov 9, 2012
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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