Study of Growth Hormone and Bone in Obesity

Obesity Clinical Trial

Official title:

Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724489
• Other study ID #: 2012P002276
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: April 1, 2019

Study information

• Verified date: December 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 1, 2019
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Obesity
• Osteopenia

Intervention

Drug:
• Growth hormone

• Placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institutes of Health (NIH), Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density	Change in BMD over 18 months in the GH vs placebo group	baseline and 18 months