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.
|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|
- 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
|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)|
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.
|Contact: Anu V Gerweck, NPfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Anu V Gerweck, NP 617-724-1837 email@example.com|
|Principal Investigator:||Karen Miller, MD||Massachusetts General Hospital|
|Principal Investigator:||Miriam Bredella, MD||Massachusetts General Hospital|