Study of Growth Hormone and Bone in Obesity
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Osteopenia
Intervention: Growth hormone (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Karen Miller, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
Miriam Bredella, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
Overall contact:
Anu V Gerweck, NP, Phone: 617-724-1837, Email: avgerweck@partners.org
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.
Clinical Details
Official title: Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Bone Mineral Density
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Anu V Gerweck, NP, Phone: 617-724-1837, Email: avgerweck@partners.org
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Anu V Gerweck, NP, Phone: 617-724-1837, Email: avgerweck@partners.org
Additional Information
Starting date: August 2013
Last updated: May 5, 2015
|
