N/A
N=77
Study of Growth Hormone and Bone in Obesity
Obesity · Osteopenia
Bottom Line
View on ClinicalTrials.gov: NCT01724489 ↗Enrolled (actual)
77
Serious AEs
1.3%
Results posted
Dec 2019
Primary outcome: Primary: Bone Mineral Density — -0.015; -0.008 grams/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Growth hormone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density |
-0.015; -0.008 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01724489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.