Effect of Supraphysiological rhGH on Bone Metabolism in Patients With Anorexia Nervosa
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Bone Metabolism
Study Overview
Brief Summary
Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength.
We are investigating whether a hormone that is naturally produced by the human body, called growth hormone, can help strengthen the bones of women with this type of disordered eating.
Detailed Description
- Twelve week study
- Eight visits, six of which can be conducted at your home physician's office
- Two bone density scans
- Hormonal and nutritional evaluations
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 14 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •women between 14 to 45 years with anorexia nervosa
Exclusion Criteria
- •pregnancy
- •previous history of malignancy.
- •oral contraceptive pills or other hormones within last 8 - 12 weeks
- •medications known to affect bone within last 12 weeks
- •fracture within last 6 months
Arms & Interventions
1
Treatment with rHGH
Intervention: Recombinant Human Growth Hormone (Drug)
2
Treatment with Placebo
Intervention: Placebo for Recombinant Human Growth Hormone (Drug)
Outcomes
Primary Outcomes
Bone Metabolism
Time Frame: Baseline, 12 weeks
Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks
Secondary Outcomes
- IGF-1 Level(Baseline, 12 Weeks)
Investigators
Karen Klahr Miller, MD
Chief, Neuroendocrine Unit
Massachusetts General Hospital