Phase 2
N=23
The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
Anorexia Nervosa · Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00759772 ↗Enrolled (actual)
23
Serious AEs
21.7%
Results posted
Mar 2017
Primary outcome: Primary: Percent Change in Lumbar Spine Bone Mineral Density — 5.6; 0.2 percentage of change — p=< 0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Teriparatide (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Lumbar Spine Bone Mineral Density |
5.6; 0.2 | < 0.01 sig |
Summary
Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa, or disordered eating. Women with decreased bone strength 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 -- parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.
Eligibility Criteria
Inclusion Criteria
- Anorexia Nervosa
- Women, age 30-70 years
- Osteoporosis or history of clinical fractures (spine, wrist, hip or ribs)
Exclusion Criteria
- Diseases known to affect bone metabolism
- Hyperparathyroidism
- Medications known to affect bone metabolism in last 12 weeks (or bisphosphonate use in last 1 year)
- Pregnant and/or breastfeeding
- Diabetes mellitus
- History of malignancy involving or affecting the bone, any active malignancy, and/or radiation therapy to the bone
- Fractures of a bone other than a finger or toe in last 1 year
Data sourced from ClinicalTrials.gov (NCT00759772). 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.