Phase 2
Completed N=23
The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
Source: ClinicalTrials.gov NCT00759772 ↗Enrolled (actual)
23
Serious AEs
21.7%
Results posted
Mar 2017
Primary outcomePrimary: Percent Change in Lumbar Spine Bone Mineral Density — 5.6; 0.2 percentage of change — p=< 0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Lumbar Spine Bone Mineral Density |
5.6; 0.2 | < 0.01 sig |
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. Informational only — not medical advice.