The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Pouneh K. Fazeli, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00759772
First received: September 24, 2008
Last updated: August 23, 2016
Last verified: August 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anorexia Nervosa Osteoporosis |
Drug: Teriparatide Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | The Role of PTH in Low Bone Mass in Anorexia Nervosa |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Bone metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Teriparatide
Teriparatide 20 mcg sc daily for 6 months
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo 20 mcg sc daily for 6 months
|
Detailed Description:
Anorexia Nervosa affects 0.5-1% of college-age women in the US and is associated with a number of significant medical conditions including bone loss. A majority of women with anorexia nervosa have bone loss and 50% have bone mineral density measurements greater than 2 standard deviations below normative means. Bone loss in anorexia nervosa is characterized by a decrease in bone formation, therefore therapy with an anabolic agent may be an effective treatment approach. In a randomized, single-blinded, placebo-controlled trial, we will study the effects of parathyroid hormone on low bone mass in anorexia nervosa, specifically looking at the effects of parathyroid hormone on bone mineral density, bone turnover markers and bone microarchitecture.
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00759772
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759772
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Eli Lilly and Company
Investigators
| Principal Investigator: | Pouneh K Fazeli, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Pouneh K. Fazeli, MD, Assistant Professor of Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00759772 History of Changes |
| Other Study ID Numbers: | 829 |
| Study First Received: | September 24, 2008 |
| Last Updated: | August 23, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
Anorexia Nervosa Disordered Eating Osteoporosis Parathyroid Hormone Bone |
Additional relevant MeSH terms:
|
Osteoporosis Anorexia Anorexia Nervosa Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Signs and Symptoms, Digestive |
Signs and Symptoms Feeding and Eating Disorders Mental Disorders Teriparatide Bone Density Conservation Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016