The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
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ClinicalTrials.gov Identifier: NCT00759772 |
Recruitment Status
:
Completed
First Posted
: September 25, 2008
Results First Posted
: March 28, 2017
Last Update Posted
: May 11, 2017
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Anorexia Nervosa Osteoporosis | Drug: Placebo Drug: Teriparatide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | The Role of PTH in Low Bone Mass in Anorexia Nervosa |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | February 22, 2016 |
Actual Study Completion Date : | February 22, 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Teriparatide |
Drug: Teriparatide
20 mcg sc daily for 6 months
|
Placebo Comparator: Placebo |
Drug: Placebo
sc daily for 6 months
|
- Percent Change in Lumbar Spine Bone Mineral Density [ Time Frame: Baseline and 6 months ]Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)

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Ages Eligible for Study: | 30 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759772
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Pouneh K Fazeli, MD | Massachusetts General Hospital |
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 |
First Posted: | September 25, 2008 Key Record Dates |
Results First Posted: | March 28, 2017 |
Last Update Posted: | May 11, 2017 |
Last Verified: | April 2017 |
Keywords provided by Pouneh K. Fazeli, MD, 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 Metabolic Diseases |
Signs and Symptoms, Digestive Signs and Symptoms Feeding and Eating Disorders Mental Disorders Teriparatide Bone Density Conservation Agents Physiological Effects of Drugs |