The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (primary outcome).

Official Title
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The Role of PTH in Low Bone Mass in Anorexia Nervosa

Conditions
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Anorexia Nervosa, Osteoporosis

Intervention / Treatment
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* Drug: Placebo
* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Teriparatide<br> | Drug: Teriparatide<br>* 20 mcg sc daily for 6 months<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* sc daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Lumbar Spine Bone Mineral Density | Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period) | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia Nervosa, Disordered Eating, Osteoporosis, Parathyroid Hormone, Bone