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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Anorexia Nervosa; Osteoporosis	Drug: Placebo; Drug: Teriparatide	Phase 2

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 (primary outcome).

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	30 Years to 70 Years (Adult, Senior)
Sexes 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	September 25, 2008
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