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

This study is ongoing, but not recruiting participants.
Eli Lilly and Company
Information provided by (Responsible Party):
Pouneh K. Fazeli, MD, Massachusetts General Hospital Identifier:
First received: September 24, 2008
Last updated: February 27, 2016
Last verified: February 2016

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
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: September 2016
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.

Ages Eligible for Study:   30 Years to 70 Years
Genders 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
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Please refer to this study by its identifier: NCT00759772

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Eli Lilly and Company
Principal Investigator: Pouneh K Fazeli, MD Massachusetts General Hospital
  More Information

Additional Information:
Responsible Party: Pouneh K. Fazeli, MD, Assistant Professor of Medicine, Massachusetts General Hospital Identifier: NCT00759772     History of Changes
Other Study ID Numbers: 829 
Study First Received: September 24, 2008
Last Updated: February 27, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Anorexia Nervosa
Disordered Eating
Parathyroid Hormone

Additional relevant MeSH terms:
Anorexia Nervosa
Bone Diseases
Bone Diseases, Metabolic
Feeding and Eating Disorders
Mental Disorders
Musculoskeletal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on May 25, 2016