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

This study is currently recruiting participants.
Verified February 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00759772
First received: September 24, 2008
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Bone metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2008
Estimated Primary Completion Date: December 2014 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759772

Contacts
Contact: Pouneh K Fazeli, MD 617-726-1347 pkfazeli@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Pouneh K Fazeli, MD     617-726-1347     pkfazeli@partners.org    
Principal Investigator: Anne Klibanski, MD            
Sub-Investigator: Pouneh K Fazeli, MD            
Sub-Investigator: Karen K Miller, MD            
Sub-Investigator: Elizabeth A Lawson, MD            
Sub-Investigator: Joel Finkelstein, MD            
Sub-Investigator: David Herzog, MD            
Sub-Investigator: Erinne Meenaghan, NP            
Sponsors and Collaborators
Massachusetts General Hospital
Eli Lilly and Company
Investigators
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
  More Information

Additional Information:
Neuroendocrine research studies in Anorexia Nervosa at MGH  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Anne Klibanski, MD, Anne Klibanski, MD/Laurie Carrol Guthart Professor of Medicine, Massachusetts General Hospital/Harvard Medical School., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00759772     History of Changes
Other Study ID Numbers: 829
Study First Received: September 24, 2008
Last Updated: February 15, 2013
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:
Anorexia
Anorexia Nervosa
Osteoporosis
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
 Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013