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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Pouneh K. Fazeli, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00759772
First received: September 24, 2008
Last updated: April 5, 2017
Last verified: April 2017
  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: Placebo Drug: Teriparatide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
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 Pouneh K. Fazeli, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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)


Enrollment: 23
Study Start Date: September 2008
Study Completion Date: February 22, 2016
Primary Completion Date: February 22, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Teriparatide Drug: Teriparatide
20 mcg sc daily for 6 months
Placebo Comparator: Placebo Drug: Placebo
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 (primary outcome).
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759772

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

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
Study First Received: September 24, 2008
Results First Received: February 8, 2017
Last Updated: April 5, 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
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017