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

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ClinicalTrials.gov Identifier: NCT00759772
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : March 28, 2017
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Pouneh K. Fazeli, MD, Massachusetts General Hospital

Study Description
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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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density

Arms and Interventions
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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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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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    Key Record Dates
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