The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
Primary Purpose
Anorexia Nervosa, Osteoporosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Teriparatide
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Disordered Eating, Osteoporosis, Parathyroid Hormone, Bone
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Teriparatide
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percent Change in Lumbar Spine Bone Mineral Density
Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)
Secondary Outcome Measures
Full Information
NCT ID
NCT00759772
First Posted
September 24, 2008
Last Updated
April 5, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00759772
Brief Title
The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
Official Title
The Role of PTH in Low Bone Mass in Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 22, 2016 (Actual)
Study Completion Date
February 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Osteoporosis
Keywords
Anorexia Nervosa, Disordered Eating, Osteoporosis, Parathyroid Hormone, Bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teriparatide
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sc daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Intervention Description
20 mcg sc daily for 6 months
Primary Outcome Measure Information:
Title
Percent Change in Lumbar Spine Bone Mineral Density
Description
Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)
Time Frame
Baseline and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pouneh K Fazeli, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
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