The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
The Role of PTH in Low Bone Mass in Anorexia Nervosa
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 24, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2016
CompletedResults Posted
Study results publicly available
March 28, 2017
CompletedMay 11, 2017
April 1, 2017
7.5 years
September 24, 2008
February 8, 2017
April 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Baseline and 6 months
Study Arms (2)
Teriparatide
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Anorexia Nervosa
- Women, age 30-70 years
- Osteoporosis or history of clinical fractures (spine, wrist, hip or ribs)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Eli Lilly and Companycollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pouneh K. Fazeli, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Pouneh K Fazeli, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
September 24, 2008
First Posted
September 25, 2008
Study Start
September 1, 2008
Primary Completion
February 22, 2016
Study Completion
February 22, 2016
Last Updated
May 11, 2017
Results First Posted
March 28, 2017
Record last verified: 2017-04