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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
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

30 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
September 24, 2008
Last Updated
April 5, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Eli Lilly and Company
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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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