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Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

Primary Purpose

Anorexia Nervosa, Osteopenia, Osteoporosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Recombinant Human Growth Hormone

Placebo for Recombinant Human Growth Hormone

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Eating disorder, Bone, Growth hormone, Osteopenia, Osteoporosis

Eligibility Criteria

14 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: women between 14 to 45 years with anorexia nervosa Exclusion Criteria: pregnancy previous history of malignancy. oral contraceptive pills or other hormones within last 8 - 12 weeks medications known to affect bone within last 12 weeks fracture within last 6 months

Sites / Locations

Massachusettes General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Treatment with rHGH

Treatment with Placebo

Outcomes

Primary Outcome Measures

Bone Metabolism

Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks

Secondary Outcome Measures

IGF-1 Level

Change in IGF-1 level between baseline and 12 weeks

Full Information

NCT ID

NCT00283595

First Posted

January 27, 2006

Last Updated

August 31, 2020

Sponsor

Massachusetts General Hospital

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00283595

Brief Title

Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

Official Title

Effect of Supraphysiological rhGH on Bone Metabolism in Patients With Anorexia Nervosa

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones 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, called growth hormone, can help strengthen the bones of women with this type of disordered eating.

Detailed Description

Twelve week study Eight visits, six of which can be conducted at your home physician's office Two bone density scans Hormonal and nutritional evaluations

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia Nervosa, Osteopenia, Osteoporosis, Eating Disorders

Keywords

Anorexia Nervosa, Eating disorder, Bone, Growth hormone, Osteopenia, Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Treatment with rHGH

Arm Title

Arm Type

Placebo Comparator

Arm Description

Treatment with Placebo

Intervention Type

Drug

Intervention Name(s)

Recombinant Human Growth Hormone

Other Intervention Name(s)

Nutropin AQ

Intervention Description

Dosage increased in steps for first four weeks. Self injection qd x 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo for Recombinant Human Growth Hormone

Other Intervention Name(s)

Placebo for Nutropin AQ

Intervention Description

Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks

Primary Outcome Measure Information:

Title

Bone Metabolism

Description

Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks

Time Frame

Baseline, 12 weeks

Secondary Outcome Measure Information:

Title

IGF-1 Level

Description

Change in IGF-1 level between baseline and 12 weeks

Time Frame

Baseline, 12 Weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Klibanski, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusettes General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

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