NCT00283595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

October 16, 2012

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

3.1 years

First QC Date

January 27, 2006

Results QC Date

August 16, 2012

Last Update Submit

August 31, 2020

Conditions

Anorexia NervosaOsteopeniaOsteoporosisEating Disorders

Keywords

Anorexia NervosaEating disorderBoneGrowth hormoneOsteopeniaOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • Bone Metabolism

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

    Baseline, 12 weeks

Secondary Outcomes (1)

  • IGF-1 Level

    Baseline, 12 Weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Treatment with rHGH

Drug: Recombinant Human Growth Hormone

2

PLACEBO COMPARATOR

Treatment with Placebo

Drug: Placebo for Recombinant Human Growth Hormone

Interventions

Recombinant Human Growth HormoneDRUG

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

Also known as: Nutropin AQ
1
Placebo for Recombinant Human Growth HormoneDRUG

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

Also known as: Placebo for Nutropin AQ
2

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • women between 14 to 45 years with anorexia nervosa

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusettes General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Anorexia NervosaBone Diseases, MetabolicOsteoporosisFeeding and Eating Disorders

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Mental DisordersBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Anne Klibanski, MD
Organization
Massachusetts General Hospital
aklibanski@partners.org
617-726-3870

Study Officials

  • Anne Klibanski, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

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
Chief, Neuroendocrine Unit

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 30, 2006

Study Start

January 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

September 2, 2020

Results First Posted

October 16, 2012

Record last verified: 2020-08

Locations

US(1)