NCT00089843

Brief Summary

Women with Anorexia Nervosa have been found to have low bone density. The study will determine whether administration of low doses of a natural hormone, testosterone and/or risedronate, a medication to help prevent bone breakdown will improve or prevent bone loss in this condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2003

Longer than P75 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

June 1, 2003

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

June 1, 2012

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

4.8 years

First QC Date

August 16, 2004

Results QC Date

November 9, 2011

Last Update Submit

August 31, 2020

Conditions

Anorexia Nervosa

Keywords

Eating DisordersOsteopenia

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density

    Percent change in postero-anterior (PA) spine bone mineral density as measured by dual energy x-ray absorptiometry (DXA)over a 12-month period. The differences in log-transformed values are reported as percent change.

    Baseline and 12 months

Secondary Outcomes (1)

  • Markers of Bone Metabolism

    Baseline to 12 months

Study Arms (4)

2

ACTIVE COMPARATOR

Placebo Actonel (risedronate) and active testosterone patch

Drug: TestosteroneDrug: Placebo Actonel (risedronate)

3

ACTIVE COMPARATOR

Active Actonel (risedronate) and active testosterone patch

Drug: TestosteroneDrug: Actonel (risedronate)

4

ACTIVE COMPARATOR

Active Actonel (risedronate) and placebo testosterone

Drug: Actonel (risedronate)Drug: Placebo testosterone

1

PLACEBO COMPARATOR

Placebo testosterone patch and placebo Actonel (risedronate)

Drug: Placebo Actonel (risedronate)Drug: Placebo testosterone

Interventions

TestosteroneDRUG

Testosterone patch 150mcg daily

Also known as: Intrinsa
23
Actonel (risedronate)DRUG

Actonel (risedronate) 35mg PO one time weekly

Also known as: Actonel
34
Placebo Actonel (risedronate)DRUG

Placebo tablet identical in appearance to active Actonel (risedronate) tablet

12
Placebo testosteroneDRUG

Placebo patch identical in appearance to testosterone patch

14

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Anorexia Nervosa,
  • Over 18,
  • Female,
  • Decreased bone density

You may not qualify if:

  • Medications to increase bone density

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Miller KK, Wexler TL, Zha AM, Lawson EA, Meenaghan EM, Misra M, Binstock AB, Herzog DB, Klibanski A. Androgen deficiency: association with increased anxiety and depression symptom severity in anorexia nervosa. J Clin Psychiatry. 2007 Jun;68(6):959-65. doi: 10.4088/jcp.v68n0621.

    PMID: 17592924DERIVED

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating DisordersBone Diseases, Metabolic

Interventions

TestosteroneIntrinsaRisedronic Acid

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

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

Study Officials

  • Anne Klibanski, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Neuroendocrine Unit

Study Record Dates

First Submitted

August 16, 2004

First Posted

August 17, 2004

Study Start

June 1, 2003

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

September 2, 2020

Results First Posted

June 1, 2012

Record last verified: 2020-08

Locations

US(1)