Trial · NCT00089843

Bone Loss in Women With Anorexia Nervosa

NCT00089843, Phase 2, Phase 3, Completed, Massachusetts General Hospital; results first posted 2012-06-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bone Loss in Women With Anorexia Nervosa. Trials, record NCT00089843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00089843

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bone Loss in Women With Anorexia Nervosa
NCT number: NCT00089843
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 77 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Anorexia Nervosa
Interventions: Testosterone, Actonel (risedronate), Placebo Actonel (risedronate), Placebo testosterone
First posted: 2004-08-17
Last updated: 2020-09-02
Results first posted: 2012-06-01

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Bone Mineral Density	Baseline and 12 months	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.
Secondary	Markers of Bone Metabolism	Baseline to 12 months	type 1 collagen C-telopeptide(CTX); The differences in log-transformed values are reported as percent change.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Bone Mineral Density	Baseline and 12 months	1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.	percent change	MEAN
SECONDARY	Markers of Bone Metabolism	Baseline to 12 months	1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.	percent change of CTX	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Bone Mineral Density	Actonel (Risedronate) 35 mg Weekly	3.2	95% Confidence Interval 1.8 to 4.6	percent change
Bone Mineral Density	Testosterone	-0.6	95% Confidence Interval -2.0 to 0.8	percent change
Markers of Bone Metabolism	Actonel (Risedronate)	-41	95% Confidence Interval -65 to -17	percent change of CTX
Markers of Bone Metabolism	Testosterone	-11	95% Confidence Interval -35 to 13	percent change of CTX

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Actonel and Active Testosterone Patch	19
Overall Study	STARTED	Active Actonel and Active Testosterone Patch	20
Overall Study	STARTED	Active Actonel and Placebo Testosterone	20
Overall Study	STARTED	Placebo Testosterone Patch and Placebo Actonel	18
Overall Study	COMPLETED	Placebo Actonel and Active Testosterone Patch	17
Overall Study	COMPLETED	Active Actonel and Active Testosterone Patch	16
Overall Study	COMPLETED	Active Actonel and Placebo Testosterone	15
Overall Study	COMPLETED	Placebo Testosterone Patch and Placebo Actonel	11
Overall Study	NOT COMPLETED	Placebo Actonel and Active Testosterone Patch	2
Overall Study	NOT COMPLETED	Active Actonel and Active Testosterone Patch	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Mild irritation at patch site	Skin and subcutaneous tissue disorders	Placebo Actonel and Active Testosterone Patch	9	19	18
other	Mild irritation at patch site	Skin and subcutaneous tissue disorders	Active Actonel and Active Testosterone Patch	11	20	27
other	Mild irritation at patch site	Skin and subcutaneous tissue disorders	Active Actonel and Placebo Testosterone	8	20	29
other	Mild irritation at patch site	Skin and subcutaneous tissue disorders	Placebo Testosterone Patch and Placebo Actonel	7	18	15
other	Mild increase in acne or oily skin	Skin and subcutaneous tissue disorders	Placebo Actonel and Active Testosterone Patch	8	19	21
other	Mild increase in acne or oily skin	Skin and subcutaneous tissue disorders	Active Actonel and Active Testosterone Patch	13	20	28
other	Mild increase in acne or oily skin	Skin and subcutaneous tissue disorders	Active Actonel and Placebo Testosterone	13	20	33
other	Mild increase in acne or oily skin	Skin and subcutaneous tissue disorders	Placebo Testosterone Patch and Placebo Actonel	12	18	33
other	Mild increase in body hair growth	Skin and subcutaneous tissue disorders	Placebo Actonel and Active Testosterone Patch	6	19	11
other	Mild increase in body hair growth	Skin and subcutaneous tissue disorders	Active Actonel and Active Testosterone Patch	7	20	12

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Actonel and Active Testosterone Patch
Total, all-cause mortality	Active Actonel and Active Testosterone Patch
Total, all-cause mortality	Active Actonel and Placebo Testosterone
Total, all-cause mortality	Placebo Testosterone Patch and Placebo Actonel
Total, other adverse events	Placebo Actonel and Active Testosterone Patch	12	19
Total, other adverse events	Active Actonel and Active Testosterone Patch	16	20
Total, other adverse events	Active Actonel and Placebo Testosterone	16	20
Total, other adverse events	Placebo Testosterone Patch and Placebo Actonel	12	18
Total, serious adverse events	Placebo Actonel and Active Testosterone Patch	6	19
Total, serious adverse events	Active Actonel and Active Testosterone Patch	1	20

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
17592924	DERIVED

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
R01DK052625	IGF-I and Bone Loss in Women with Anorexia Nervosa	KLIBANSKI, ANNE	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	1997 to 2015	NIH RePORTER
UL1RR025758	Harvard Clinical and Translational Science Center (UL1)	NADLER, LEE MARSHALL	HARVARD MEDICAL SCHOOL	NATIONAL CENTER FOR RESEARCH RESOURCES	2008 to 2011	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00089843

GET https://conductscience.org/api/trials/v1/NCT00089843/events?page=2

API reference For AI assistants