Trial · NCT00088153

Effects of Anorexia Nervosa on Bone Mass in Adolescents

NCT00088153, Phase 2, Phase 3, Completed, Massachusetts General Hospital; results first posted 2011-10-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Anorexia Nervosa on Bone Mass in Adolescents. Trials, record NCT00088153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00088153

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Trial

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

Title: Effects of Anorexia Nervosa on Bone Mass in Adolescents
NCT number: NCT00088153
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 110 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Anorexia Nervosa
Interventions: Physiologic Estrogen/progesterone, Placebo
First posted: 2004-07-21
Last updated: 2021-11-02
Results first posted: 2011-10-10

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Percent Change in Spine Bone Density Over the Study Duration (18 Months)	Baseline and 18 months	Bone density at the spine (lumbar 1-4 vertebrae) was measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 months, 12 months and 18 months. The primary outcome was the percent change in bone density at the spine from baseline to 18 months. Areal bone density is measured as g/cm2. The unit of measure for the percent change in bone density is 'percent' Percent change in bone density= \[\[Bone density at 18 months- Bone density at baseline)\*100/Bone density at baseline\]%
Primary	Change in Spine Bone Mineral Density Z-scores Over the Study Duration (18 Months)	Baseline and 18 months	Bone density at the spine (lumbar 1-4 vertebrae) was measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 months, 12 months and 18 months. The other primary outcome was the change in spine bone density Z-score from baseline to 18 months. The bone density Z-score is a standard deviation score that compares one's bone density to the mean for age and gender, and the Z-score, therefore, does not have any units. It is simply referred to as a Z-score. Change in bone density Z-score= \[Bone density Z-score at 18 months- Bone density Z-score at baseline\]
Secondary	Change in N-terminal Propeptide of Type 1 Procollagen (P1NP) Over the Study Duration (18 Months)	Baseline and 18 months	P1NP is a surrogate marker of bone formation that is measured in serum. P1NP levels were measured at baseline, 6, 12 and 18 months. A secondary outcome was the change in P1NP levels from baseline to 18 months: \[P1NP at 18 months - P1NP at baseline). The unit is ng/ml

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in Spine Bone Density Over the Study Duration (18 Months)	Baseline and 18 months	The number of participants was determined using power calculations based on preliminary data. For our primary longitudinal analysis, bone mineral density (BMD) changes were analyzed using a mixed model analysis of variance (intent-to-treat model). For secondary analysis, we examined BMD changes after controlling for age and weight changes.	Percent change	MEAN
SECONDARY	Change in N-terminal Propeptide of Type 1 Procollagen (P1NP) Over the Study Duration (18 Months)	Baseline and 18 months	The number of participants was determined based on our preliminary data. This analysis was based on completers only.	ng/ml	MEAN
PRIMARY	Change in Spine Bone Mineral Density Z-scores Over the Study Duration (18 Months)	Baseline and 18 months		Z -scores	MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Percent Change in Spine Bone Density Over the Study Duration (18 Months)	Physiologic Estrogen Replacement	2.6	Standard Deviation 1.0	Percent change
Percent Change in Spine Bone Density Over the Study Duration (18 Months)	Placebo	0.3	Standard Deviation 0.1	Percent change
Change in N-terminal Propeptide of Type 1 Procollagen (P1NP) Over the Study Duration (18 Months)	Physiologic Estrogen Replacement	-2.9	Standard Deviation 22.5	ng/ml
Change in N-terminal Propeptide of Type 1 Procollagen (P1NP) Over the Study Duration (18 Months)	Placebo	-10.9	Standard Deviation 27.0	ng/ml
Change in Spine Bone Mineral Density Z-scores Over the Study Duration (18 Months)	Physiologic Estrogen Replacement	-0.026	Standard Deviation 0.078	Z -scores
Change in Spine Bone Mineral Density Z-scores Over the Study Duration (18 Months)	Placebo	-0.236	Standard Deviation 0.091	Z -scores

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Physiologic Estrogen Replacement	55
Overall Study	STARTED	Placebo	55
Overall Study	COMPLETED	Physiologic Estrogen Replacement	31
Overall Study	COMPLETED	Placebo	30
Overall Study	NOT COMPLETED	Physiologic Estrogen Replacement	24
Overall Study	NOT COMPLETED	Placebo	25

Source ClinicalTrials.gov

Adverse events36

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	Nausea/vomiting	Gastrointestinal disorders	Physiologic Estrogen Replacement	14	55	14
other	Nausea/vomiting	Gastrointestinal disorders	Placebo	8	55	8
other	Dizziness	Vascular disorders	Physiologic Estrogen Replacement	6	55	6
other	Dizziness	Vascular disorders	Placebo	10	55	10
other	Headaches	Nervous system disorders	Physiologic Estrogen Replacement	10	55	10
other	Headaches	Nervous system disorders	Placebo	14	55	14
other	Bloating	Gastrointestinal disorders	Physiologic Estrogen Replacement	18	55	18
other	Bloating	Gastrointestinal disorders	Placebo	16	55	16
other	Constipation	Gastrointestinal disorders	Physiologic Estrogen Replacement	4	55	4
other	Constipation	Gastrointestinal disorders	Placebo	4	55	4

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Physiologic Estrogen Replacement
Total, all-cause mortality	Placebo
Total, other adverse events	Physiologic Estrogen Replacement	18	55
Total, other adverse events	Placebo	20	55
Total, serious adverse events	Physiologic Estrogen Replacement	12	55
Total, serious adverse events	Placebo	16	55

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21698665	RESULT	PubMed
22728230	DERIVED	PubMed
24021517	DERIVED	PubMed

Grants1

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
R01DK062249	Effects of Anorexia Nervosa on Peak Bone Mass	KLIBANSKI, ANNE	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2003 to 2015

Source NIH RePORTER

Trial comparisons1

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

Comparison
Physiologic Estrogen Replacement vs Placebo: serious adverse events

Source Trial comparisons

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/NCT00088153

GET https://conductscience.org/api/trials/v1/NCT00088153/events?page=2

API reference For AI assistants