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Trial · NCT01406444

IGF-1 and Bone Loss in Women With Anorexia Nervosa

NCT01406444, Not applicable, Completed, Massachusetts General Hospital; results first posted 2020-07-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. IGF-1 and Bone Loss in Women With Anorexia Nervosa. Trials, record NCT01406444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01406444

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Trial

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

Title
IGF-1 and Bone Loss in Women With Anorexia Nervosa
NCT number
NCT01406444
Status
Completed
Phases
Not applicable
Enrollment
148 participants, actual
Lead sponsor
Massachusetts General Hospital
Conditions
Anorexia Nervosa, Osteopenia, Osteoporosis
Interventions
rhIGF-1, Risedronate, Placebo
First posted
2011-08-01
Last updated
2020-07-17
Results first posted
2020-07-17

Source ClinicalTrials.gov

Registered outcomes2

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

ListOutcomeTime frameDescription
PrimaryPostero-anterior Spine Bone Mineral Density by DXA12 MonthsPostero-anterior spine bone mineral density by dual-energy X-ray absorptiometry
SecondaryLateral Spine Bone Mineral Density by DXA12 MonthsLateral spine bone mineral density by dual-energy X-ray absorptiometry

Outcomes2

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPostero-anterior Spine Bone Mineral Density by DXA12 Monthsg/cm2LEAST_SQUARES_MEAN
SECONDARYLateral Spine Bone Mineral Density by DXA12 Monthsg/cm2LEAST_SQUARES_MEAN

Results by group6

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

OutcomeGroupCategoryValueSpreadUnits
Postero-anterior Spine Bone Mineral Density by DXArhIGF-1 Followed by Risedronate0.891Standard Error 0.014g/cm2
Postero-anterior Spine Bone Mineral Density by DXARisedronate0.887Standard Error 0.014g/cm2
Postero-anterior Spine Bone Mineral Density by DXAPlacebo0.874Standard Error 0.013g/cm2
Lateral Spine Bone Mineral Density by DXArhIGF-1 Followed by Risedronate0.695Standard Error 0.012g/cm2
Lateral Spine Bone Mineral Density by DXARisedronate0.677Standard Error 0.012g/cm2
Lateral Spine Bone Mineral Density by DXAPlacebo0.666Standard Error 0.010g/cm2

Participant flow9

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDrhIGF-1 Followed by Risedronate33
Overall StudySTARTEDRisedronate33
Overall StudySTARTEDPlacebo16
Overall StudyCOMPLETEDrhIGF-1 Followed by Risedronate23
Overall StudyCOMPLETEDRisedronate24
Overall StudyCOMPLETEDPlacebo14
Overall StudyNOT COMPLETEDrhIGF-1 Followed by Risedronate10
Overall StudyNOT COMPLETEDRisedronate9
Overall StudyNOT COMPLETEDPlacebo2

Adverse events27

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherInjection Site Irritation and/or BruisingSkin and subcutaneous tissue disordersrhIGF-1 Followed by Risedronate153324
otherInjection Site Irritation and/or BruisingSkin and subcutaneous tissue disordersRisedronate113314
otherInjection Site Irritation and/or BruisingSkin and subcutaneous tissue disordersPlacebo2162
otherNauseaGastrointestinal disordersrhIGF-1 Followed by Risedronate1331
otherNauseaGastrointestinal disordersRisedronate53314
otherNauseaGastrointestinal disordersPlacebo1161
otherUpset StomachGastrointestinal disordersrhIGF-1 Followed by Risedronate3333
otherUpset StomachGastrointestinal disordersRisedronate1331
otherUpset StomachGastrointestinal disordersPlacebo0160
otherAcid RefluxGastrointestinal disordersrhIGF-1 Followed by Risedronate4336

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityrhIGF-1 Followed by Risedronate033
Total, all-cause mortalityRisedronate033
Total, all-cause mortalityPlacebo016
Total, other adverse eventsrhIGF-1 Followed by Risedronate1933
Total, other adverse eventsRisedronate1833
Total, other adverse eventsPlacebo516
Total, serious adverse eventsrhIGF-1 Followed by Risedronate033
Total, serious adverse eventsRisedronate033
Total, serious adverse eventsPlacebo016

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01DK052625IGF-I and Bone Loss in Women with Anorexia NervosaKLIBANSKI, ANNEMASSACHUSETTS GENERAL HOSPITALNATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES1997 to 2015

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/NCT01406444

GET https://conductscience.org/api/trials/v1/NCT01406444/events?page=2