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Trial · NCT00145704

Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density

NCT00145704, Not applicable, Terminated, State University of New York - Upstate Medical University; results first posted 2013-04-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density. Trials, record NCT00145704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00145704

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Trial

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

Title
Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density
NCT number
NCT00145704
Status
Terminated
Phases
Not applicable
Enrollment
6 participants, actual
Lead sponsor
State University of New York - Upstate Medical University
Conditions
Osteopenia
Interventions
bisphosphonate therapy (risedronate), Vitamin D supplement, Calcium
First posted
2005-09-05
Last updated
2013-04-08
Results first posted
2013-04-08
Limitations and caveats
Early termination due to low enrollment, and lost to follow up of three subjects. Data was limited and therefore not reviewed/analyzed

Source ClinicalTrials.gov

Registered outcomes1

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

ListOutcomeTime frameDescription
PrimaryChange in Total Body Bone Mineral Density During an 18 Month Period18 months
For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1 monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.

Outcomes1

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Total Body Bone Mineral Density During an 18 Month Period18 monthsData analyis halted, due to low enrollment,no outcomes to report

Results by group0

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

None in this release.

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDBisphosphonate and Growth Hormone3
Overall StudySTARTEDGrowth Hormone Only3
Overall StudyCOMPLETEDBisphosphonate and Growth Hormone0
Overall StudyCOMPLETEDGrowth Hormone Only0
Overall StudyNOT COMPLETEDBisphosphonate and Growth Hormone3
Overall StudyNOT COMPLETEDGrowth Hormone Only3

Adverse events0

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

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityBisphosphonate and Growth Hormone Use
Total, all-cause mortalityGrowth Hormone Only
Total, other adverse eventsBisphosphonate and Growth Hormone Use03
Total, other adverse eventsGrowth Hormone Only03
Total, serious adverse eventsBisphosphonate and Growth Hormone Use03
Total, serious adverse eventsGrowth Hormone Only03

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Bisphosphonate and Growth Hormone Use vs Growth Hormone Only: serious adverse events

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/NCT00145704

GET https://conductscience.org/api/trials/v1/NCT00145704/registered