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Trial · NCT02176382

Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

NCT02176382, Phase 4, Completed, Massachusetts General Hospital; results first posted 2021-01-22

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Denosumab and Teriparatide Study (DATA-HD and DATA-EX). Trials, record NCT02176382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02176382

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Trial

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

Title
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
NCT number
NCT02176382
Status
Completed
Phases
Phase 4
Enrollment
76 participants, actual
Lead sponsor
Massachusetts General Hospital
Conditions
Postmenopausal Osteoporosis
Interventions
denosumab, teriparatide, Zoledronic acid
First posted
2014-06-27
Last updated
2021-02-09
Results first posted
2021-01-22

Source ClinicalTrials.gov

Registered outcomes1

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

ListOutcomeTime frameDescription
PrimaryPercent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)Baseline and 42 months

Outcomes1

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)Baseline and 42 monthsPopulation includes those who completed a month 42 visit.percent change in BMDMEAN

Results by group2

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

OutcomeGroupCategoryValueSpreadUnits
Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)Standard Dose Teriparatide7.69Standard Deviation 4.66percent change in BMD
Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)High Dose Teriparatide12.70Standard Deviation 5.54percent change in BMD

Participant flow12

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

PeriodMilestoneGroupParticipantsUnits counted
DATA-HD StudySTARTEDStandard Dose Teriparatide39
DATA-HD StudySTARTEDHigh Dose Teriparatide37
DATA-HD StudyCOMPLETEDStandard Dose Teriparatide31
DATA-HD StudyCOMPLETEDHigh Dose Teriparatide29
DATA-HD StudyNOT COMPLETEDStandard Dose Teriparatide8
DATA-HD StudyNOT COMPLETEDHigh Dose Teriparatide8
DATA-HD ExtensionSTARTEDStandard Dose Teriparatide27
DATA-HD ExtensionSTARTEDHigh Dose Teriparatide26
DATA-HD ExtensionCOMPLETEDStandard Dose Teriparatide26
DATA-HD ExtensionCOMPLETEDHigh Dose Teriparatide26

Adverse events26

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherback painMusculoskeletal and connective tissue disordersStandard Dose Teriparatide039
otherback painMusculoskeletal and connective tissue disordersHigh Dose Teriparatide237
seriouswrist fractureMusculoskeletal and connective tissue disordersStandard Dose Teriparatide239
seriouswrist fractureMusculoskeletal and connective tissue disordersHigh Dose Teriparatide137
seriousanal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)Standard Dose Teriparatide039
seriousanal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)High Dose Teriparatide137
seriousbreast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)Standard Dose Teriparatide239
seriousbreast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)High Dose Teriparatide037
seriousclavicle fractureMusculoskeletal and connective tissue disordersStandard Dose Teriparatide139
seriousclavicle fractureMusculoskeletal and connective tissue disordersHigh Dose Teriparatide037

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityStandard Dose Teriparatide039
Total, all-cause mortalityHigh Dose Teriparatide037
Total, other adverse eventsStandard Dose Teriparatide039
Total, other adverse eventsHigh Dose Teriparatide237
Total, serious adverse eventsStandard Dose Teriparatide939
Total, serious adverse eventsHigh Dose Teriparatide237

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
31447409RESULTPubMed
31674641BACKGROUNDPubMed
32790196BACKGROUNDPubMed

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 comparisons2

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

ComparisonSource
Standard Dose Teriparatide vs High Dose Teriparatide: deaths from any causeTrial comparisons
Standard Dose Teriparatide vs High Dose Teriparatide: serious adverse eventsTrial 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/NCT02176382

GET https://conductscience.org/api/trials/v1/NCT02176382/events?page=2