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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) | Baseline and 42 months |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) | Baseline and 42 months | Population includes those who completed a month 42 visit. | percent change in BMD | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) | Standard Dose Teriparatide | 7.69 | Standard Deviation 4.66 | percent change in BMD | |
| Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) | High Dose Teriparatide | 12.70 | Standard Deviation 5.54 | percent change in BMD |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DATA-HD Study | STARTED | Standard Dose Teriparatide | 39 | |
| DATA-HD Study | STARTED | High Dose Teriparatide | 37 | |
| DATA-HD Study | COMPLETED | Standard Dose Teriparatide | 31 | |
| DATA-HD Study | COMPLETED | High Dose Teriparatide | 29 | |
| DATA-HD Study | NOT COMPLETED | Standard Dose Teriparatide | 8 | |
| DATA-HD Study | NOT COMPLETED | High Dose Teriparatide | 8 | |
| DATA-HD Extension | STARTED | Standard Dose Teriparatide | 27 | |
| DATA-HD Extension | STARTED | High Dose Teriparatide | 26 | |
| DATA-HD Extension | COMPLETED | Standard Dose Teriparatide | 26 | |
| DATA-HD Extension | COMPLETED | High Dose Teriparatide | 26 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events26
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 | back pain | Musculoskeletal and connective tissue disorders | Standard Dose Teriparatide | 0 | 39 | |
| other | back pain | Musculoskeletal and connective tissue disorders | High Dose Teriparatide | 2 | 37 | |
| serious | wrist fracture | Musculoskeletal and connective tissue disorders | Standard Dose Teriparatide | 2 | 39 | |
| serious | wrist fracture | Musculoskeletal and connective tissue disorders | High Dose Teriparatide | 1 | 37 | |
| serious | anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Standard Dose Teriparatide | 0 | 39 | |
| serious | anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | High Dose Teriparatide | 1 | 37 | |
| serious | breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Standard Dose Teriparatide | 2 | 39 | |
| serious | breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | High Dose Teriparatide | 0 | 37 | |
| serious | clavicle fracture | Musculoskeletal and connective tissue disorders | Standard Dose Teriparatide | 1 | 39 | |
| serious | clavicle fracture | Musculoskeletal and connective tissue disorders | High Dose Teriparatide | 0 | 37 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Dose Teriparatide | 0 | 39 |
| Total, all-cause mortality | High Dose Teriparatide | 0 | 37 |
| Total, other adverse events | Standard Dose Teriparatide | 0 | 39 |
| Total, other adverse events | High Dose Teriparatide | 2 | 37 |
| Total, serious adverse events | Standard Dose Teriparatide | 9 | 39 |
| Total, serious adverse events | High Dose Teriparatide | 2 | 37 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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.
| Comparison | Source |
|---|---|
| Standard Dose Teriparatide vs High Dose Teriparatide: deaths from any cause | Trial comparisons |
| Standard Dose Teriparatide vs High Dose Teriparatide: serious adverse events | 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.
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