Trial · NCT01199614
HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism
NCT01199614, Phase 3, Completed, Columbia University; results first posted 2024-07-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism. Trials, record NCT01199614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01199614
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism
- NCT number
- NCT01199614
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 62 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Hypoparathyroidism
- Interventions
- open-label PTH(1-84)
- First posted
- 2010-09-13
- Last updated
- 2024-07-05
- Results first posted
- 2024-07-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Dose of Calcium Supplementation | Baseline, up to 4 years | Serum and urinary calcium levels maintained by change in requirements for calcium supplementation. |
| Secondary | Percent Change in BMD by DXA | Baseline, up to 4 years | Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DXA) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Dose of Calcium Supplementation | Baseline, up to 4 years | Analyzed data from this cohort included 27 evaluable subjects treated with open-label PTH(1-84) for 4 years. | percent change in dose | MEAN |
| SECONDARY | Percent Change in BMD by DXA | Baseline, up to 4 years | Analyzed data from this cohort included 27 evaluable subjects treated with open-label PTH(1-84) for 4 years. | 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 |
|---|---|---|---|---|---|
| Change in Dose of Calcium Supplementation | Open-label PTH(1-84) | 37 | Standard Deviation 43 | percent change in dose | |
| Percent Change in BMD by DXA | Open-label PTH(1-84) | 5.5 | Standard Deviation 9 | percent change in BMD |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open-label PTH(1-84) | 62 | |
| Overall Study | Completed | Open-label PTH(1-84) | 27 | |
| Overall Study | COMPLETED | Open-label PTH(1-84) | 13 | |
| Overall Study | NOT COMPLETED | Open-label PTH(1-84) | 49 |
Source ClinicalTrials.gov
Adverse events14
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 | Muscular/skeletal event | Musculoskeletal and connective tissue disorders | Open-label PTH(1-84) | 16 | 62 | |
| other | Circulatory event | Vascular disorders | Open-label PTH(1-84) | 4 | 62 | |
| other | Digestive event | Gastrointestinal disorders | Open-label PTH(1-84) | 5 | 62 | |
| other | Endocrine/Nutritional event | Endocrine disorders | Open-label PTH(1-84) | 9 | 62 | |
| other | Infection | General disorders | Open-label PTH(1-84) | 8 | 62 | |
| other | Nervous system event | Nervous system disorders | Open-label PTH(1-84) | 5 | 62 | |
| other | Urinary event | Renal and urinary disorders | Open-label PTH(1-84) | 4 | 62 | |
| serious | Hypercalcemia | Endocrine disorders | Open-label PTH(1-84) | 1 | 62 | 1 |
| serious | Hypocalcemia | Endocrine disorders | Open-label PTH(1-84) | 13 | 62 | 13 |
| serious | Pneumonia | Infections and infestations | Open-label PTH(1-84) | 2 | 62 | 2 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label PTH(1-84) | 0 | 62 |
| Total, other adverse events | Open-label PTH(1-84) | 27 | 62 |
| Total, serious adverse events | Open-label PTH(1-84) | 25 | 62 |
Source ClinicalTrials.gov
Papers14
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 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.
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/NCT01199614
GET https://conductscience.org/api/trials/v1/NCT01199614/registered