Trial · NCT00086619
Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
NCT00086619, Phase 2, Completed, Massachusetts General Hospital; results first posted 2013-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women. Trials, record NCT00086619. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00086619
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
- NCT number
- NCT00086619
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Postmenopausal Osteoporosis, Osteoporosis
- Interventions
- synthetic hPTH 1-34
- First posted
- 2004-07-08
- Last updated
- 2013-10-30
- Results first posted
- 2013-09-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Indices of Bone Turnover | Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18. | Change from month 0 (pre-treatment) baseline serum aminoterminal propeptide of type I collagen (PINP), osteocalcin (OC), and C-terminal telopeptide (CTX), expressed as an area under the curve (AUC). Each marker measurement result was multiplied by the corresponding subject-specific elapsed study time interval using the trapezoidal rule, and these products were summed to generate a subject-specific AUC (months\*ng/ml) for the marker. |
| Secondary | Change in Bone Mineral Density (BMD) | baseline and 18 months (12 months in 4 subjects) | Percent change in BMD of the spine, femur, radius, and ulna, and subtotal body, calculated as 100\*\[(final - month 0)/month 0\] in subjects who took study therapy for at least 12 months. |
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 | Changes in Indices of Bone Turnover | Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18. | Because this was a physiologic study evaluating the impact of stepwise increases in teriparatide, per protocol analysis was performed as was pre-specified in our analysis plan. Outcomes data were analyzed in women who remained on teriparatide throughout the first stepwise increase (i.e. until month 12 or later). | months*(ng/ml - baseline ng/ml) | MEAN |
| SECONDARY | Change in Bone Mineral Density (BMD) | baseline and 18 months (12 months in 4 subjects) | Final BMD was measured after 18 months of study therapy in 48 subjects and measured after 12 months of study therapy in 4 others who thereafter dropped out prematurely. Of the latter 4, 3 were in the ascending dose arm and 1 was in the constant dose arm. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Indices of Bone Turnover | Constant Dose PTH | PINP | 4418 | Standard Deviation 2732 | months*(ng/ml - baseline ng/ml) |
| Changes in Indices of Bone Turnover | Ascending Dose PTH | PINP | 3696 | Standard Deviation 1735 | months*(ng/ml - baseline ng/ml) |
| Changes in Indices of Bone Turnover | Constant Dose PTH | OC | 956 | Standard Deviation 416 | months*(ng/ml - baseline ng/ml) |
| Changes in Indices of Bone Turnover | Ascending Dose PTH | OC | 822 | Standard Deviation 312 | months*(ng/ml - baseline ng/ml) |
| Changes in Indices of Bone Turnover | Constant Dose PTH | CTX | 22 | Standard Deviation 11 | months*(ng/ml - baseline ng/ml) |
| Changes in Indices of Bone Turnover | Ascending Dose PTH | CTX | 19 | Standard Deviation 9 | months*(ng/ml - baseline ng/ml) |
| Change in Bone Mineral Density (BMD) | Constant Dose PTH | 1/3 Radius BMD | -4.6 | Standard Deviation 2.8 | percent change |
| Change in Bone Mineral Density (BMD) | Ascending Dose PTH | 1/3 Radius BMD | -3.1 | Standard Deviation 3.3 | percent change |
| Change in Bone Mineral Density (BMD) | Constant Dose PTH | Femoral neck BMD | 1.7 | Standard Deviation 3.0 | percent change |
| Change in Bone Mineral Density (BMD) | Ascending Dose PTH | Femoral neck BMD | 3.5 | Standard Deviation 2.7 | percent change |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Constant Dose PTH | 40 | |
| Overall Study | STARTED | Ascending Dose PTH | 40 | |
| Overall Study | Completed Baseline Visit | Constant Dose PTH | 34 | |
| Overall Study | Completed Baseline Visit | Ascending Dose PTH | 36 | |
| Overall Study | Completed 12 Month Visit | Constant Dose PTH | 26 | |
| Overall Study | Completed 12 Month Visit | Ascending Dose PTH | 26 | |
| Overall Study | COMPLETED | Constant Dose PTH | 25 | |
| Overall Study | COMPLETED | Ascending Dose PTH | 23 | |
| Overall Study | NOT COMPLETED | Constant Dose PTH | 15 | |
| Overall Study | NOT COMPLETED | Ascending Dose PTH | 17 |
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 | Mild hypercalcemia or hypercalciuria | Endocrine disorders | Constant Dose PTH | 3 | 40 | 3 |
| other | Mild hypercalcemia or hypercalciuria | Endocrine disorders | Ascending Dose PTH | 5 | 40 | 5 |
| other | Joint pain | Musculoskeletal and connective tissue disorders | Constant Dose PTH | 0 | 40 | 0 |
| other | Joint pain | Musculoskeletal and connective tissue disorders | Ascending Dose PTH | 1 | 40 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Constant Dose PTH | 0 | 40 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Ascending Dose PTH | 1 | 40 | 1 |
| other | Nausea | Gastrointestinal disorders | Constant Dose PTH | 1 | 40 | 1 |
| other | Nausea | Gastrointestinal disorders | Ascending Dose PTH | 1 | 40 | 1 |
| other | Lower extremity edema | Blood and lymphatic system disorders | Constant Dose PTH | 1 | 40 | 1 |
| other | Lower extremity edema | Blood and lymphatic system disorders | Ascending Dose PTH | 0 | 40 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Constant Dose PTH | ||
| Total, all-cause mortality | Ascending Dose PTH | ||
| Total, other adverse events | Constant Dose PTH | 5 | 40 |
| Total, other adverse events | Ascending Dose PTH | 8 | 40 |
| Total, serious adverse events | Constant Dose PTH | 0 | 40 |
| Total, serious adverse events | Ascending Dose PTH | 2 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21111078 | RESULT |
Source PubMed
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50AR044855 | Specialized Center for Research in Osteoporosis | KRONENBERG, HENRY M | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 1997 to 2005 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Constant Dose PTH vs Ascending Dose PTH: serious adverse events |
Source 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/NCT00086619
GET https://conductscience.org/api/trials/v1/NCT00086619/registered