Trial · NCT01279187
The Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone
NCT01279187, Phase 2, Terminated, University of Michigan; results first posted 2018-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone. Trials, record NCT01279187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01279187
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone
- NCT number
- NCT01279187
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Implant
- Interventions
- Teriparatide, Placebo
- First posted
- 2011-01-19
- Last updated
- 2018-02-07
- Results first posted
- 2018-02-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bone Formation Rate | 10 weeks | To determine the impact of PTH on bone quality and bone turnover in the oral cavity. The primary outcome variable will be bone formation rate. |
| Secondary | Bone Turnover (Mineral Apposition Rates) | 10 weeks | Bone turnover was assessed indirectly by bone histomorphometry using the following abbreviations: Mineral Apposition Rate (MAR): Distance between 2 fluorochrome markers that comprise a double label on the surfaces of cancellous bone measured at an average of 4 equally-spaced sites per double label. These measurements will be performed on 20 double fluorochrome labels per bone and the average divided by the time between the midpoints of the two labeling periods. MAR serves as an index of osteoblast activity. Reported for cancellous (Cn), endocortical (Ec) at baseline (pre-drug intervention, listed as "first set") and at the end of drug intervention ("second set"). "First set" refers to baseline information (pre-drug), and "second set" refers to data evaluated at the end of the drug administration phase. Periosteal (Ps) data and Ec.Mar Endocortical MAR "second set" was reviewed but no analyzable labeling was noted and so this data is not reported. |
| Secondary | Bone Turnover: Cortical Tissue Area | 10 weeks | Bone turnover was assessed indirectly by evaluating cellular parameters of PTH action (i.e. numbers of osteoblasts, osteoclasts, apoptotic osteoblasts). The methods used to obtain the outcomes described below were bone histomorphometry using the following abbreviation: Ct.T.Ar: Ct Cort(ex)(ical) Tissue Area (2D)b "First set" refers to baseline pre-drug data and "second set" was taken at the end of the drug administration phase. |
| Secondary | Bone Turnover: Bone Perimeter Length | 10 weeks | Bone histomorphometry was used to assess bone perimeter length in mm as follows: Cn.Pm cancellous: Cancellous Bone Perimeter Ec.Pm: endocortical bone perimeter Ps.Pm: Periosteal Periosteal bone perimeter |
| Secondary | Bone Turnover: Bone Percentages | 10 weeks | Oc.S/BS cancellous: Osteoclast suface divided by bone surface. Osteoclastic surface as percent of total bone surface in cancellous bone. Percent cancellous bone perimeter with osteoclasts (large, multinuclear, TRAP positive cells). OS/BS cancellous: Osteoid surface divided by bone surface. Percentage of cancellous bone perimeter covered with osteoid. Oc.S/BS endocortical: Osteoclastic surface as percent of total bone surface in endocortical bone. OS/BS endocortical: Percentage of endocortical bone perimeter covered with osteoid. Oc.S/BS Periosteal: Osteoclastic surface as percent of total bone surface in periosteal bone. Ob.S/BS Periosteal: Percent periosteal bone perimeter with osteoid and adjacent osteoblasts, identified as plump cells with a single, eccentric nucleus and a pale-staining golgi apparatus. Osteoblast Surface divided by bone surface in periosteal bone. OS/BS Periosteal: Percentage of periosteal bone perimeter covered with osteoid. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bone Formation Rate | 10 weeks | mm2/week | MEDIAN | |
| SECONDARY | Bone Turnover (Mineral Apposition Rates) | 10 weeks | um/day | MEAN | |
| SECONDARY | Bone Turnover: Cortical Tissue Area | 10 weeks | mm2/week | MEAN | |
| SECONDARY | Bone Turnover: Bone Perimeter Length | 10 weeks | mm | MEAN | |
| SECONDARY | Bone Turnover: Bone Percentages | 10 weeks | percentage (%) | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bone Formation Rate | Teriparatide | 1.76 | Standard Deviation 0.99 | mm2/week | |
| Bone Formation Rate | Control | 2.22 | Standard Deviation 1.67 | mm2/week | |
| Bone Turnover (Mineral Apposition Rates) | Teriparatide | Cn.MAR (Cancellous MAR) - first set | 0.5 | Standard Deviation 0.1 | um/day |
| Bone Turnover (Mineral Apposition Rates) | Control | Cn.MAR (Cancellous MAR) - first set | 0.3 | Standard Deviation 0.2 | um/day |
| Bone Turnover (Mineral Apposition Rates) | Teriparatide | Ec.MAR Endocortical MAR - first set | 0.7 | Standard Deviation 0.7 | um/day |
| Bone Turnover (Mineral Apposition Rates) | Control | Ec.MAR Endocortical MAR - first set | 0.6 | Standard Deviation 0.4 | um/day |
| Bone Turnover (Mineral Apposition Rates) | Teriparatide | Cn.MAR Cancellous MAR- second set | 0.2 | Standard Deviation 0.2 | um/day |
| Bone Turnover (Mineral Apposition Rates) | Control | Cn.MAR Cancellous MAR- second set | 0.3 | Standard Deviation 0.2 | um/day |
| Bone Turnover: Cortical Tissue Area | Teriparatide | Ct.T.Ar first set Cortical Tissue Area | 2.2 | Standard Deviation 1.6 | mm2/week |
| Bone Turnover: Cortical Tissue Area | Control | Ct.T.Ar first set Cortical Tissue Area | 1.8 | Standard Deviation 1 | mm2/week |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriparatide | 14 | |
| Overall Study | STARTED | Control | 13 | |
| Overall Study | COMPLETED | Teriparatide | 14 | |
| Overall Study | COMPLETED | Control | 13 | |
| Overall Study | NOT COMPLETED | Teriparatide | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events30
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 | Debonded Crown | General disorders | Teriparatide | 3 | 14 | 4 |
| other | Debonded Crown | General disorders | Control | 8 | 13 | 13 |
| other | Implant Failure | General disorders | Teriparatide | 4 | 14 | 4 |
| other | Implant Failure | General disorders | Control | 6 | 13 | 6 |
| other | Thrush | General disorders | Teriparatide | 1 | 14 | 1 |
| other | Thrush | General disorders | Control | 0 | 13 | 0 |
| other | Shingles | General disorders | Teriparatide | 0 | 14 | 0 |
| other | Shingles | General disorders | Control | 1 | 13 | 1 |
| other | Sore Throat | General disorders | Teriparatide | 1 | 14 | 2 |
| other | Sore Throat | General disorders | Control | 0 | 13 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide | 0 | 14 |
| Total, all-cause mortality | Control | 0 | 13 |
| Total, other adverse events | Teriparatide | 12 | 14 |
| Total, other adverse events | Control | 11 | 13 |
| Total, serious adverse events | Teriparatide | 0 | 14 |
| Total, serious adverse events | Control | 0 | 13 |
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 |
|---|---|
| Teriparatide vs Control: deaths from any cause | Trial comparisons |
| Teriparatide vs Control: 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/NCT01279187
GET https://conductscience.org/api/trials/v1/NCT01279187/results?page=2