Trial · NCT01656629
Stem Cell Recruitment in Osteoporosis Therapy
NCT01656629, Not applicable, Terminated, Johns Hopkins University; results first posted 2019-08-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stem Cell Recruitment in Osteoporosis Therapy. Trials, record NCT01656629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01656629
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stem Cell Recruitment in Osteoporosis Therapy
- NCT number
- NCT01656629
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 55 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Low Bone Density
- Interventions
- Teriparatide, Alendronate, calcium and vitamin D
- First posted
- 2012-08-03
- Last updated
- 2020-08-21
- Results first posted
- 2019-08-08
- Limitations and caveats
- There was a high level of variability and this data has not been validated.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN). | up to 3 months | |
| Secondary | Difference in Bone Formation as Assessed by Bone Histomorphometry on Bone Biopsy Between Treatment Groups | 3 months | |
| Secondary | Difference in Osteogenic Potential of Bone Marrow as Measure by Colony Forming Unit Osteoblast (CFU-Ob) Assays Between Treatment Groups | 3 months |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN). | up to 3 months | percent change in osteoprogenitor cells | MEAN | |
| SECONDARY | Difference in Bone Formation as Assessed by Bone Histomorphometry on Bone Biopsy Between Treatment Groups | 3 months | Collected bone biopsy samples were not analyzed and no data was generated. Therefore data was not collected. | ||
| SECONDARY | Difference in Osteogenic Potential of Bone Marrow as Measure by Colony Forming Unit Osteoblast (CFU-Ob) Assays Between Treatment Groups | 3 months | Collected osteoblast assay samples were not analyzed and no data was generated. Therefore data was not collected. |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN). | Teriparatide | 0.0000242 | Standard Deviation 0.0000283 | percent change in osteoprogenitor cells | |
| The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN). | Alendronate | 0.0000104 | Standard Deviation 0.0000231 | percent change in osteoprogenitor cells | |
| The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN). | Calcium and Vitamin D | -0.0000068 | Standard Deviation 0.0000449 | percent change in osteoprogenitor cells |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriparatide | 21 | |
| Overall Study | STARTED | Alendronate | 18 | |
| Overall Study | STARTED | Calcium and Vitamin D | 16 | |
| Overall Study | COMPLETED | Teriparatide | 16 | |
| Overall Study | COMPLETED | Alendronate | 16 | |
| Overall Study | COMPLETED | Calcium and Vitamin D | 14 | |
| Overall Study | NOT COMPLETED | Teriparatide | 5 | |
| Overall Study | NOT COMPLETED | Alendronate | 2 | |
| Overall Study | NOT COMPLETED | Calcium and Vitamin D | 2 |
Source ClinicalTrials.gov
Adverse events9
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 | Nausea | Gastrointestinal disorders | Teriparatide | 1 | 21 | 1 |
| other | Nausea | Gastrointestinal disorders | Alendronate | 0 | 18 | 0 |
| other | Nausea | Gastrointestinal disorders | Calcium and Vitamin D | 0 | 16 | 0 |
| other | Dizziness | Nervous system disorders | Teriparatide | 1 | 21 | 1 |
| other | Dizziness | Nervous system disorders | Alendronate | 0 | 18 | 0 |
| other | Dizziness | Nervous system disorders | Calcium and Vitamin D | 0 | 16 | 0 |
| other | Gastrointestinal bleeding | Gastrointestinal disorders | Teriparatide | 0 | 21 | 0 |
| other | Gastrointestinal bleeding | Gastrointestinal disorders | Alendronate | 0 | 18 | 0 |
| other | Gastrointestinal bleeding | Gastrointestinal disorders | Calcium and Vitamin D | 1 | 16 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide | 0 | 21 |
| Total, all-cause mortality | Alendronate | 0 | 18 |
| Total, all-cause mortality | Calcium and Vitamin D | 0 | 16 |
| Total, other adverse events | Teriparatide | 2 | 21 |
| Total, other adverse events | Alendronate | 0 | 18 |
| Total, other adverse events | Calcium and Vitamin D | 1 | 16 |
| Total, serious adverse events | Teriparatide | 0 | 21 |
| Total, serious adverse events | Alendronate | 0 | 18 |
| Total, serious adverse events | Calcium and Vitamin D | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01656629
GET https://conductscience.org/api/trials/v1/NCT01656629/registered