Trial · NCT04026256
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
NCT04026256, Phase 4, Completed, Massachusetts General Hospital; results first posted 2023-08-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration. Trials, record NCT04026256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04026256
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
- NCT number
- NCT04026256
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 37 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Teriparatide, Denosumab
- First posted
- 2019-07-19
- Last updated
- 2023-08-02
- Results first posted
- 2023-08-02
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cancellous Bone Formation Rate at Month 3 | 3 months after first dose of study drug | Cancellous bone formation rate at month 3 is calculated from the cancellous (trabecular) compartment of the iliac crest bone biopsy specimens. Bone formation rate (BFR/BS, mm3/mm2/day): amount of new bone formed in unit time per unit of bone surface. It is calculated by multiplying the mineralizing surface/bone surface (MS/BS) by the mineral apposition rate (MAR) - see below for how MS/BS and MAR are calculated. Mineralizing surface (MS/BS, %): is the percent of bone surface that displays a tetracycline label reflecting active mineralization. It is calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface. It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling. Mineral apposition rate (MAR mm/day): is the mean distance between the double labels, divided by the time interval between them. |
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 | Cancellous Bone Formation Rate at Month 3 | 3 months after first dose of study drug | refers to number of subjects who had bone biopsies available for analysis. | mm3/mm2/day | MEAN |
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 |
|---|---|---|---|---|---|
| Cancellous Bone Formation Rate at Month 3 | Teriparatide Only | 0.13 | Standard Deviation 0.06 | mm3/mm2/day | |
| Cancellous Bone Formation Rate at Month 3 | Denosumab Only | 0.01 | Standard Deviation 0.01 | mm3/mm2/day | |
| Cancellous Bone Formation Rate at Month 3 | Denosumab and Teriparatide | 0.06 | Standard Deviation 0.02 | mm3/mm2/day |
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 Only | 13 | |
| Overall Study | STARTED | Denosumab Only | 9 | |
| Overall Study | STARTED | Denosumab and Teriparatide | 12 | |
| Overall Study | COMPLETED | Teriparatide Only | 10 | |
| Overall Study | COMPLETED | Denosumab Only | 8 | |
| Overall Study | COMPLETED | Denosumab and Teriparatide | 9 | |
| Overall Study | NOT COMPLETED | Teriparatide Only | 3 | |
| Overall Study | NOT COMPLETED | Denosumab Only | 1 | |
| Overall Study | NOT COMPLETED | Denosumab and Teriparatide | 3 |
Source ClinicalTrials.gov
Adverse events33
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 | rhinorrhea | Ear and labyrinth disorders | Teriparatide Only | 2 | 13 | |
| other | rhinorrhea | Ear and labyrinth disorders | Denosumab Only | 1 | 9 | |
| other | rhinorrhea | Ear and labyrinth disorders | Denosumab and Teriparatide | 2 | 12 | |
| other | nausea | Gastrointestinal disorders | Teriparatide Only | 4 | 13 | |
| other | nausea | Gastrointestinal disorders | Denosumab Only | 2 | 9 | |
| other | nausea | Gastrointestinal disorders | Denosumab and Teriparatide | 4 | 12 | |
| other | joint pain | Musculoskeletal and connective tissue disorders | Teriparatide Only | 0 | 13 | |
| other | joint pain | Musculoskeletal and connective tissue disorders | Denosumab Only | 4 | 9 | |
| other | joint pain | Musculoskeletal and connective tissue disorders | Denosumab and Teriparatide | 2 | 12 | |
| other | myalgia | Musculoskeletal and connective tissue disorders | Teriparatide Only | 0 | 13 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide Only | 0 | 13 |
| Total, all-cause mortality | Denosumab Only | 0 | 9 |
| Total, all-cause mortality | Denosumab and Teriparatide | 0 | 12 |
| Total, other adverse events | Teriparatide Only | 5 | 13 |
| Total, other adverse events | Denosumab Only | 6 | 9 |
| Total, other adverse events | Denosumab and Teriparatide | 9 | 12 |
| Total, serious adverse events | Teriparatide Only | 1 | 13 |
| Total, serious adverse events | Denosumab Only | 0 | 9 |
| Total, serious adverse events | Denosumab and Teriparatide | 1 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| R01AR073191 | Mechanisms Underlying the Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration | LEDER, BENJAMIN Z; DEMAY, MARIE | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2019 to 2022 |
Source NIH RePORTER
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/NCT04026256
GET https://conductscience.org/api/trials/v1/NCT04026256/events?page=2