Trial · NCT03960554
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
NCT03960554, Phase 2, Terminated, Thomas Nickolas, MD MS; results first posted 2024-07-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients. Trials, record NCT03960554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03960554
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
- NCT number
- NCT03960554
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Thomas Nickolas, MD MS
- Conditions
- Osteoporosis, Renal Osteodystrophy, Kidney Transplant; Complications
- Interventions
- Denosumab Inj 60 mg/ml, Placebo
- First posted
- 2019-05-23
- Last updated
- 2024-07-25
- Results first posted
- 2024-07-25
- Limitations and caveats
- Due to the COVID-19 pandemic, this study was terminated early and no Outcome Measure data was collected from participants.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) | 12 months | BMD will be measured to determine if 1-year of treatment with denosumab changes BMD as measured by DXA. |
| Primary | Estimated Bone Strength Measured by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Imaging | 12 months | Estimated bone mechanical competence will be measured by HR-pQCT. |
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 | Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) | 12 months | Data was not collected due to termination of the study. | ||
| PRIMARY | Estimated Bone Strength Measured by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Imaging | 12 months | Data was not collected due to termination of the study. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Drug | 4 | |
| Overall Study | STARTED | Placebo | 4 | |
| Overall Study | COMPLETED | Active Drug | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Active Drug | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events6
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 | left elbow pain | Musculoskeletal and connective tissue disorders | Active Drug | 0 | 4 | |
| other | left elbow pain | Musculoskeletal and connective tissue disorders | Placebo | 1 | 4 | |
| other | cold sore | Skin and subcutaneous tissue disorders | Active Drug | 0 | 4 | |
| other | cold sore | Skin and subcutaneous tissue disorders | Placebo | 1 | 4 | |
| other | Gastrointestinal Disorder (unspecified) | Gastrointestinal disorders | Active Drug | 1 | 4 | |
| other | Gastrointestinal Disorder (unspecified) | Gastrointestinal disorders | Placebo | 0 | 4 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Drug | 0 | 4 |
| Total, all-cause mortality | Placebo | 0 | 4 |
| Total, other adverse events | Active Drug | 1 | 4 |
| Total, other adverse events | Placebo | 2 | 4 |
| Total, serious adverse events | Active Drug | 0 | 4 |
| Total, serious adverse events | Placebo | 0 | 4 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active Drug vs Placebo: deaths from any cause | Trial comparisons |
| Active Drug vs Placebo: 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/NCT03960554
GET https://conductscience.org/api/trials/v1/NCT03960554/registered