Trial · NCT04313634
Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans
NCT04313634, Phase 2, Completed, Sundeep Khosla, M.D.; results first posted 2024-07-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans. Trials, record NCT04313634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04313634
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans
- NCT number
- NCT04313634
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- Sundeep Khosla, M.D.
- Conditions
- Healthy
- Interventions
- Dasatinib, Quercetin, Fisetin
- First posted
- 2020-03-18
- Last updated
- 2024-07-22
- Results first posted
- 2024-07-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in C-terminal Telopeptide of Type I Collagen [CTX] | Baseline, 20 weeks | Percent change in serum bone turnover markers C-terminal telopeptide of type I collagen \[CTX\]. The C-terminal telopeptide (CTX), also known as carboxy-terminal collagen crosslinks, is a biomarker used to measure the rate of bone turnover. It provides valuable information for assessing bone health and evaluating treatment responses. |
| Secondary | Change in Bone Turnover Markers | Baseline, 2 weeks | Percent change in amino-terminal propeptide of type I collagen (P1NP). The P1NP assay measures the serum concentration of the amino-terminal propeptide of type I procollagen (P1NP). As the concentration of this extension propeptide is directly proportional to the amount of new collagen laid down in bone, it can be used to assess bone formation. |
| Secondary | Change in Bone Turnover Markers | Baseline, 4 weeks | Percent change in amino-terminal propeptide of type I collagen (P1NP). The P1NP assay measures the serum concentration of the amino-terminal propeptide of type I procollagen (P1NP). As the concentration of this extension propeptide is directly proportional to the amount of new collagen laid down in bone, it can be used to assess bone formation. |
| Secondary | Change in Bone Turnover Markers | Baseline, 20 weeks | Percent change in amino-terminal propeptide of type I collagen (P1NP). The P1NP assay measures the serum concentration of the amino-terminal propeptide of type I procollagen (P1NP). As the concentration of this extension propeptide is directly proportional to the amount of new collagen laid down in bone, it can be used to assess bone formation. |
| Secondary | Change in Bone Mineral Density (BMD) | Baseline, 20 weeks | Percent change in BMD by dual-energy X-ray absorptiometry (DXA) at the lumbar spine, hip ((total and femoral neck (FN), and radius (total and ultra-distal)). |
| Secondary | Change in Plasma Senescence-associated Secretory Phenotype (SASP) | Baseline, 2 weeks | Percent change in SASP cells (representing the total senescence cell burden) present. Assessment of senescence markers in bone at baseline and 2 weeks. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in C-terminal Telopeptide of Type I Collagen [CTX] | Baseline, 20 weeks | percent change | MEDIAN | |
| SECONDARY | Change in Bone Turnover Markers | Baseline, 2 weeks | percentage change of P1NP | MEDIAN | |
| SECONDARY | Change in Bone Turnover Markers | Baseline, 4 weeks | Outcome measure was only collected and reported for Dasatinib plus Quercetin Treatment arm and Untreated Control group arm | percentage change of P1NP | MEDIAN |
| SECONDARY | Change in Bone Turnover Markers | Baseline, 20 weeks | percentage change of P1NP | MEDIAN | |
| SECONDARY | Change in Bone Mineral Density (BMD) | Baseline, 20 weeks | Each skeletal site was measured and assessed separately. As such, some sites (which are influenced by osteoarthritis) did not provide interpretable scans. This occurred due to motion artifacts or other issues. Therefore, the number of participants analyzed differ by skeletal site. | percentage of change in BMD | MEDIAN |
| SECONDARY | Change in Plasma Senescence-associated Secretory Phenotype (SASP) | Baseline, 2 weeks | percent change | MEDIAN |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in C-terminal Telopeptide of Type I Collagen [CTX] | Dasatinib Plus Quercetin Treatment Goup | -4.1 | Full Range -28.1 to 114.6 | percent change | |
| Change in C-terminal Telopeptide of Type I Collagen [CTX] | Fisetin Treatment Group | 13.7 | Full Range -42.7 to 61.0 | percent change | |
| Change in C-terminal Telopeptide of Type I Collagen [CTX] | Untreated Control Group | -7.7 | Full Range -42.4 to 22.5 | percent change | |
| Change in Bone Turnover Markers | Dasatinib Plus Quercetin Treatment Goup | 0.8 | Full Range -39.6 to 113.5 | percentage change of P1NP | |
| Change in Bone Turnover Markers | Fisetin Treatment Group | -31.9 | Full Range -74.0 to 23.3 | percentage change of P1NP | |
| Change in Bone Turnover Markers | Untreated Control Group | -15.2 | Full Range -55.0 to 59.8 | percentage change of P1NP | |
| Change in Bone Turnover Markers | Dasatinib Plus Quercetin Treatment Goup | 4.2 | Full Range -61.4 to 1480 | percentage change of P1NP | |
| Change in Bone Turnover Markers | Untreated Control Group | -12.1 | Full Range -58.0 to 95.9 | percentage change of P1NP | |
| Change in Bone Turnover Markers | Dasatinib Plus Quercetin Treatment Goup | -8.6 | Full Range -48.1 to 130.9 | percentage change of P1NP | |
| Change in Bone Turnover Markers | Fisetin Treatment Group | 4.5 | Full Range -34.8 to 29.7 | percentage change of P1NP |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib Plus Quercetin Treatment Goup | 30 | |
| Overall Study | STARTED | Fisetin Treatment Group | 14 | |
| Overall Study | STARTED | Untreated Control Group | 30 | |
| Overall Study | COMPLETED | Dasatinib Plus Quercetin Treatment Goup | 27 | |
| Overall Study | COMPLETED | Fisetin Treatment Group | 12 | |
| Overall Study | COMPLETED | Untreated Control Group | 28 | |
| Overall Study | NOT COMPLETED | Dasatinib Plus Quercetin Treatment Goup | 3 | |
| Overall Study | NOT COMPLETED | Fisetin Treatment Group | 2 | |
| Overall Study | NOT COMPLETED | Untreated Control Group | 2 |
Source ClinicalTrials.gov
Adverse events129
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 | Abdominal distention | Gastrointestinal disorders | Dasatinib Plus Quercetin Treatment Goup | 0 | 30 | 0 |
| other | Abdominal distention | Gastrointestinal disorders | Fisetin Treatment Group | 1 | 14 | 1 |
| other | Abdominal distention | Gastrointestinal disorders | Untreated Control Group | 0 | 30 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Dasatinib Plus Quercetin Treatment Goup | 0 | 30 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Fisetin Treatment Group | 1 | 14 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Untreated Control Group | 0 | 30 | 0 |
| other | Constipation | Gastrointestinal disorders | Dasatinib Plus Quercetin Treatment Goup | 3 | 30 | 3 |
| other | Constipation | Gastrointestinal disorders | Fisetin Treatment Group | 1 | 14 | 1 |
| other | Constipation | Gastrointestinal disorders | Untreated Control Group | 0 | 30 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Dasatinib Plus Quercetin Treatment Goup | 7 | 30 | 14 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib Plus Quercetin Treatment Goup | 0 | 30 |
| Total, all-cause mortality | Fisetin Treatment Group | 0 | 14 |
| Total, all-cause mortality | Untreated Control Group | 0 | 30 |
| Total, other adverse events | Dasatinib Plus Quercetin Treatment Goup | 23 | 30 |
| Total, other adverse events | Fisetin Treatment Group | 12 | 14 |
| Total, other adverse events | Untreated Control Group | 5 | 30 |
| Total, serious adverse events | Dasatinib Plus Quercetin Treatment Goup | 0 | 30 |
| Total, serious adverse events | Fisetin Treatment Group | 1 | 14 |
| Total, serious adverse events | Untreated Control Group | 0 | 30 |
Source ClinicalTrials.gov
Papers2
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 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/NCT04313634
GET https://conductscience.org/api/trials/v1/NCT04313634/results?page=2