Tier 2 — strong

Targeting Cellular Senescence With Senolytics to Improve Skeletal Health in Older Humans

Sundeep Khosla, M.D. (study sponsor/investigator)
ClinicalTrials.gov (completed Phase 2 trial with posted results) 2024 NCT04313634; results first posted 22 July 2024

Bibliography

Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Sponsor listed as Sundeep Khosla, M.D.; ClinicalTrials.gov funder type: OTHER. Study conducted at Mayo Clinic in Rochester, Minnesota.
Competing interests
ClinicalTrials.gov registry record does not provide a journal-style competing-interests declaration.

Study snapshot

DesignPhase 2 randomized parallel interventional trial; open-label (masking: none), primary purpose supportive care.
ModelAdult and older women without a disease condition, studied for skeletal-health and cellular-senescence outcomes.
Sample74 participants enrolled.
InterventionRandomized senolytic intervention study including dasatinib, quercetin and fisetin arms; dosing details should be interpreted from the registered protocol/results rather than extrapolated from other fisetin trials.
DurationOutcomes assessed through 20 weeks; study ran from 9 June 2020 to 6 June 2023.
EndpointsPrimary: percent change in serum CTX from baseline to 20 weeks; P1NP bone-formation marker at weeks 2, 4 and 20; Bone mineral density by DXA at 20 weeks; Plasma senescence-associated secretory phenotype at 2 weeks

What the study showed, in plain terms

This completed Phase 2 Mayo Clinic trial tested whether senolytic interventions, including fisetin, could change bone-turnover, bone-density and senescence-related measures in older women.

The registry contains posted results, which makes it more informative than an ongoing trial listing, but it is still not a peer-reviewed journal publication. The fisetin evidence should therefore be treated as preliminary human trial evidence and interpreted from the registered arm-specific results rather than summarized as proof of a skeletal-health benefit.

Key findings

  • The trial was randomized, Phase 2, completed, and enrolled 74 women.
  • Primary outcome was percent change in the bone-resorption marker CTX at 20 weeks.
  • Secondary outcomes included P1NP, DXA bone mineral density and circulating SASP measures.

What this study can and cannot tell us

  • Registry results are not equivalent to a peer-reviewed journal report and provide less contextual interpretation of arm-specific findings.
  • Female-only sample and modest enrollment limit generalizability.
  • The study included multiple senolytic interventions, so fisetin-specific conclusions require careful arm-level interpretation and should not be inferred from overall trial design alone.

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Editorial review

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology