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Active Not Recruiting NCT07401953

Fracture Risk in Living Kidney Donors

Conditions: Living Kidney Donor, Living Kidney Donation, Fractures, Nephrectomy,Kidney Donation, Fragility Fractures

Sex: All
Ages: 18 Years – 105 Years
Healthy volunteers: Yes
Enrollment: 50000
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Summary

This study will be a population-based, matched retrospective cohort study using linked administrative healthcare databases from Ontario, Alberta, and British Columbia to evaluate the long-term risk of fractures among living kidney donors compared with a healthy cohort of nondonors. Living kidney donors who donated between 1992 and 2024 will be included and matched 1:10 to a carefully selected population of nondonors based on key demographic and clinical characteristics. The primary outcome is a composite of incident hip, femoral shaft, humeral, wrist/forearm, and pelvic fractures. Secondary outcomes will examine each fracture site separately. The results will provide evidence to inform clinical guidelines, support informed decision-making for potential donors and recipients, and guide counselling by transplant clinicians.

Eligibility Criteria

\*Donors\* Inclusion Criteria: Living kidney donors who underwent donor nephrectomy in Ontario, Alberta, and British Columbia, Canada, between July 1, 1992, and March 31, 2024 are eligible to enter the study. Exclusion criteria: * Any person with data errors in their database records (such as missing or invalid age; it is not expected to exclude very few persons for these reasons). Data errors also include evidence of prior dialysis or a prior solid organ transplant, as such individuals are not eligible to become donors. * Any person who was not a permanent resident of the province (i.e., they live outside of the province, and only came to the province to donate a kidney to their intended recipient). This will include anyone who is not eligible for the province's health insurance plan, anyone whose date of last contact in the databases is less than 1 year after the cohort entry date, and any person without a physician visit in the last 1-year. * Any person who is \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07401953). StuddyBuddy aggregates publicly available trial information.