Fracture Risk in Living Kidney Donors

NCT07401953 | Completed

• 1 other identifier: 2021 0906 443 002
• Study Type: observational
• Target: 50,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Living Kidney Donor; Living Kidney Donation; Fractures; Nephrectomy,Kidney Donation; Fragility Fractures

Outcome Measures

Primary Outcomes (1)

• Fragility fracture

  Hospital admission, emergency department visit, and/or billing receipt for a fragility fractures, defined as a composite of hip, femur, humerus, wrist/forearm, and pelvis.

  Donors and their matched non-donors will enter the cohort between July 1, 1992 and March 31, 2024, and will be followed until study outcome (first event), death, emigration from the province, or the end of the observation period (March 31, 2025).

Secondary Outcomes (1)

• Each fragility fracture type/location

  Donors and their matched non-donors will enter the cohort between July 1, 1992 and March 31, 2024, and will be followed until study outcome (first event), death, emigration from the province, or the end of the observation period (March 31, 2025).

Other Outcomes (1)

• Spinal/vertebral fragility fractures

  Donors and their matched non-donors will enter the cohort between July 1, 1992 and March 31, 2024, and will be followed until study outcome (first event), death, emigration from the province, or the end of the observation period (March 31, 2025).

Study Arms (2)

Living kidney donor cohort

Living kidney donors who had a laparoscopic nephrectomy between July 1, 1992 and March 31, 2024, at transplant centres in the provinces of Ontario, Alberta, and British Columbia. Each nephrectomy date will serve as their cohort entry date.

Procedure: Nephrectomy

Healthy non-donor cohort

A similarly healthy segment of the general provinical population selected using restriction and matching to emulate the health criteria required to be met for living kidney donation. A cohort entry date (simulated nephrectomy date) will be randomly assigned to all residents in the province, according to the distribution of cohort entry dates among donors (between July 1, 1992 and March 31, 2024).

Interventions

Nephrectomy PROCEDURE

Receipt of a nephrectomy for living kidney donation

Living kidney donor cohort

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Living kidney donors matched to nondonors from the general population with similar indicators of baseline health.

You may not qualify if:

• 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 \<18 years of age on the date of nephrectomy (as only under exceptional circumstances should a person less than 18 be approved for living donation).
• Any person with data errors in their database records (such as missing or invalid age).
• Any person who was not a permanent resident of the province. 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.
• Any person who is \<18 years of age on the cohort entry date.
• Anyone who is pregnant at the time of index date.
• Baseline illnesses and measures of healthcare access from historic records preceding the cohort entry date will be identified. Restriction will then be used on the sample of eligible non-donors to persons without a recorded medical condition that could preclude donation. Such recorded medical conditions will include a hospitalization for mental illness in the prior year; an intensive care unit admission in the prior year; a hospitalization for palliative care services in the prior year; multiple hospital admissions in the prior year; high comorbidity (as assessed by the Charlson comorbidity index and adjusted clinical group scores); receipt of home oxygen therapy; residence at a long-term care facility; dementia; any record of prior nephrology consultation or kidney disease (including receipt of dialysis, a kidney biopsy, or a kidney procedure such as a partial or complete nephrectomy); previous solid organ transplant; disorders of the kidneys, ureters, or bladder; any record of cardiovascular disease (congestive heart failure, cardiovascular procedures, myocardial infarction, peripheral vascular disease, abdominal aortic aneurysm repair, ischemic stroke); hypertension in individuals \<50 years of age (persons with this condition are not accepted as donors in Ontario); any record of obstructive sleep apnea; any cancer diagnosis; any liver disease or cirrhosis; diabetes; any serious infection (hepatitis, HIV, infective endocarditis); any record of autoimmune rheumatic conditions (such as rheumatoid arthritis or systemic lupus erythematosus); and any record of alcoholism.
• To ensure the nondonors have the same opportunity as donors to obtain health care services from physicians, nondonors who had no evidence of a family physician visit in the 2 years prior to the index will be excluded. Nondonors with more than 5 family physician visits in the 2 years prior to the index will also be excluded, as this could suggest they have an active health issue that needs attention before they would proceed to donate.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Related Publications (8)

• Garg AX, Pouget J, Young A, Huang A, Boudville N, Hodsman A, Adachi JD, Leslie WD, Cadarette SM, Lok CE, Monroy-Cuadros M, Prasad GV, Thomas SM, Naylor K, Treleavan D; Donor Nephrectomy Outcomes Research (DONOR) Network. Fracture risk in living kidney donors: a matched cohort study. Am J Kidney Dis. 2012 Jun;59(6):770-6. doi: 10.1053/j.ajkd.2012.01.013. Epub 2012 Apr 1.

  PMID: 22472209 BACKGROUND

• Nickolas TL, McMahon DJ, Shane E. Relationship between moderate to severe kidney disease and hip fracture in the United States. J Am Soc Nephrol. 2006 Nov;17(11):3223-32. doi: 10.1681/ASN.2005111194. Epub 2006 Sep 27.

  PMID: 17005938 BACKGROUND

• Ibrahim HN, Rogers T, Tello A, Matas A. The performance of three serum creatinine-based formulas in estimating GFR in former kidney donors. Am J Transplant. 2006 Jun;6(6):1479-85. doi: 10.1111/j.1600-6143.2006.01335.x.

  PMID: 16686774 BACKGROUND

• Garg AX, Muirhead N, Knoll G, Yang RC, Prasad GV, Thiessen-Philbrook H, Rosas-Arellano MP, Housawi A, Boudville N; Donor Nephrectomy Outcomes Research (DONOR) Network. Proteinuria and reduced kidney function in living kidney donors: A systematic review, meta-analysis, and meta-regression. Kidney Int. 2006 Nov;70(10):1801-10. doi: 10.1038/sj.ki.5001819. Epub 2006 Sep 27.

  PMID: 17003822 BACKGROUND

• Fried LF, Biggs ML, Shlipak MG, Seliger S, Kestenbaum B, Stehman-Breen C, Sarnak M, Siscovick D, Harris T, Cauley J, Newman AB, Robbins J. Association of kidney function with incident hip fracture in older adults. J Am Soc Nephrol. 2007 Jan;18(1):282-6. doi: 10.1681/ASN.2006050546. Epub 2006 Dec 13.

  PMID: 17167115 BACKGROUND

• Ensrud KE, Lui LY, Taylor BC, Ishani A, Shlipak MG, Stone KL, Cauley JA, Jamal SA, Antoniucci DM, Cummings SR; Osteoporotic Fractures Research Group. Renal function and risk of hip and vertebral fractures in older women. Arch Intern Med. 2007 Jan 22;167(2):133-9. doi: 10.1001/archinte.167.2.133.

  PMID: 17242313 BACKGROUND

• Dukas L, Schacht E, Stahelin HB. In elderly men and women treated for osteoporosis a low creatinine clearance of <65 ml/min is a risk factor for falls and fractures. Osteoporos Int. 2005 Dec;16(12):1683-90. doi: 10.1007/s00198-005-1903-7. Epub 2005 Jun 3.

  PMID: 15933802 BACKGROUND

• Dooley AC, Weiss NS, Kestenbaum B. Increased risk of hip fracture among men with CKD. Am J Kidney Dis. 2008 Jan;51(1):38-44. doi: 10.1053/j.ajkd.2007.08.019.

  PMID: 18155531 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Interventions

Nephrectomy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 11, 2026
• Study Start: July 1, 1992
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: February 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share