- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443566
10-Year Survival After Acute Hip Fracture in Patients With Preclinical/Clinical Alzheimer Pathology
February 25, 2026 updated by: Bengt Nellgård
10-Year Follow-up of Mortality in Patients With Acute Hip Fractures: Associations With Pre-Alzheimer's/Alzheimer's Disease and Cerebrospinal Fluid Biomarkers
This study is a 10-year follow-up of a previously enrolled cohort of patients who underwent surgery for acute hip fracture with spinal anesthesia and had pre-fracture cognitive status assessed (Clinical Dementia Rating, CDR) and cerebrospinal fluid (CSF) biomarkers related to Alzheimer's disease measured (e.g., Aβ42/Aβ40 ratio, total tau, phosphorylated tau).
The primary aim is to determine long-term survival at 10 years after index hip fracture surgery and to evaluate whether baseline cognitive status and/or Alzheimer-type CSF biomarker profiles are associated with long-term mortality.
Study Overview
Status
Completed
Detailed Description
Participants were originally included during admission for acute hip fracture (October 2013-June 2015) at Sahlgrenska University Hospital, Mölndal, Sweden, and underwent lumbar CSF sampling at spinal anesthesia induction.
Cognitive status prior to the fracture was assessed using CDR.
Mortality will be ascertained through Swedish national registries.
The follow-up extends survival assessment to approximately 10 years after surgery.
Analyses will compare survival across baseline cognitive status categories and biomarker-defined groups (e.g., normal vs abnormal Aβ42/Aβ40 ratio), and may adjust for baseline covariates (e.g., age, sex, ASA class / hip fracture risk scores if available from original dataset).
Study Type
Observational
Enrollment (Actual)
404
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Västra Götaland County
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Mölndal, Västra Götaland County, Sweden, 431 80
- Sahlgrenska University Hospit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Older adults (≥65 years) who were admitted for acute hip fracture and underwent surgical repair under spinal anesthesia at Sahlgrenska University Hospital, Mölndal, Sweden.
Participants were originally enrolled between October 2013 and June 2015 and had pre-fracture cognitive status assessed using the Clinical Dementia Rating scale and cerebrospinal fluid biomarkers related to Alzheimer's disease collected at baseline.
The present study is a long-term follow-up of this cohort.
Description
Inclusion Criteria:
- Participant enrolled in the original acute hip fracture cohort (index surgery during Oct 2013-Jun 2015 at Sahlgrenska University Hospital, Mölndal)
- Available personal identity number enabling linkage to Swedish registries
- Baseline cognitive assessment (CDR) and/or CSF biomarker data available from the index admission
Exclusion Criteria:
Missing linkage information preventing ascertainment of vital status
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
All-cause mortality / survival at 10 years after index hip fracture surgery
Time Frame: up to 10 years post-surgery
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up to 10 years post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to death from date of surgery (survival time)
Time Frame: 10 years ( up to 10 years post-surgery)
|
All-cause mortality /survival at 10 years after index hip fracture surgery
|
10 years ( up to 10 years post-surgery)
|
|
Association between baseline CDR category and long-term mortality
Time Frame: up to 10 years
|
up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
February 25, 2026
First Submitted That Met QC Criteria
February 25, 2026
First Posted (Actual)
March 2, 2026
Study Record Updates
Last Update Posted (Actual)
March 2, 2026
Last Update Submitted That Met QC Criteria
February 25, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOFTDEM_10 years
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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