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Clinical Trials/NCT05269979
NCT05269979
Unknown
Not Applicable

Hip Fracture Prevention by Screening and Intervention of Elderly Women in Primary Health Care. 2001 - 2022

Kronoberg County Council0 sites1,248 target enrollmentNovember 2001

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fragility Fracture
Sponsor
Kronoberg County Council
Enrollment
1248
Primary Endpoint
Fragility fractures
Last Updated
4 years ago

Overview

Brief Summary

Researchers plan a 2022 follow-up of medical records data to investigate fracture incidence and survival for 1248 women, born 1902-1931, in a comparative fracture prevention study with 435 participants from an intervention area and 813 participants from two control areas.

In 2022 researchers want to assess patient records data in intervention and control areas and compare A) Survival B) Risk factors for osteoporotic fractures (wrist, upper arm, vertebral, pelvic, hip) C) physical activity, exercise and drugs that affect fracture risk.

Detailed Description

Researchers plan a 2022 follow-up of medical records data to investigate fracture incidence and survival for 1248 women, born 1902-1931, in a comparative fracture prevention study with participants from an intervention area (Vislanda, n=435) and control areas (Emmaboda n=395 and Tingsryd (n=418). Fragility fracture prevalence after 40 years of age was 33% in the 1248 participants with mean age 79 years at baseline 2001. Participants with 2-4 risk factors (age ≥80, body weight \<60kg, previous fragility fracture or impaired rise-up ability) provided prospective data with FRAMO (FRActure and Mortality) Index as an outcome measure and this index identified 80% of hip, fragility fractures or death within a 2-year follow-up period. Hip fracture incidence 2004-2005 was not significantly lower in the intervention area but the trend of the odds ratio (0.33) was in line with significantly fewer falls and improved recovery in the intervention area. In 2022 researchers want to assess patient records data in intervention and control areas and compare A) Survival B) Risk factors for osteoporotic fractures (wrist, upper arm, vertebral, pelvic, hip) C) physical activity, exercise and drugs that affect fracture risk. Data analysis will be blinded for participation in intervention or control groups and statistical methods include Cox regression and Kaplan-Meier's survival analyzes. Birth cohort differences in outcomes will be analysed by using Lexi's diagrams.

Registry
clinicaltrials.gov
Start Date
November 2001
End Date
December 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Kronoberg County Council
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Invitation letter was sent out to all women in three predefined geographical areas of south Sweden born 1902-1931

Exclusion Criteria

  • Participants who themselves or their significant others did not read or understand Swedish were excluded.

Outcomes

Primary Outcomes

Fragility fractures

Time Frame: Maximum 21 years follow up

Dates

Survival

Time Frame: Maximum 21 years of follow up (Participants were on average 79 years old (70 to 100 years) at study start)

Days

Hip fractures

Time Frame: Maximum 21 years follow up

Dates

Secondary Outcomes

  • Time from fragility fractures until death(Maximum 21 years follow up)

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