Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05269979 |
Other study ID # |
LU40600 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 2001 |
Est. completion date |
December 2022 |
Study information
Verified date |
February 2022 |
Source |
Kronoberg County Council |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.