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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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1248
Est. completion date December 2022
Est. primary completion date December 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 70 Years to 100 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Prevention of hip fractures
Physical exercise and lifestyle advice on diet, smoking, walking and outdoor activities. Recommendations to use calcium and Vitamin D and do exercise at home by written instructions. Home visit by rehab team when needed. Group training with a physiotherapist. Gymnastics group and walking group. Walking aides and instructions of anti-slip protection. Home environment risk reduction was offered.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kronoberg County Council

Outcome

Type Measure Description Time frame Safety issue
Primary Survival Days Maximum 21 years of follow up (Participants were on average 79 years old (70 to 100 years) at study start)
Primary Fragility fractures Dates Maximum 21 years follow up
Primary Hip fractures Dates Maximum 21 years follow up
Secondary Time from fragility fractures until death Days Maximum 21 years follow up
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