Clinical trial NCT05269979: Hip Fracture Prevention Follow-up of Elderly Women in Primary Health Care
Official title: Hip Fracture Prevention by Screening and Intervention of Elderly Women in Primary Health Care. 2001 - 2022
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fragility Fracture
Keywords: Osteoporosis
Lead sponsor: Kronoberg County Council
Sponsor class: OTHER_GOV
First posted: 2022-03-08
Enrollment: 1248
Sex: FEMALE
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Survival
timeFrame: Maximum 21 years of follow up (Participants were on average 79 years old (70 to 100 years) at study start)
measure: Fragility fractures
timeFrame: Maximum 21 years follow up
measure: Hip fractures
timeFrame: Maximum 21 years follow up
Secondary outcomes:
measure: Time from fragility fractures until death
timeFrame: Maximum 21 years follow up
Other outcomes:
Locations:
Study officials:
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