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临床试验/NCT05269979
NCT05269979Unknown不适用

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

Kronoberg County Council0 个研究点目标入组 1,248 人开始时间: 2001年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,248
主要终点
Fragility fractures

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
70 Years 至 100 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Fragility fractures

时间窗: Maximum 21 years follow up

Dates

Survival

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

Days

Hip fractures

时间窗: Maximum 21 years follow up

Dates

次要结局

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

研究者

发起方
Kronoberg County Council
申办方类型
Other Gov
责任方
Sponsor

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