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Hip Fracture Prevention Follow-up of Elderly Women in Primary Health Care (HIP22)

Primary Purpose

Fragility Fracture

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prevention of hip fractures
Sponsored by
Kronoberg County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fragility Fracture focused on measuring Osteoporosis

Eligibility Criteria

70 Years - 100 Years (Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention (the Vislanda district)

    Control (the Tingsryd/Emmaboda districts)

    Arm Description

    435 women living in Vislanda responded to a detailed survey and participated in physical exercise and received 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.

    415 women living in Tingsryd and 395 women living in Emmaboda responded to the same detailed survey as the 435 women living in Vislanda.

    Outcomes

    Primary Outcome Measures

    Survival
    Days
    Fragility fractures
    Dates
    Hip fractures
    Dates

    Secondary Outcome Measures

    Time from fragility fractures until death
    Days

    Full Information

    First Posted
    February 5, 2022
    Last Updated
    February 25, 2022
    Sponsor
    Kronoberg County Council
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05269979
    Brief Title
    Hip Fracture Prevention Follow-up of Elderly Women in Primary Health Care
    Acronym
    HIP22
    Official Title
    Hip Fracture Prevention by Screening and Intervention of Elderly Women in Primary Health Care. 2001 - 2022
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    November 2001 (Actual)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kronoberg County Council

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fragility Fracture
    Keywords
    Osteoporosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1248 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention (the Vislanda district)
    Arm Type
    Experimental
    Arm Description
    435 women living in Vislanda responded to a detailed survey and participated in physical exercise and received 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.
    Arm Title
    Control (the Tingsryd/Emmaboda districts)
    Arm Type
    No Intervention
    Arm Description
    415 women living in Tingsryd and 395 women living in Emmaboda responded to the same detailed survey as the 435 women living in Vislanda.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Prevention of hip fractures
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Survival
    Description
    Days
    Time Frame
    Maximum 21 years of follow up (Participants were on average 79 years old (70 to 100 years) at study start)
    Title
    Fragility fractures
    Description
    Dates
    Time Frame
    Maximum 21 years follow up
    Title
    Hip fractures
    Description
    Dates
    Time Frame
    Maximum 21 years follow up
    Secondary Outcome Measure Information:
    Title
    Time from fragility fractures until death
    Description
    Days
    Time Frame
    Maximum 21 years follow up

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    70 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Hip Fracture Prevention Follow-up of Elderly Women in Primary Health Care

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