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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fragility Fracture
• Intervention / Treatment: Behavioral: Prevention of hip fractures

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.

• Study Type: Interventional
• Enrollment (Actual): 1248
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (the Vislanda district); 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.	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.
No Intervention: Control (the Tingsryd/Emmaboda districts); 415 women living in Tingsryd and 395 women living in Emmaboda responded to the same detailed survey as the 435 women living in Vislanda.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Days	Maximum 21 years of follow up (Participants were on average 79 years old (70 to 100 years) at study start)
Fragility fractures	Dates	Maximum 21 years follow up
Hip fractures	Dates	Maximum 21 years follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from fragility fractures until death	Days	Maximum 21 years follow up

Collaborators and Investigators

• Sponsor: Kronoberg County Council

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2001
• Primary Completion (Actual): December 1, 2005
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Osteoporosis
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: LU40600

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No