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

Fragility Fracture Clinical Trial

— HIP22  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05269979
• Other study ID #: LU40600
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fragility Fracture
• Hip Fractures

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