NCT05269979

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2001

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
16.2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

4.1 years

First QC Date

February 5, 2022

Last Update Submit

February 25, 2022

Conditions

Keywords

Osteoporosis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Time from fragility fractures until death

    Maximum 21 years follow up

Study Arms (2)

Intervention (the Vislanda district)

EXPERIMENTAL

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

Control (the Tingsryd/Emmaboda districts)

NO INTERVENTION

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

Interventions

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.

Intervention (the Vislanda district)

Eligibility Criteria

Age70 Years - 100 Years
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2022

First Posted

March 8, 2022

Study Start

November 1, 2001

Primary Completion

December 1, 2005

Study Completion

December 1, 2022

Last Updated

March 8, 2022

Record last verified: 2022-02