## Protocol Section
### Identification Module
**NCT ID:** NCT05269979

**Acronym:** HIP22

**Brief Title:** Hip Fracture Prevention Follow-up of Elderly Women in Primary Health Care

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

#### Organization Study ID Info
**ID:** LU40600
#### Organization
**Class:** OTHER_GOV
**Full Name:** Kronoberg County Council
### Status Module
#### Completion Date
**Date:** 2022-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2022-03-08

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-25

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2005-12

**Type:** ACTUAL

#### Start Date
**Date:** 2001-11

**Type:** ACTUAL

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2022-03-08
**Type:** ACTUAL
**Study First Submit Date:** 2022-02-05
**Study First Submit QC Date:** 2022-02-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Kronoberg County Council

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Fragility Fracture

**Keywords:**

- Osteoporosis

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1248

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Behavioral: Prevention of hip fractures

**Label:** Intervention (the Vislanda district)

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Label:** Control (the Tingsryd/Emmaboda districts)

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention (the Vislanda district)

**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.

**Name:** Prevention of hip fractures

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Days

**Measure:** Survival

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

**Description:** Dates

**Measure:** Fragility fractures

**Time Frame:** Maximum 21 years follow up

**Description:** Dates

**Measure:** Hip fractures

**Time Frame:** Maximum 21 years follow up

#### Secondary Outcomes

**Description:** Days

**Measure:** Time from fragility fractures until death

**Time Frame:** Maximum 21 years follow up

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 100 Years

**Minimum Age:** 70 Years

**Sex:** FEMALE

**Standard Ages:**

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000005264

- Term: Femoral Fractures

- ID: D000025981

- Term: Hip Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

- ID: M9696

- Name: Hip Fractures

- Relevance: HIGH

- As Found: Hip Fracture

- ID: M12947

- Name: Osteoporosis

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M8402

- Name: Femoral Fractures

- Relevance: LOW

- As Found: Unknown

- ID: M23105

- Name: Hip Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050723

- Term: Fractures, Bone

- ID: D000006620

- Term: Hip Fractures

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: LOW

- As Found: Unknown

- ID: M6003

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: T442

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: T479

- Name: Vitamin D3

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
