Norwegian Capture the Fracture Initiative

Study Overview
=================
Brief Summary
-----------------
The main aim is to assess the effectiveness of introducing a standardized intervention program for treatment of patients with a fragility fracture as measured by changes in the fracture rates and the mortality.

Detailed Description
-----------------
A fracture liaison service model of care is widely recommended but data on its effectiveness regarding reduced risk of recurrent fracture and fracture related mortality are scarce. The investigators therefore aim to assess the risk of subsequent fractures and mortality after a clinical fracture in patients who present to hospitals with a standardized intervention program. Seven Norwegian hospitals will be Stepped Wedge Cluster Randomized to a standardized intervention program with startup date between May 2015 and Jan 2016. The intervention will last throughout 2018 with follow-up throughout 2019. Outcomes before and after the intervention will be compared and each hospital will act as its own control. The effect of the intervention will be measured by using national patient registries on fractures and mortality.

Official Title
-----------------
Norwegian Capture the Fracture Initiative

Conditions
-----------------
Hip Fracture, Vertebral Fracture, Other Low-trauma Fracture

Intervention / Treatment
-----------------
* Other: Fracture Liaison Service
* Other: Current treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low-energy fracture Exclusion Criteria: finger fracture, toe fracture, face fracture, skull fracture

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fracture liaison service<br>Information, assessment & lifestyle advice refer to DXA scan, except patients with dementia, difficulties laying on the back or short life exp. Blood samples Sufficient intake of Vitamin D & calcium, combined with physical activity will be recommended with lifestyle advice (smoking & alcohol intake) Patients With Hip, Vertebral or two or more low-trauma fractures are recommended treated with anti-osteoporosis drug Other fractures, treatment recommended if FRAX score≥20% for major fracture & T-score≤-1.5 Fracture patients with reduced kidney function will be treated with anti-RANKL Anti-osteoporosis drug prescribed by hospital physician Follow-up phone call after 3 months and visit to talk with coordinating nurse after 1 year Patients with spine or femoral neck T-scores≤-3.5, >2 severe vertebral fractures & those who suffer a second fracture while using anti-osteoporosis drug, will be referred for further examination and teriparatide treatment will be considered | Other: Fracture Liaison Service<br> <br> |
| Other: Current treatment<br>Treatment as offered before intervention. | Other: Current treatment<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fragility fracture | Incidence of fragility fractures per 10,000 person-years (distal forearm fractures, proximal humerus fractures and hip fractures) | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Total number of deaths during four years after enrollment | 4 years |