Norwegian Capture the Fracture Initiative

Not Applicable

Completed

• Conditions: Other Low-trauma Fracture; Vertebral Fracture; Hip Fracture
• Interventions: Other: Fracture Liaison Service; Other: Current treatment

• Registration Number: NCT02536898
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2015-04-30
• Study Start: 2015-05
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-01
• Primary Completion: 2020-01
• Study Completion: 2020-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94260

Inclusion Criteria

• Low-energy fracture

Exclusion Criteria

• finger fracture, toe fracture, face fracture, skull fracture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fracture liaison service	Fracture Liaison Service	* 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
Current treatment	Current treatment	Treatment as offered before intervention.

Primary Outcome Measures

Name	Time	Method
Fragility fracture	4 years	Incidence of fragility fractures per 10,000 person-years (distal forearm fractures, proximal humerus fractures and hip fractures)

Secondary Outcome Measures

Name	Time	Method
Mortality	4 years	Total number of deaths during four years after enrollment

Trial Locations

Locations (7)

Oslo University Hospital; 🇳🇴 Oslo, Norway

Drammen Hospital; 🇳🇴 Drammen, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Molde Hospital; 🇳🇴 Molde, Norway

Bærum Hospital; 🇳🇴 Sandvika, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

St. Olavs University Hospital; 🇳🇴 Trondheim, Norway