Norwegian Capture the Fracture Initiative (NoFRACT)

University of Oslo (UIO)

Status: Completed

Conditions: Other Low-trauma Fracture; Hip Fracture; Vertebral Fracture

Treatments: Other: Fracture Liaison Service; Other: Current treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02536898

2015/334

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94,260 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low-energy fracture

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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94,260 participants in 2 patient groups

Fracture liaison service

Experimental group

Description:

* 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

Treatment:

Other: Fracture Liaison Service

Current treatment

Other group

Description:

Treatment as offered before intervention.

Treatment:

Other: Current treatment