Norwegian Capture the Fracture Initiative (NoFRACT)

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.

Study Overview

• Status: Completed
• Conditions: Hip Fracture; Vertebral Fracture; Other Low-trauma Fracture
• Intervention / Treatment: Other: Fracture Liaison Service; Other: Current treatment

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 Type: Interventional
• Enrollment (Actual): 94260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital
  • Drammen, Norway
    • Drammen Hospital
  • Molde, Norway
    • Molde Hospital
  • Oslo, Norway
    • Oslo University Hospital
  • Sandvika, Norway
    • Bærum Hospital
  • Tromsø, Norway
    • University Hospital of North Norway
  • Trondheim, Norway
    • St. Olavs University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Low-energy fracture

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Fracture Liaison Service
Other: Current treatment; Treatment as offered before intervention.	Other: Current treatment

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; University Hospital of North Norway; Norwegian University of Science and Technology; Asker & Baerum Hospital; Haukeland University Hospital; St. Olavs Hospital; Molde Hospital; Drammen sykehus
• Investigators: Study Director: Lars Nordsletten, PhD, Oslo University Hospital

Publications and helpful links

General Publications

• Andreasen C, Solberg LB, Basso T, Borgen TT, Dahl C, Wisloff T, Hagen G, Apalset EM, Gjertsen JE, Figved W, Hubschle LM, Stutzer JM, Elvenes J, Joakimsen RM, Syversen U, Eriksen EF, Nordsletten L, Frihagen F, Omsland TK, Bjornerem A. Effect of a Fracture Liaison Service on the Rate of Subsequent Fracture Among Patients With a Fragility Fracture in the Norwegian Capture the Fracture Initiative (NoFRACT): A Trial Protocol. JAMA Netw Open. 2018 Dec 7;1(8):e185701. doi: 10.1001/jamanetworkopen.2018.5701.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Hip Fractures; Spinal Fractures; Osteoporotic Fractures
• Other Study ID Numbers: 2015/334