Clinical trial NCT02608801: Prediction and Secondary Prevention of Fractures
Official title: Prediction and Secondary Preventing of Fractures in a Norwegian Population. A Substudy of Norwegian Capture the Fracture Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporotic Fractures
Hip Fractures
Wrist Fractures
Ankle Fractures
Vertebral Compression Fractures
Humeral Fractures, Proximal
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Asker & Baerum Hospital
name: Drammen sykehus
name: Haukeland University Hospital
name: Molde Hospital
name: Norwegian University of Science and Technology
name: St. Olavs Hospital
name: University Hospital of North Norway
name: University of Oslo
First posted: 2015-11-20
Enrollment: 840
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients already enrolled in NoFRACT main-study. Some patients will be asked to participate in this consent based sub-study, and must be able to answer questionairies, undergo DXA scan and bloodtests at baseline and follow-up.

Brief summary: The purpose of this study is to investigate patient related factors that contribute to increased risk of recurrent fractures and to investigate patient adherence to prescribed anti-osteoporotic drugs.

Detailed description: A standardized treatment program of osteoporosis will be introduced successively at 7 hospitals in Norway from April 2015 to January 2016. This Project is named NoFRACT (Norwegian Capture the Fracture Initiative https://clinicaltrials.gov/show/NCT02536898). Patients above 50 years of age, who recently have suffered a fragility fracture, will be offered examination of osteoporosis and treatment if indicated. Some of these patients will be asked to participate in this consent-based sub-study (NoFRACTsub). At baseline, the patients will be asked to answer a questionnaire, collect blood-sample for to outline possible causes for osteoporosis, in addition to Dual X-Ray Apsopiometry (DXA) scan including bone mineral density(BMD), trabecular bone score(TBS) and vertebral fracture assessment (VFA). At 1-year follow-up there will be a brief questionnaire and measuring of BTM. At 2-year follow-up there will be a brief questionnaire in addition to repeated measurement of DXA including BMD, TBS and VFA. All data will be stored securly at the designated server at the University of Oslo, Service of sensitive data, TSD.

Eligibility criteria: Inclusion Criteria:

* Patients participating in NoFRACT
* Recent low-trauma vertebral or non-vertebral fracture
* Written patient consent

Exclusion Criteria:

* Fractures of scull, face, toes or fingers
* Short life expectancy
* Patients not competent or willing to give consent
* Patients having difficulties in answering questionairies, undergoing a DXA scan, and show up on the follow-ups,

Primary outcomes:
measure: Fragility fractures
timeFrame: 2 years
Secondary outcomes:
measure: Bone mineral Density (BMD)
timeFrame: Baseline, 2 years
measure: Trabecular Bone Score (TBS)
timeFrame: Baseline, 2 years
measure: Spinal Deformity Index (SDI)
timeFrame: Baseline, 2 years
measure: s-CTX
timeFrame: At 1 year follow-up
measure: s-PINP
timeFrame: At 1 year follow-up
measure: FRAX score
timeFrame: Baseline
measure: Garvan score
timeFrame: Baseline
measure: Self-reported adherence to anti-osteoporotic drugs (AOD)
timeFrame: Baseline, 1 year, 2 years
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Baerum Hospital
state: Gjettum
city: Trondheim
country: Norway
facility: St. Olavs Hospital
state: Trønderlag
city: Drammen
country: Norway
facility: Drammen hospital
city: Molde
country: Norway
facility: Molde Hospital
city: Oslo
country: Norway
facility: Orthopedic Center, Ulleval University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: The Arctic University of Norway
name: Åshild Bjørnerem, Dr Med
role: STUDY_DIRECTOR
References: