Prediction and Secondary Preventing of Fractures in a Norwegian Population. A Substudy of Norwegian Capture the Fracture Initiative
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 840
- Locations
- 6
- Primary Endpoint
- Fragility fractures
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
Outcomes
Primary Outcomes
Fragility fractures
Time Frame: 2 years
Number of new fractures during observation periode
Secondary Outcomes
- Trabecular Bone Score (TBS)(Baseline, 2 years)
- s-PINP(At 1 year follow-up)
- FRAX score(Baseline)
- Garvan score(Baseline)
- s-CTX(At 1 year follow-up)
- Spinal Deformity Index (SDI)(Baseline, 2 years)
- Bone mineral Density (BMD)(Baseline, 2 years)
- Self-reported adherence to anti-osteoporotic drugs (AOD)(Baseline, 1 year, 2 years)
Investigators
Frede Frihagen
Consultant
Oslo University Hospital