Prediction and Secondary Prevention of Fractures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prediction and Secondary Preventing of Fractures in a Norwegian Population. A Substudy of Norwegian Capture the Fracture Initiative

Conditions
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Osteoporotic Fractures, Hip Fractures, Wrist Fractures, Ankle Fractures, Vertebral Compression Fractures, Humeral Fractures, Proximal

Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients from NoFRACT<br>Patients from NoFRACT who consent to participate in this sub-study, will be offered examination and treatment with anti-osteoporotic drugs cf. treatment algorithm in the main-study. I.e. if osteoporosis is present clinically or at DXA scan, treatment is started. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fragility fractures | Number of new fractures during observation periode | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral Density (BMD) | BMD in g/cm2 measured by DXA at both hips and lumbar spine. We want to study if there is a correlation between BMD an incidence of new fractures | Baseline, 2 years | 
| Trabecular Bone Score (TBS) | TBS is an absolute value calculated from the DXA scans of L1-L4. We want to see if TBS can be used as a predictor of future fractures | Baseline, 2 years | 
| Spinal Deformity Index (SDI) | Grading of vertebral fractures (SQ1=1 point, SQ2 =2 points, SQ3= 3 points) by Vertebral Fracture Assessment of lateral DXA scans. The total of points is the SDI. We want to see if there is a correlation between present fractures at baseline and future fractures | Baseline, 2 years | 
| s-CTX | Fasting CTX (carboxy-terminal collagen crosslinks)in serum, measured in pg/ml | At 1 year follow-up | 
| s-PINP | Fasting PINP (Procollagen I Intact N-Terminal)in Serum, measured in mcg/L | At 1 year follow-up | 
| FRAX score | Calculation 10-year fracture risk for major osteoporotic and hip fractures by FRAX calculated during DXA scanning, on a population treated with AOD | Baseline | 
| Garvan score | Calculation of 10-year fracture risk for major osteoporotic and hip fracture using online available Garvan Nomogram, on a population treated with AOD. | Baseline | 
| Self-reported adherence to anti-osteoporotic drugs (AOD) | Self-reported use of AOD by questionnaire. Answer yes or no. If terminating of the treatment, patients will be asked to describe why. | Baseline, 1 year, 2 years |