Prediction and Secondary Prevention of Fractures

Oslo University Hospital840 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

840

Conditions

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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,

Locations (6)

Baerum Hospital

Sandvika, Gjettum, Norway

St. Olavs Hospital

Trondheim, Trønderlag, Norway

Drammen hospital

Drammen, Norway

Molde Hospital

Molde, Norway

Outcomes

Primary Outcomes

Fragility fractures

Number of new fractures during observation periode

Time frame: 2 years

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Baseline, 2 years

s-CTX

Fasting CTX (carboxy-terminal collagen crosslinks)in serum, measured in pg/ml

Time frame: At 1 year follow-up

s-PINP

Fasting PINP (Procollagen I Intact N-Terminal)in Serum, measured in mcg/L

Time frame: 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

Time frame: Baseline

Data from ClinicalTrials.gov

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