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Completed

NCT Number: NCT02608801

Prediction and Secondary Prevention of Fractures

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.

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Key information

Conditions

Osteoporotic Fractures Ankle Fractures Ankle Injuries Arm Injuries Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Humeral Fractures, Proximal Leg Injuries Shoulder Fractures Shoulder Injuries Vertebral Compression Fractures Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baerum Hospital, Sandvika, Gjettum, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Primary outcomes

  1. Fragility fractures

    Time frame: 2 years

    Number of new fractures during observation periode

Secondary outcomes

  1. Bone mineral Density (BMD)

    Time frame: Baseline, 2 years

    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

  2. Trabecular Bone Score (TBS)

    Time frame: Baseline, 2 years

    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

  3. Spinal Deformity Index (SDI)

    Time frame: Baseline, 2 years

    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

  4. s-CTX

    Time frame: At 1 year follow-up

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

  5. s-PINP

    Time frame: At 1 year follow-up

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

  6. FRAX score

    Time frame: Baseline

    Calculation 10-year fracture risk for major osteoporotic and hip fractures by FRAX calculated during DXA scanning, on a population treated with AOD

  7. Garvan score

    Time frame: Baseline

    Calculation of 10-year fracture risk for major osteoporotic and hip fracture using online available Garvan Nomogram, on a population treated with AOD.

  8. Self-reported adherence to anti-osteoporotic drugs (AOD)

    Time frame: Baseline, 1 year, 2 years

    Self-reported use of AOD by questionnaire. Answer yes or no. If terminating of the treatment, patients will be asked to describe why.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Asker & Baerum Hospital
  • Drammen sykehus
  • Haukeland University Hospital
  • Molde Hospital
  • Norwegian University of Science and Technology
  • St. Olavs Hospital
  • University Hospital of North Norway
  • University of Oslo

Registry information

Official study title

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

Acronym: NOFRACTsub

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Nov 20, 2015
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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