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Prediction and Secondary Prevention of Fractures (NOFRACTsub)

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Completed

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT02608801
2014/2260REK OS

Details and patient eligibility

About

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.

Full 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.

Enrollment

840 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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,

Trial design

840 participants in 1 patient group

Patients from NoFRACT
Description:
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.

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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