An observational study in Osteoporotic Fractures, Hip Fractures and Wrist Fractures, sponsored by Oslo University Hospital. Completed at 6 sites in Norway. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-03-04.
Sponsored by Oslo University Hospital · Observational
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.
87 studies on the registry are indexed under Osteoporotic Fractures; 22 are open to participants now.
This study's enrollment of 840 is above the median of 300 across 36 observational studies indexed under Osteoporotic Fractures.
Browse Osteoporotic Fractures studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients already enrolled in NoFRACT main-study. Some patients will be asked to participate in this consent based sub-study, and must be able to answer questionairies, undergo DXA scan and bloodtests at baseline and follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Fragility fractures
Number of new fractures during observation periode
Time frame: 2 years
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
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.
Time frame: 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.
Time frame: Baseline, 1 year, 2 years
Ran from Apr 2015 to primary completion in Dec 2017, 32 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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