Prediction and Secondary Prevention of Fractures

Hip Fractures Clinical Trial

— NOFRACTsub  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608801
• Other study ID #: 2014/2260REK OS
• Status: Completed
• Start date: April 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Fractures, Compression
• Hip Fractures
• Humeral Fractures
• Humeral Fractures, Proximal
• Osteoporotic Fractures
• Shoulder Fractures
• Vertebral Compression Fractures
• Wrist Fractures

Locations

Country	Name	City	State
Norway	Drammen hospital	Drammen
Norway	Molde Hospital	Molde
Norway	Orthopedic Center, Ulleval University Hospital	Oslo
Norway	Baerum Hospital	Sandvika	Gjettum
Norway	University Hospital of North Norway	Tromsø
Norway	St. Olavs Hospital	Trondheim	Trønderlag

Sponsors (9)

Lead Sponsor	Collaborator
Oslo University Hospital	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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fragility fractures	Number of new fractures during observation periode	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	s-CTX	Fasting CTX (carboxy-terminal collagen crosslinks)in serum, measured in pg/ml	At 1 year follow-up
Secondary	s-PINP	Fasting PINP (Procollagen I Intact N-Terminal)in Serum, measured in mcg/L	At 1 year follow-up
Secondary	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
Secondary	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
Secondary	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

External Links

•   NoFRACT