Epidemiology, Identification Rate and Treatment Penetration of Osteoporotic Vertebral Fractures in Switzerland

NCT ID: NCT02234414

Last Updated: 2014-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 303 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-06-30

Brief Summary

In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown and the published data from the Swiss hospitals statistics represent only the tip of the iceberg. In addition, the percentages of women correctly identified with vertebral fractures due to osteoporosis and the treatment rate of these women with a drug proven to reduce the risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of vertebral fractures differs between urban and rural areas or between mountain areas and plain country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in physical activity and/ or dietary habits.

Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a combination of both would improve sensitivity and specificity is unknown.

The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a retrospective study of hospitalized elderly patients has shown that as many as 50% of the radiographic reports failed to note the presence of moderate to severe vertebral fractures. In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment was offered to only 36% of the diagnosed patients.

The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA measurements allows for the detection of vertebral deformities, which is critical for management of osteoporosis, as the existence of such deformities substantially increases the risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between 90-94%.

Detailed Description

Examinations

• Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
• Aged 65-79 yrs
• Written informed consent

Conditions

Postmenopausal Osteoporosis; Spinal Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
• Aged 65-79 yrs
• Written informed consent

Exclusion Criteria

• Patients who underwent spine surgery
• Not willing or not able to sign informed consent
• In patients not willing or not able to participate, the reason for denial will be recorded for future evaluation.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. med. Kurt Lippuner

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Kurt Lippuner

President

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kurt Lippuner, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Interessengemeinschaft Osteoporose

Locations

Kantonsspital Olten

Olten, , Switzerland

HFR Tafers

Tafers, , Switzerland

Hochgebirgsklinik Davos

Wolfgang, , Switzerland

Countries

Switzerland

Other Identifiers

IGO-SwOF 01

Identifier Type: -

Identifier Source: org_study_id