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

Postmenopausal Osteoporosis Clinical Trial

— SwOF  

Official title:

Pilot Study on the Epidemiology, Identification Rate and Treatment Penetration of Vertebral Fractures Due to Osteoporosis in Switzerland (SwOF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234414
• Other study ID #: IGO-SwOF 01
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: September 8, 2014
• Start date: February 2009
• Est. completion date: June 2011

Study information

• Verified date: September 2014
• Source: Interessengemeinschaft Osteoporose
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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%.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: June 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 79 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis
• Spinal Fractures

Locations

Country	Name	City	State
Switzerland	Hochgebirgsklinik Davos	Davos-Wolfgang
Switzerland	Kantonsspital Olten	Olten
Switzerland	HFR Tafers	Tafers

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. med. Kurt Lippuner

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of vertebral fractures in community dwelling Swiss women aged 65-79 years		at the only study visit	No
Secondary	Specificity, sensitivity, positive predictive value and negative predictive value for the prediction of underlying vertebral fracture of selected risk factors, clinical signs and vitamin D level, alone or in combination		at the only study visit	No
Secondary	Assessment of the percentage of women correctly identified with a vertebral fracture and adequately treated for underlying osteoporosis and		at the only study visit	No
Secondary	Assessment of the differences between these women and those who are either not correctly diagnosed or not correctly treated		at the only study visit	No