Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX

Osteoporosis Clinical Trial

Official title:

Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998737
• Other study ID #: Bind03
• Secondary ID: BoneIndex03
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: August 18, 2017
• Start date: November 2013
• Est. completion date: March 2016

Study information

• Verified date: August 2017
• Source: Bone Index Finland Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after several fractures. Furthermore, the progressively aging population will increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and does not receive treatment for their condition.

In this study we aim to investigate the strength of Density Index (DI) for prediction of proximal femur and lumbar spine BMD as well as determining the diagnostic thresholds for DI for osteoporosis diagnostics by using the International Society for Clinical Densitometry guidelines. In addition we aim to investigate how many additional women would be identified for osteoporosis diagnosis/ treatment based on adding FRAX to Bindex versus adding FRAX to DXA.

The investigators will start and organize a multicenter study in 5 osteoporosis clinics in Suomen Terveystalo Healthcare Service Company in Finland. A total of 1100 postmenopausal women (age 50 -79 years) will be measured with both axial DXA and Bindex. In addition, the FRAX questioinnaire will be asked from everybody attending the study.

Clinical hypotheses:

1. Cortical bone thickness is decreased in osteoporosis.

2. Patient age, weight and height are related to BMD status and therefore are needed in BMD estimation (Density Index).

3. Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.

4. Fracture risk factors (FRAX) and point-of-care bone density measurement together have significantly higher sensitivity and specificity for osteoporosis/treatment decisions than one method alone.

Description:

The following procedures will be applied

• Signing Informed Consent

• Filling in the FRAX questionnaire

• DXA measurements of the proximal femur and AP spine

• Bindex ultrasound measurement of both the tibia and the radius

Written informed consent is obtained from all subjects before enrolment to the study. All patient data is coded, i.e. made anonymous, to conform to personal data protection. The data is processed only for study purposes.

A total of 1100 postmenopausal women (age 50 -79 years) will participate the study. The subjects will be divided into two groups: healthy (100 women) and under osteoporosis suspicion (1000 women). The groups will be matched by BMI.

Written informed consent is obtained from all subjects before enrolment in the study. All patient data is coded, i.e. made anonymous, to conform to personal data protection. The data is processed only for study purposes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1011
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 79 Years

Eligibility

Osteoporosis suspicion

Inclusion Criteria:

• Age: 50 - 59 years (n = 500) and 60-79 years (n = 500).

• Post-menopausal status.

• At least one of the clinical risk factors for fracture:

• Low body mass index (< 19kg/m2)

• Previous fragility fracture

• Parental history of hip fracture

• Glucocorticoid treatment (= 5mg prednisolone daily or equivalent for 3 months or more)

• Current smoking

• Alcohol intake 3 or more units daily

• Causes of secondary osteoporosis:

• Untreated hypogonadism

• Inflammatory bowel disease

• Prolonged immobility

• Organ transplantation

• Type 1 and type 2 diabetes

• Thyroid disorders

• Chronic obstructive pulmonary disease

• A Physician has referred the woman to axial DXA investigation.

Exclusion Criteria:

• Treatment: osteoporosis medication.

• Obesity: body mass index BMI > 30kg/m2

• a refusal to participate in the study

Healthy

Inclusion Criteria:

• Age: 50 - 59 years (n = 50) and 60-79 years (n = 50).

• Post-menopausal status.

• No diseases or treatments which may affect to bone health.

Exclusion Criteria:

• Treatment: osteoporosis medication.

• a refusal to participate in the study

• Obesity: body mass index BMI > 30kg/m2

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
Finland	Terveystalo Kamppi	Helsinki
Finland	Terveystalo Jyväskylä	Jyväskylä
Finland	Terveystalo Kouvola	Kouvola
Finland	Kuopio University Hospital	Kuopio
Finland	Terveystalo Lahti	Lahti
Finland	Terveystalo Mikkeli Marski	Mikkeli

Sponsors (2)

Lead Sponsor	Collaborator
Bone Index Finland Ltd	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis	The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.	3 years
Primary	Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis	The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.	3 years
Secondary	Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis	The previously determined thresholds have been applied. The results show amount of subject whose DI value is between the thresholds. These subjects would need DXA measurement to verify diagnosis.	3 years