Completed

NCT Number: NCT01998737

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year–79 year

Sex eligibility

Female

Study type

Observational

Primary location

Terveystalo Kamppi, Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis

Time frame: 3 years

The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.
Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis

Time frame: 3 years

The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.

Secondary outcomes

Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis

Time frame: 3 years

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.

Sponsors and collaborators

Lead sponsor

Bone Index Finland Ltd

Industry

Collaborators

Merck Sharp & Dohme LLC

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Dec 2, 2013
Registry last updated: Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed