Clinical trial NCT01998737: Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
Official title: Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Osteoporosis, diagnostics, ultrasound
Lead sponsor: Bone Index Finland Ltd
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-12-02
Enrollment: 1011
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Women for the under osteoporosis suspicion group will be invited from those who have got a referral for DXA examination from their doctor.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis
timeFrame: 3 years
measure: Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis
timeFrame: 3 years
Secondary outcomes:
measure: Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis
timeFrame: 3 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Terveystalo Kamppi
city: Jyväskylä
country: Finland
facility: Terveystalo Jyväskylä
city: Kouvola
country: Finland
facility: Terveystalo Kouvola
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Lahti
country: Finland
facility: Terveystalo Lahti
city: Mikkeli
country: Finland
facility: Terveystalo Mikkeli Marski
Study officials:
affiliation: Kuopio University Hospital
name: Heikki Kröger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bone Index Finland Ltd
name: Janne P Karjalainen, PhD
role: STUDY_DIRECTOR
affiliation: Bone Index Finland Ltd
name: Ossi Riekkinen, PhD
role: STUDY_DIRECTOR
References: