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

NCT01998737 | Completed Results

• 2 other identifiers: Bind03BoneIndex03
• Study Type: observational
• Target: 1,011
• Locations: 1 country
• Sites: 6

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. 1.Cortical bone thickness is decreased in osteoporosis.
2. 2.Patient age, weight and height are related to BMD status and therefore are needed in BMD estimation (Density Index).
3. 3.Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.
4. 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.

Conditions

Osteoporosis

Keywords

Osteoporosis, diagnostics, ultrasound

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  3 years

Study Arms (2)

Women under osteoporosis suspicion

Healthy women

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Treatment: osteoporosis medication.
• Obesity: body mass index BMI \> 30kg/m2
• a refusal to participate in the study
• Healthy
• 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.
• Treatment: osteoporosis medication.
• a refusal to participate in the study
• Obesity: body mass index BMI \> 30kg/m2

Sponsors & Collaborators

• Bone Index Finland Ltd: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

Terveystalo Kamppi

Helsinki, Finland

Location

Terveystalo Jyväskylä

Jyväskylä, 40100, Finland

Location

Terveystalo Kouvola

Kouvola, 45100, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Terveystalo Lahti

Lahti, 15110, Finland

Location

Terveystalo Mikkeli Marski

Mikkeli, 50100, Finland

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: CTO
• Organization: Bone Index Finland Ltd.

janne.karjalainen@boneindex.fi

+358 45 896 2650

Study Officials

• Heikki Kröger, MD, PhD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

• Janne P Karjalainen, PhD

  Bone Index Finland Ltd

  STUDY DIRECTOR

• Ossi Riekkinen, PhD

  Bone Index Finland Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 2, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 21, 2017
• Results First Posted: August 11, 2017

Record last verified: 2017-08

Locations

FI (6)