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

• Sponsor: Bone Index Finland Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01998737
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 1,011
• Locations: 6
• Duration (Months): 28
• Patients Per Site: 168.5
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1011 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Women under osteoporosis suspicion
Healthy women

Outcome Measures

Primary Outcome Measures

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

2. Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis [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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 79 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Terveystalo Kamppi	Helsinki		Finland
2	Terveystalo Jyväskylä	Jyväskylä		Finland	40100
3	Terveystalo Kouvola	Kouvola		Finland	45100
4	Kuopio University Hospital	Kuopio		Finland
5	Terveystalo Lahti	Lahti		Finland	15110
6	Terveystalo Mikkeli Marski	Mikkeli		Finland	50100

Sponsors and Collaborators

• Bone Index Finland Ltd
• Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Heikki Kröger, MD, PhD, Kuopio University Hospital
• Study Director: Janne P Karjalainen, PhD, Bone Index Finland Ltd
• Study Director: Ossi Riekkinen, PhD, Bone Index Finland Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bone Index Finland Ltd
• ClinicalTrials.gov Identifier: NCT01998737
• Other Study ID Numbers: Bind03; BoneIndex03
• First Posted: Dec 2, 2013
• Last Update Posted: Sep 21, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Bone Index Finland Ltd: Osteoporosis, diagnostics, ultrasound
• Additional relevant MeSH terms: Osteoporosis

Study Results

Participant Flow

Arm/Group Title	Women Under Osteoporosis Suspicion	Healthy Women
Arm/Group Description	Subjects with at least one risk factor for osteoporotic fracture.	In healthy group females without risk factors for fracture or diseases affecting bone health were recruited.
Period Title: Overall Study
STARTED	911	100
COMPLETED	888	100
NOT COMPLETED	23	0

Baseline Characteristics

Arm/Group Title	Women Under Osteoporosis Suspicion	Healthy Women	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	888	100	988
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	453 51%	74 74%	527 53.3%
>=65 years	435 49%	26 26%	461 46.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.3 (7)	61.6 (6.6)	64.9 (7.0)
Sex: Female, Male (Count of Participants)
Female	888 100%	100 100%	988 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	888 100%	100 100%	988 100%
Region of Enrollment (participants) [Number]
Finland	888 100%	100 100%	988 100%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	64.2 (9.9)	65.5 (9.2)	64.4 (9.9)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	161.5 (6.1)	162.3 (6.1)	161.5 (6.1)

Outcome Measures

1. Primary Outcome

Title	Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis
Description	The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women Under Osteoporosis Suspicion	Healthy Women
Arm/Group Description	As defined in the protocol	As defined in the protocol
Measure Participants	888	100
Number [percentage of true positives]	93.7	100

2. Primary Outcome

Title	Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis
Description	The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women Under Osteoporosis Suspicion	Healthy Women
Arm/Group Description	As defined in the protocol	As defined in the protocol
Measure Participants	888	100
Number [percentage of true negatives]	81.6	93.8

3. Secondary Outcome

Title	Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women Under Osteoporosis Suspicion	Healthy Women
Arm/Group Description	As defined in the protocol	As defined in the protocol
Measure Participants	888	100
Count of Participants [Participants]	288 32.4%	27 27%

Adverse Events

Time Frame	Study duration 3 years
Arm/Group Title	Women Under Osteoporosis Suspicion		Healthy Women
Arm/Group Description
All Cause Mortality
	Women Under Osteoporosis Suspicion		Healthy Women
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Women Under Osteoporosis Suspicion		Healthy Women
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/888 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Women Under Osteoporosis Suspicion		Healthy Women
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/888 (0%)		0/100 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.