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| ID | Type | Description | Link |
|---|---|---|---|
| BoneIndex03 | Other Identifier | Bone Index Finland Ltd. |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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:
The following procedures will be applied
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women under osteoporosis suspicion | |||
| Healthy women |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Alcohol intake 3 or more units daily
Causes of secondary osteoporosis:
A Physician has referred the woman to axial DXA investigation.
Exclusion Criteria:
Healthy
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Terveystalo Kamppi | Helsinki | Finland | ||||
| Terveystalo Jyväskylä |
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| ID | Title | Description |
|---|---|---|
| FG000 | Women Under Osteoporosis Suspicion | Subjects with at least one risk factor for osteoporotic fracture. |
| FG001 | Healthy Women | In healthy group females without risk factors for fracture or diseases affecting bone health were recruited. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Women Under Osteoporosis Suspicion | |
| BG001 | Healthy Women | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of true positives | 3 years |
|
Study duration 3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women Under Osteoporosis Suspicion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CTO | Bone Index Finland Ltd. | +358 45 896 2650 | janne.karjalainen@boneindex.fi |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| Jyväskylä |
| 40100 |
| Finland |
| Terveystalo Kouvola | Kouvola | 45100 | Finland |
| Kuopio University Hospital | Kuopio | Finland |
| Terveystalo Lahti | Lahti | 15110 | Finland |
| Terveystalo Mikkeli Marski | Mikkeli | 50100 | Finland |
Total of all reporting groups
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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. | Posted | Number | percentage of true negatives | 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. | Posted | Count of Participants | Participants | 3 years |
|
|
|
| 0 |
| 888 |
| 0 |
| 888 |
| EG001 | Healthy Women | 0 | 100 | 0 | 100 |
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| D009750 |
| Nutritional and Metabolic Diseases |