Osteoporosis
Conditions
Keywords
Osteoporosis, diagnostics, ultrasound
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Bone Index Finland Ltd
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 79 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Women Under Osteoporosis Suspicion | 888 |
| Healthy Women | 100 |
| Total | 988 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Corrupted database | 23 | 0 |
Baseline characteristics
| Characteristic | Women Under Osteoporosis Suspicion | Healthy Women | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 435 Participants | 26 Participants | 461 Participants |
| Age, Categorical Between 18 and 65 years | 453 Participants | 74 Participants | 527 Participants |
| Age, Continuous | 65.3 years STANDARD_DEVIATION 7 | 61.6 years STANDARD_DEVIATION 6.6 | 64.9 years STANDARD_DEVIATION 7 |
| Height | 161.5 cm STANDARD_DEVIATION 6.1 | 162.3 cm STANDARD_DEVIATION 6.1 | 161.5 cm STANDARD_DEVIATION 6.1 |
| Race/Ethnicity, Customized Caucasian | 888 Participants | 100 Participants | 988 Participants |
| Region of Enrollment Finland | 888 participants | 100 participants | 988 participants |
| Sex: Female, Male Female | 888 Participants | 100 Participants | 988 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 64.2 kg STANDARD_DEVIATION 9.9 | 65.5 kg STANDARD_DEVIATION 9.2 | 64.4 kg STANDARD_DEVIATION 9.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 888 | 0 / 100 |
| serious Total, serious adverse events | 0 / 888 | 0 / 100 |
Outcome results
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women Under Osteoporosis Suspicion | Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis | 93.7 percentage of true positives |
| Healthy Women | Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis | 100 percentage of true positives |
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women Under Osteoporosis Suspicion | Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis | 81.6 percentage of true negatives |
| Healthy Women | Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis | 93.8 percentage of true negatives |
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.
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Women Under Osteoporosis Suspicion | Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis | 288 Participants |
| Healthy Women | Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis | 27 Participants |