Osteoporosis Clinical Trial
Official title:
Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
Verified date | August 2017 |
Source | Bone Index Finland Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 1011 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 79 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Finland | Terveystalo Kamppi | Helsinki | |
Finland | Terveystalo Jyväskylä | Jyväskylä | |
Finland | Terveystalo Kouvola | Kouvola | |
Finland | Kuopio University Hospital | Kuopio | |
Finland | Terveystalo Lahti | Lahti | |
Finland | Terveystalo Mikkeli Marski | Mikkeli |
Lead Sponsor | Collaborator |
---|---|
Bone Index Finland Ltd | Merck Sharp & Dohme Corp. |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 3 years | |
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. | 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. | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06287502 -
Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
|
N/A | |
Completed |
NCT03822078 -
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
|
Phase 1 | |
Recruiting |
NCT05845021 -
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
|
N/A | |
Completed |
NCT00092066 -
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
|
Phase 3 | |
Recruiting |
NCT04754711 -
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
|
N/A | |
Completed |
NCT04736693 -
Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
|
||
Completed |
NCT02922478 -
Role of Comorbidities in Chronic Heart Failure Study
|
||
Recruiting |
NCT02635022 -
Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
|
||
Recruiting |
NCT02616627 -
Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
|
||
Active, not recruiting |
NCT02617303 -
Prevention of Falls and Its Consequences in Elderly People
|
N/A | |
Completed |
NCT02566655 -
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
|
Phase 1 | |
Completed |
NCT02559648 -
Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis
|
Phase 2 | |
Completed |
NCT03420716 -
Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women
|
N/A | |
Not yet recruiting |
NCT02223572 -
Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture
|
N/A | |
Completed |
NCT02003716 -
DeFRA Questionnaire as an Anamnestic Form
|
N/A | |
Not yet recruiting |
NCT01854086 -
Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday
|
N/A | |
Unknown status |
NCT01913834 -
Nasally and sc Administered Teriparatide in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A | |
Completed |
NCT01401556 -
C-STOP Fracture Trial
|
N/A | |
Completed |
NCT02143674 -
Muscle Strengthening Exercises and Global Stretching in Elderly
|
N/A |