Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01439139
Other study ID # BUSS-04
Secondary ID 2R44AG017400
Status Completed
Phase N/A
First received September 21, 2011
Last updated March 27, 2014
Start date September 2011
Est. completion date May 2013

Study information

Verified date March 2014
Source Artann Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.


Description:

Study will conduct measurements in a group of postmenopausal women and use their DXA examination data as a control. BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria:

- Postmenopausal

- Age 50-90 years

- Any race or ethnicity

- DXA spine and hip exam within one year

Exclusion Criteria:

- Open wounds or rashes on the testing area

- Active skin infection

- Recent tibia surgery

- Abnormal tibia anatomy

- Body Mass Index > 34.9 kg/m2

- Current or previous tibial fracture on side of testing

- Stroke or with total or partial paralysis with residual disability lasting more than 3 months

Current or recent (within past 6 months) use of bone-active drugs:

- Bisphosphonates

- Calcitonin

- Estrogens or selective estrogen receptor modulator (SERM)

- Therapeutic doses of fluoride (> 2mg/day)

- Teriparatide used currently or within past 3 months

- Drugs under research protocols, and

- Unstudied or unapproved drugs

- Presence of metabolic bone disease

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Catholic Health System Affiliates & Sister's of Charity Hospital Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
Artann Laboratories National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements. 1 year No
See also
  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
Not yet recruiting NCT06431867 - Primary Care Management of Osteoporosis in Older Women
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
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Completed NCT03420716 - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women N/A
Unknown status NCT01913834 - Nasally and sc Administered Teriparatide in Healthy Volunteers Phase 1
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
Completed NCT02003716 - DeFRA Questionnaire as an Anamnestic Form N/A
Completed NCT02143674 - Muscle Strengthening Exercises and Global Stretching in Elderly N/A
Completed NCT01401556 - C-STOP Fracture Trial N/A