NCT01935232

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 a fracture. We expect with our aging population to see a significant increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and do not receive treatment for their condition. This research plan describes a study for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated in a Finnish postmenopausal woman population of 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral neck bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA. For validation of the technique in US population, our study plan is presented for determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex, lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and 140 men. The study will be carried out at the HealthEast Osteoporosis Care service in Woodbury, MN.

  1. 1.To investigate the capability of DI for prediction of proximal femur and lumbar spine BMD;
  2. 2.To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis is 20%) post-menopausal females (50-90 years);
  3. 3.To investigate ability of Density Index + FRAX with BMI in fracture risk prediction;
  4. 4.To investigate correlation between lumbar spine or proximal femur BMD and Density Index in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or low bone mass. Determine diagnostic thresholds for DI in men.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

August 21, 2013

Last Update Submit

May 16, 2017

Conditions

Osteoporosis

Keywords

Osteoporosis, diagnostics, ultrasound

Outcome Measures

Primary Outcomes (1)

  • Threshold values for DI to reach 90% sensitivity and specificity with the method in diagnostics of Osteoporosis.

    1 year

Secondary Outcomes (1)

  • Amount subjects that can be diagnosed with the established thresholds for DI. Amount of subjects that would require additional examination to verify diagnosis.Correlation between BMD at neck, total hip and lumbar spine with DI.

    1 year

Study Arms (2)

Men

140 Men

Female

500 Female

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

American-Caucasian female (n=500) American-Caucasian men (n=140)

You may qualify if:

  • Postmenopausal women and men referred for bone density examination.

You may not qualify if:

  • Patients unable to sign consent for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthEast Clinic

Saint Paul, Minnesota, 55125, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Christine Simonelli, MD

    HealthEast Osteoporosis Care

    PRINCIPAL INVESTIGATOR

  • Janne P Karjalainen, PhD

    Bone Index Finland Ltd

    STUDY DIRECTOR

  • Ossi Riekkinen, PhD

    Bone Index Finland Ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2013

First Posted

September 5, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

US(1)