NCT03878732

Brief Summary

Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients 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. Bindex ultrasound device has been developed and validated in Caucasian female population. In this study, diagnostic thresholds for density index as determined with Bindex will be evaluated in two different ethnic populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
293

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 11, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

March 15, 2019

Last Update Submit

April 30, 2020

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of DI

    Sensitivity and specificity of DI in caucasian and hispanic groups

    3/11/2019-11/29/2019

Study Arms (2)

Caucasian female

Diagnostic Test: Bindex measurement

Hispanic female

Diagnostic Test: Bindex measurement

Interventions

Bindex measurementDIAGNOSTIC_TEST

One time bone density measurement with ultrasound device

Caucasian femaleHispanic female

Eligibility Criteria

Age50 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsReview history. No genetic testing shall be done or confirmation of external sexual organs.Transgender individuals will not be included in the study population.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Random sample of eligible female subjects who are being treated at collaborating clinic.

You may qualify if:

  • Postmenopausal status
  • Age at 50 years or over
  • Caucasian or Hispanic race (number shall be controlled, 140 in each group)
  • Body mass index (BMI \< 35)
  • Additional criteria for Osteoporotic group
  • \- T-Score (NHANES database) -2.5 or lower at femoral neck or total femur
  • Additional criteria for non-osteoporotic group
  • \- T-Score (NHANES database) \> -2.5 at femoral neck or total femur

You may not qualify if:

  • for non-osteoporotic groups (Hispanic or Caucasian)
  • Previous osteoporosis diagnosis
  • Previous or current use of anti-fracture medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Mexico Clincial Research & Osteoporosis Center, Inc.

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Janne Karjalainen

    Bone Index Finland Ltd

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 18, 2019

Study Start

March 11, 2019

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

May 1, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)