NCT06513442

Brief Summary

  1. 1.To assess the clinical utility of trabecular bone score (TBS) on fracture risk prediction including the new version (TBS V4) and future TBS versions at the spine and hip.
  2. 2.To assess the clinical utility of TBS software as a potential treatment outcome: sensitivity to change over time and following osteoporosis therapy.
  3. 3.To compare TBS to other imaging modalities of bone structure such as quantitative computed tomography (QCT) in fracture risk prediction and response to osteoporosis therapy.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
101mo left

Started Aug 2024

Longer than P75 for all trials

Status
not yet recruiting

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 Progress18%
Aug 2024Aug 2034

First Submitted

Initial submission to the registry

July 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2034

Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

10 years

First QC Date

July 17, 2024

Last Update Submit

July 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess the newest version of TBS software on fracture prediction

    10 years

Interventions

To assess the clinical utility of trabecular bone score (TBS) on fracture risk prediction including the new version (TBS V4) and future TBS versions at the spine and hip.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult female and male patients over the age of 18.

You may qualify if:

  • Has had a DEXA scan

You may not qualify if:

  • Unable to complete DEXA scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Claire Mennan, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 22, 2024

Study Start

August 1, 2024

Primary Completion (Estimated)

August 1, 2034

Study Completion (Estimated)

August 1, 2034

Last Updated

July 22, 2024

Record last verified: 2024-07