OsteoporosisADVANTAGE BONENCT06513442
The Added Value of Bone Microstructure Assessment in the Management of Osteoporotic Bone
An observational study of Osteoporosis, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
Trial summary
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. To assess the clinical utility of TBS software as a potential treatment outcome: sensitivity to change over time and following osteoporosis… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Trabecular bone score software
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult female and male patients over the age of 18.
Who may be able to join
- Has had a DEXA scan
Who cannot join
- Unable to complete DEXA scan
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- 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.
- To assess the clinical utility of TBS software as a potential treatment outcome: sensitivity to change over time and following osteoporosis therapy.
- 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.
- Conditions
- Osteoporosis
- Being tested
- Trabecular bone score software
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabecular bone score softwareOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the newest version of TBS software on fracture prediction
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2034 (estimated)
- Study completion1 Aug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513442
- Sponsor's protocol ID
- 1.1
- Acronym
- ADVANTAGE BONE
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of Bone Microstructure Assessment in the Management of Osteoporotic Bone
- ClinicalTrials.gov ID
- NCT06513442
- Acronym / sponsor ID
- ADVANTAGE BONE / 1.1
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2034 (estimated)
- Study completion
- 1 Aug 2034 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- To assess the clinical utility of TBS software as a potential treatment outcome: sensitivity to change over time and following osteoporosis therapy.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female and male patients over the age of 18.
Key inclusion criteria (1 listed)
- Has had a DEXA scan
Key exclusion criteria (1 listed)
- Unable to complete DEXA scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trabecular bone score softwareTo 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. | Other | – |
Primary outcome
To assess the newest version of TBS software on fracture prediction
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Mennan, PhD (0169140 ext. 4699, claire.mennan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the newest version of TBS software on fracture prediction (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.