OsteoporosisTEOBASONCT04253340
Study of a Bone Assessment Technique, Bone Mineral Analyser, Concerning the Prediction of Improvement in Bone Status After an Infusion of Zoledronic Acid in Osteoporotic Women
A study testing Bone mineral analyser in people with Osteoporosis, run by University Hospital, Rouen.
Trial summary
Collection of epidemiological data Biological assessment as part of routine care. Measurement of the Hurst coefficient at D0 Measurement of bone density and TBS on D0 Zoledronic acid infusion the month following inclusion phone call at 1 month (observance of zoledronic acid) Measurement of bone density, calculation of… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Bone mineral analyser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women < 85 years old
- Postmenopausal women (amenorrhea for more than 12 months), a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).
- Post-menopausal osteoporosis with one or more severe fractures (upper end of the humerus, femur, or tibia; 3 adjacent ribs; lower end of the femur; thoracic or lumbar spine; pelvis), or T score <-3 which justifies setting up a bisphosphonate treatment
- Affiliated to social security
Who cannot join
- Contraindication to zoledronic acid (allergy to the product, creatinine clearance <35 ml / min, hypocalcemia, open and unhealed lesions of the soft tissues of the mouth)
- Hormone replacement therapy taken in the last 12 months
- Osteoprotective treatment (bisphosphonates, teriparatide, raloxifene, strontium ralenate or denosumab) taken in the last 12 months
- Secondary osteoporosis: hyperthyroidism, hyperparathyroidism, long-term corticosteroid therapy, hypercorticism, hypogonadism, treatment with anti aromatases / LHRH analogues, neoplastic pathology (solid or hemopathy)
- History of bilateral wrist or femur fracture
- Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship
- Patient participating in another trial / having participated in another trial within 6 months
About this study
- Collection of epidemiological data
- Biological assessment as part of routine care.
- Measurement of the Hurst coefficient at D0
- Measurement of bone density and TBS on D0
- Zoledronic acid infusion the month following inclusion
- phone call at 1 month (observance of zoledronic acid)
- Measurement of bone density, calculation of the Hurst coefficient at M12
- Conditions
- Osteoporosis
- Being tested
- Bone mineral analyser
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone mineral analyserDiagnostic test
high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12
| Study group | Role | What they receive |
|---|---|---|
| Bone mineral analyser | Experimental | Diagnostic Test: Bone mineral analyser
high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12 Receives: Diagnostic Test: Bone mineral analyser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hurst coefficient
measured by the BMA
Measured: Day 0
Secondary outcomes (5)
Hurst coefficient
measured by the BMA
Measured: Month 12
bone texture parameters
bone texture parameters measured by Trabecular Bone Score
Measured: Day 0
bone texture parameters
bone texture parameters measured by Trabecular Bone Score
Measured: Month 12
Bone mineral density
Bone mineral density measured by DXA scan
Measured: Day 0
Bone mineral density
Bone mineral density measured by DXA scan
Measured: Month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Why it stopped: Non-functional BMA machine.
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.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253340
- Sponsor's protocol ID
- 2017/183/HP
- Acronym
- TEOBASO
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2020
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Bone Assessment Technique, Bone Mineral Analyser, Concerning the Prediction of Improvement in Bone Status After an Infusion of Zoledronic Acid in Osteoporotic Women
- ClinicalTrials.gov ID
- NCT04253340
- Acronym / sponsor ID
- TEOBASO / 2017/183/HP
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Non-functional BMA machine.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 5 Feb 2020 (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.
- Collection of epidemiological data
- Biological assessment as part of routine care.
- Measurement of the Hurst coefficient at D0
- Measurement of bone density and TBS on D0
- Zoledronic acid infusion the month following inclusion
- phone call at 1 month (observance of zoledronic acid)
- Measurement of bone density, calculation of the Hurst coefficient at M12
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone mineral analyser | Experimental | Diagnostic Test: Bone mineral analyserDiagnostic Test: Bone mineral analyser high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women < 85 years old
- Postmenopausal women (amenorrhea for more than 12 months), a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).
- Post-menopausal osteoporosis with one or more severe fractures (upper end of the humerus, femur, or tibia; 3 adjacent ribs; lower end of the femur; thoracic or lumbar spine; pelvis), or T score <-3 which justifies setting up a bisphosphonate treatment
- Affiliated to social security
Key exclusion criteria (7 listed)
- Contraindication to zoledronic acid (allergy to the product, creatinine clearance <35 ml / min, hypocalcemia, open and unhealed lesions of the soft tissues of the mouth)
- Hormone replacement therapy taken in the last 12 months
- Osteoprotective treatment (bisphosphonates, teriparatide, raloxifene, strontium ralenate or denosumab) taken in the last 12 months
- Secondary osteoporosis: hyperthyroidism, hyperparathyroidism, long-term corticosteroid therapy, hypercorticism, hypogonadism, treatment with anti aromatases / LHRH analogues, neoplastic pathology (solid or hemopathy)
- History of bilateral wrist or femur fracture
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 |
|---|---|---|
| Bone mineral analyserhigh resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12 | Diagnostic test | Bone mineral analyser |
Primary outcome
Hurst coefficient
Time frame: Day 0
measured by the BMA
5 secondary outcomes
Hurst coefficient
Time frame: Month 12
bone texture parameters
Time frame: Day 0
bone texture parameters
Time frame: Month 12
Bone mineral density
Time frame: Day 0
Bone mineral density
Time frame: Month12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bone mineral analyser in people with Osteoporosis, run by University Hospital, Rouen.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 5 Jun 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hurst coefficient (time frame: Day 0). 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 5 Jun 2026.