Cortical Bone ErosionOCO-USNCT03453242
Age Influence on Cortical Bone Measured by Ultrasound
An observational study of Cortical Bone Erosion, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study of this study is to evaluate the age influence on cortical bone strength properties by two methods:HR-pQCT (HighResolution-peripheral quantitativeComputedTomography) and ultrasound. The main objective consists in the evaluation of the age influence on cortical thickness at 1/3 distal radius measured by US. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cortical Bone Erosion
- What is being tested?
- Bone measurement by HR-pQCT and ultrasound
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2018to 19 Jul 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort will be: Women and men less than 70 Women and men more than 70
Who may be able to join
- being 18 or older
- coming from the rheumatology consultation at Lariboisière Hospital
Who cannot join
- BMI > 28
- BMI < 15
- cortisone treatment
- recent fracture at non-dominant arm
- wound on measuring zone
- treatment interfering with bone architecture or bone density : oral of transdermic oestrogenes, bisphosphonates (Alendronate, Risedronate, Zoledronate) or Denosumab during the past 6 months-
Trial locations and contacts
1 site in 1 country.
About this study
The study of this study is to evaluate the age influence on cortical bone strength properties by two methods:HR-pQCT (HighResolution-peripheral quantitativeComputedTomography) and ultrasound. The main objective consists in the evaluation of the age influence on cortical thickness at 1/3 distal radius measured by US.
Read the detailed description
The study of this study is to evaluate the age influence on cortical bone by two methods: HR-pQCT and ultrasound.
84 patients will be measured. The cohort will be:
- 21 women less than 70
- 21 women more than 70
- 21 men less than 70
- 21 men more than 70 Measurement will be performed at radius and at tibia (ultra-distal and distal). For all the sites one measurement will be performed by HR-pQCT to get reference values of thickness and BMDs. For the distal positions and additional measurement will be performed by an innovative ultrasound device that estimates cortical thickness and porosity.
The participation to the study implies only a participation of one hour from the patient (30min for HR-pQCT measurements, 30 min for US).
The main objectives consist in :
- evaluating the age influence on cortical thickness at 1/3 distal radius measured by US
- evaluating the age influence on cortical thickness at distal tibia measured by US
- comparing porosities values measured by US to vBMD obtained by HR-pQCT
- comparing cortical thickness values measured by HR-pQCT at 1/3 distal radius position to ultra-distal radus position and to the tibia
- comparing vBMD values measured by HRpQCT at 1/3 distal radius position to ultra-distal radius position and to the tibia
- Conditions
- Cortical Bone Erosion
- Being tested
- Bone measurement by HR-pQCT and ultrasound
- Keywords
- Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone measurement by HR-pQCT and ultrasoundOther
Measurement will be performed at radius and at tibia (ultra-distal and distal). For all the sites one measurement will be performed by HR-pQCT to get reference values of thickness and BMDs. For the distal positions and additional measurement will be performed by an innovative ultrasound device that estimates cortical thickness and porosity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical parameters measurement
Cortical thickness at distal radius 1/3
Measured: Inclusion time
Secondary outcomes (7)
Tibia parameters measurement by US
Cortical thickness distal 1/2 tibia obtained by US
- ultra-distal and 1/3 distal cortical thicknesses obtained by HR-pQCT
- ultra-distal and 1/3 distal vBMD obtained by HR-pQCT
Measured: Inclusion time
Tibia parameters measurement by HR-pQCT
Cortical thickness distal 1/2 tibia obtained by HR-pQCT
- ultra-distal and 1/3 distal cortical thicknesses obtained by HR-pQCT
- ultra-distal and 1/3 distal vBMD obtained by HR-pQCT
Measured: Inclusion time
Porosity measurement
Ultrasonic porosity obtained by HR-pQCT
Measured: Inclusion time
vBMD measurement
vBMD obtained by HR-pQCT
Measured: Inclusion time
Cortical parameters measurement
1/3 distal cortical thicknesses obtained by HR-pQCT
Measured: Inclusion time
Thicknesses measurement
Ultra-distal thicknesses obtained by HR-pQCT
Measured: Inclusion time
Ultra-distal vBMD measurement
Ultra-distal vBMD and third distal obtained by HR-pQCT
Measured: Inclusion time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start2 Mar 2018
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Why it stopped: Difficulty of recruitment due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cortical Bone ErosionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cohen-Solal Martine, Martine, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453242
- Sponsor's protocol ID
- K 171006J
- Acronym
- OCO-US
- Status last verified
- Sep 2021
- First submitted
- 24 Jan 2018
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barkmann R, Kantorovich E, Singal C, Hans D, Genant HK, Heller M, Gluer CC. A new method for quantitative ultrasound measurements at multiple skeletal sites: first results of precision and fracture discrimination. J Clin Densitom. 2000 Spring;3(1):1-7. doi: 10.1385/jcd:3:1:001.
PubMed 10745297Bochud N, Vallet Q, Bala Y, Follet H, Minonzio JG, Laugier P. Genetic algorithms-based inversion of multimode guided waves for cortical bone characterization. Phys Med Biol. 2016 Oct 7;61(19):6953-6974. doi: 10.1088/0031-9155/61/19/6953. Epub 2016 Sep 12.
PubMed 27617648Zebaze RM, Ghasem-Zadeh A, Bohte A, Iuliano-Burns S, Mirams M, Price RI, Mackie EJ, Seeman E. Intracortical remodelling and porosity in the distal radius and post-mortem femurs of women: a cross-sectional study. Lancet. 2010 May 15;375(9727):1729-36. doi: 10.1016/S0140-6736(10)60320-0.
PubMed 20472174
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age Influence on Cortical Bone Measured by Ultrasound
- ClinicalTrials.gov ID
- NCT03453242
- Acronym / sponsor ID
- OCO-US / K 171006J
- Conditions
- Cortical Bone Erosion
- Keywords
- Osteoporosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty of recruitment due to COVID-19
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 5 Mar 2018 (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.
The study of this study is to evaluate the age influence on cortical bone strength properties by two methods:HR-pQCT (HighResolution-peripheral quantitativeComputedTomography) and ultrasound. The main objective consists in the evaluation of the age influence on cortical thickness at 1/3 distal radius measured by US.
Detailed description
The study of this study is to evaluate the age influence on cortical bone by two methods: HR-pQCT and ultrasound.
84 patients will be measured. The cohort will be:
- 21 women less than 70
- 21 women more than 70
- 21 men less than 70
- 21 men more than 70 Measurement will be performed at radius and at tibia (ultra-distal and distal). For all the sites one measurement will be performed by HR-pQCT to get reference values of thickness and BMDs. For the distal positions and additional measurement will be performed by an innovative ultrasound device that estimates cortical thickness and porosity.
The participation to the study implies only a participation of one hour from the patient (30min for HR-pQCT measurements, 30 min for US).
The main objectives consist in :
- evaluating the age influence on cortical thickness at 1/3 distal radius measured by US
- evaluating the age influence on cortical thickness at distal tibia measured by US
- comparing porosities values measured by US to vBMD obtained by HR-pQCT
- comparing cortical thickness values measured by HR-pQCT at 1/3 distal radius position to ultra-distal radus position and to the tibia
- comparing vBMD values measured by HRpQCT at 1/3 distal radius position to ultra-distal radius position and to the tibia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be: Women and men less than 70 Women and men more than 70
Key inclusion criteria (2 listed)
- being 18 or older
- coming from the rheumatology consultation at Lariboisière Hospital
Key exclusion criteria (6 listed)
- BMI > 28
- BMI < 15
- cortisone treatment
- recent fracture at non-dominant arm
- wound on measuring zone
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 measurement by HR-pQCT and ultrasoundMeasurement will be performed at radius and at tibia (ultra-distal and distal). For all the sites one measurement will be performed by HR-pQCT to get reference values of thickness and BMDs. For the distal positions and additional measurement will be performed by an innovative ultrasound device that estimates cortical thickness and porosity. | Other | – |
Primary outcome
Cortical parameters measurement
Time frame: Inclusion time
Cortical thickness at distal radius 1/3
7 secondary outcomes
Tibia parameters measurement by US
Time frame: Inclusion time
Tibia parameters measurement by HR-pQCT
Time frame: Inclusion time
Porosity measurement
Time frame: Inclusion time
vBMD measurement
Time frame: Inclusion time
Cortical parameters measurement
Time frame: Inclusion time
Thicknesses measurement
Time frame: Inclusion time
Ultra-distal vBMD measurement
Time frame: Inclusion time
Results and safety
The study was stopped early (reason given: Difficulty of recruitment due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 10745297Barkmann R, Kantorovich E, Singal C, Hans D, Genant HK, Heller M, Gluer CC. A new method for quantitative ultrasound measurements at multiple skeletal sites: first results of precision and fracture discrimination. J Clin Densitom. 2000 Spring;3(1):1-7. doi: 10.1385/jcd:3:1:001.
- Background: PubMed 27617648Bochud N, Vallet Q, Bala Y, Follet H, Minonzio JG, Laugier P. Genetic algorithms-based inversion of multimode guided waves for cortical bone characterization. Phys Med Biol. 2016 Oct 7;61(19):6953-6974. doi: 10.1088/0031-9155/61/19/6953. Epub 2016 Sep 12.
- Background: PubMed 20472174Zebaze RM, Ghasem-Zadeh A, Bohte A, Iuliano-Burns S, Mirams M, Price RI, Mackie EJ, Seeman E. Intracortical remodelling and porosity in the distal radius and post-mortem femurs of women: a cross-sectional study. Lancet. 2010 May 15;375(9727):1729-36. doi: 10.1016/S0140-6736(10)60320-0.
- Individual participant dataSharing planned: Undecided
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.
Cohen-Solal Martine, Martine principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cortical Bone Erosion, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Difficulty of recruitment due to COVID-19). Results are not available in the source record.
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?
Cortical parameters measurement (time frame: Inclusion time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453242, which also lists 3 linked publications.
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 27 Sep 2021.