Cystic FibrosisMUCO-OSNCT03492567
Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors.
A study testing Blood test in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to look for risk factors of developing osteoporosis in patients with cystic fibrosis. Blood cells called monocytes will be obtained from a blood sample. These monocytes will make possible to form another class of cells called osteoclasts in the laboratory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2018to 4 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with cystic fibrosis
- attending the Paris Cochin adult CF centre
- with at least F508del mutation (homozygote or heterozygote patients)
Who cannot join
- patients younger than 18
- absence of signed consent
- patients without a F508del mutation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.
The aim of the study is to look for risk factors of developing osteoporosis in patients with cystic fibrosis.
Blood cells called monocytes will be obtained from a blood sample. These monocytes will make possible to form another class of cells called osteoclasts in the laboratory. These latter cells are responsible for bone degradation and therefore promote the increase of bone fragility. The research will focus on the characterization of these cells to better understand their potential (low, medium or high) to increase bone fragility in patients with cystic fibrosis.
Finally the action of CFTR modulators on these bone cells will be tested.
Read the detailed description
The aim of the study is to characterize the profile of circulating monocytes as predictive biomarker of osteoclastogenesis in CF related bone disease.
Investigators will evaluate the presence and regulation of CD115 (MCSF receptor) and CD265 (RANK) membrane receptors of circulating monocytes of cystic fibrosis patients.
They will also analyze the impact of the F508del CFTR mutation on the differentiation of monocytes into osteoclasts. We will 1) Quantify the training and functional activity of osteoclasts and, 2) Test in vitro the effects of correctors and potentiators of CFTR on the resorption activity of differentiated osteoclasts.
The study will be explained to patients and they only will have one blood test.
- Conditions
- Cystic Fibrosis
- Being tested
- Blood test
- Keywords
- Cystic fibrosis, CFTR, CFTR modulators, Monocyte, Osteoclast, Osteoporosis
- Medical subject headings
- Cystic Fibrosis, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
Blood draw (max 15 ml)
| Study group | Role | What they receive |
|---|---|---|
| Blood monocyte precursors/osteoclasts | Experimental | Blood test Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotype of CD14 monocytes/osteoclasts
Measured: 1 day
Secondary outcomes (1)
In vitro test of CFTR modulators
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start25 Apr 2018
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Dominique HUBERT, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492567
- Sponsor's protocol ID
- K171004J
- Other IDs
- 2017-A02965-48
- Acronym
- MUCO-OS
- Status last verified
- Nov 2025
- First submitted
- 3 Apr 2018
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jourdain ML, Sergheraert J, Braux J, Guillaume C, Gangloff SC, Hubert D, Velard F, Jacquot J. Osteoclastogenesis and sphingosine-1-phosphate secretion from human osteoclast precursor monocytes are modulated by the cystic fibrosis transmembrane conductance regulator. Biochim Biophys Acta Mol Basis Dis. 2021 Mar 1;1867(3):166010. doi: 10.1016/j.bbadis.2020.166010. Epub 2020 Nov 11.
PubMed 33188942
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.
- ClinicalTrials.gov ID
- NCT03492567
- Acronym / sponsor ID
- MUCO-OS / K171004J
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, CFTR, CFTR modulators, Monocyte, Osteoclast, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, URC-CIC Paris Descartes Necker Cochin
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 10 Apr 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 aim of the study is to look for risk factors of developing osteoporosis in patients with cystic fibrosis.
Blood cells called monocytes will be obtained from a blood sample. These monocytes will make possible to form another class of cells called osteoclasts in the laboratory. These latter cells are responsible for bone degradation and therefore promote the increase of bone fragility. The research will focus on the characterization of these cells to better understand their potential (low, medium or high) to increase bone fragility in patients with cystic fibrosis.
Finally the action of CFTR modulators on these bone cells will be tested.
Detailed description
The aim of the study is to characterize the profile of circulating monocytes as predictive biomarker of osteoclastogenesis in CF related bone disease.
Investigators will evaluate the presence and regulation of CD115 (MCSF receptor) and CD265 (RANK) membrane receptors of circulating monocytes of cystic fibrosis patients.
They will also analyze the impact of the F508del CFTR mutation on the differentiation of monocytes into osteoclasts. We will 1) Quantify the training and functional activity of osteoclasts and, 2) Test in vitro the effects of correctors and potentiators of CFTR on the resorption activity of differentiated osteoclasts.
The study will be explained to patients and they only will have one blood test.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood monocyte precursors/osteoclasts | Experimental | Biological: Blood testBlood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with cystic fibrosis
- attending the Paris Cochin adult CF centre
- with at least F508del mutation (homozygote or heterozygote patients)
Key exclusion criteria (3 listed)
- patients younger than 18
- absence of signed consent
- patients without a F508del mutation
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 |
|---|---|---|
| Blood testBlood draw (max 15 ml) | Biological | Blood monocyte precursors/osteoclasts |
Primary outcome
Phenotype of CD14 monocytes/osteoclasts
Time frame: 1 day
1 secondary outcome
In vitro test of CFTR modulators
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 33188942Jourdain ML, Sergheraert J, Braux J, Guillaume C, Gangloff SC, Hubert D, Velard F, Jacquot J. Osteoclastogenesis and sphingosine-1-phosphate secretion from human osteoclast precursor monocytes are modulated by the cystic fibrosis transmembrane conductance regulator. Biochim Biophys Acta Mol Basis Dis. 2021 Mar 1;1867(3):166010. doi: 10.1016/j.bbadis.2020.166010. Epub 2020 Nov 11.
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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.
Dominique HUBERT, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Cystic Fibrosis, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Nov 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phenotype of CD14 monocytes/osteoclasts (time frame: 1 day). 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 NCT03492567, which also lists 1 linked publication.
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 20 Nov 2025.