Osteogenesis ImperfectaNCT07412782
REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD)
A study testing REMS in people with Osteogenesis Imperfecta and Osteoporosis, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial summary
This study evaluates bone mineral density (BMD) in pediatric patients aged 5-18 years with conditions negatively affecting bone health, using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free ultrasound technology. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Osteogenesis Imperfecta, Osteoporosis, Hypogonadisms
- What is being tested?
- REMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent from adult patients or parents/legal guardians
- Age between 5 and 18 years
- Both sexes and all ethnicities
- Known condition negatively affecting bone health
Who cannot join
- Age below 5 years or over 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Observational Study for the Assessment of Bone Mineral Density (BMD) Using REMS Technology
This study evaluates bone mineral density (BMD) in pediatric patients aged 5-18 years with conditions negatively affecting bone health, using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free ultrasound technology. Bone health is crucial during childhood, when peak bone mass develops, and reduced BMD is associated with increased fracture risk. DXA is the current reference method but has limitations in children, including radiation exposure and growth-related measurement issues. REMS has been validated in adults and shows promise in pediatrics, despite the lack of reference values. The study is a single-center, national, non-profit interventional study lasting about 12 months. Participants will undergo REMS BMD measurement, clinical history collection, and assessment of anthropometric and pubertal parameters, with prior DXA data collected when available. The primary aim is to describe BMD values measured by REMS in pediatric osteoporosis, with secondary aims including subgroup analyses and comparison with DXA. A sample of 100 patients is planned. Statistical analyses will assess BMD distributions, correlations with clinical variables, and agreement between REMS and DXA using correlation coefficients and Bland-Altman analysis.
- Conditions
- Osteogenesis Imperfecta, Osteoporosis, Hypogonadisms, Neoplasia, Obesity & Overweight, Malnutrition (Calorie)
- Being tested
- REMS
- Medical subject headings
- Osteogenesis Imperfecta, Osteoporosis, Neoplasms, Obesity, Overweight, Malnutrition, Cushing Syndrome, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMSDiagnostic test
REMS (Radiofrequency Echographic Multi Spectrometry) technology, a non-invasive, radiation-free ultrasound system to detect BMD. REMS has obtained FDA and CE approval and has been validated
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Test | Experimental | Not described Receives: Diagnostic Test: REMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD values in primary osteoporosis
Mean and median of Bone Mineral Density values obtained in the pediatric population affected by primary osteoporosis
Measured: At the enrollement
Secondary outcomes (1)
BMD values in pediatric patients with conditions negatively affecting bone health
Mean and median of Bone Mineral Density values in pediatric patients with conditions negatively affecting bone health
Measured: At the enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start4 Dec 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Stagi, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412782
- Sponsor's protocol ID
- REMS25
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for the Assessment of Bone Mineral Density (BMD) Using REMS Technology
- ClinicalTrials.gov ID
- NCT07412782
- Acronym / sponsor ID
- REMS25
- Conditions
- Osteogenesis Imperfecta, Osteoporosis, Hypogonadisms, Neoplasia, Obesity & Overweight, Malnutrition (Calorie)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (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.
This study evaluates bone mineral density (BMD) in pediatric patients aged 5-18 years with conditions negatively affecting bone health, using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free ultrasound technology. Bone health is crucial during childhood, when peak bone mass develops, and reduced BMD is associated with increased fracture risk. DXA is the current reference method but has limitations in children, including radiation exposure and growth-related measurement issues. REMS has been validated in adults and shows promise in pediatrics, despite the lack of reference values. The study is a single-center, national, non-profit interventional study lasting about 12 months. Participants will undergo REMS BMD measurement, clinical history collection, and assessment of anthropometric and pubertal parameters, with prior DXA data collected when available. The primary aim is to describe BMD values measured by REMS in pediatric osteoporosis, with secondary aims including subgroup analyses and comparison with DXA. A sample of 100 patients is planned. Statistical analyses will assess BMD distributions, correlations with clinical variables, and agreement between REMS and DXA using correlation coefficients and Bland-Altman analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test | Experimental | Diagnostic Test: REMS |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Written informed consent from adult patients or parents/legal guardians
- Age between 5 and 18 years
- Both sexes and all ethnicities
- Known condition negatively affecting bone health
Key exclusion criteria (1 listed)
- Age below 5 years or over 18 years
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 |
|---|---|---|
| REMSREMS (Radiofrequency Echographic Multi Spectrometry) technology, a non-invasive, radiation-free ultrasound system to detect BMD. REMS has obtained FDA and CE approval and has been validated | Diagnostic test | Diagnostic Test |
Primary outcome
BMD values in primary osteoporosis
Time frame: At the enrollement
Mean and median of Bone Mineral Density values obtained in the pediatric population affected by primary osteoporosis
1 secondary outcome
BMD values in pediatric patients with conditions negatively affecting bone health
Time frame: At the enrollement
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 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Osteogenesis Imperfecta
Active, not recruitingPhase 2/3
Setrusumab vs Placebo for Osteogenesis Imperfecta
Osteogenesis Imperfecta
Active, not recruitingPhase 3
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
Osteogenesis Imperfecta
RecruitingPhase 2
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
Osteogenesis Imperfecta (OI)
Active, not recruitingPhase 3
Setrusumab in Pediatric Japanese Subjects With Osteogenesis Imperfecta
Osteogenesis Imperfecta
RecruitingPhase 2
A Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR)
Osteogenesis Imperfecta (OI)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMS in people with Osteogenesis Imperfecta and Osteoporosis, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
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 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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 Italy. 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?
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 Stefano Stagi, Professor (0039 0555662305, stefano.stagi@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMD values in primary osteoporosis (time frame: At the enrollement). 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 17 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.