Bone MetastasesNCT06524843
Fracture Risk Evaluation of Bone Metastases Derived From Carcinoma
An observational study of Bone Metastases, run by Costantino Errani at 1 site in Italy.
Trial summary
From the archives of the Rizzoli institute all patients (approximately 750) treated for bone metastases from 01/01/2010 to 31/12/2022. A review will be made from the medical records, radiological imaging, and histological data of these patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Analysis
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 23 Sep 2024to Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Male and female adult patients, affected by bone metastases derived from carcinoma, treated at Rizzoli Ortopaedic institute from 01/01/2010 to 31/12/2022.
Who may be able to join
- Age ≥ 18 years
- Diagnosis of bone metastasis from carcinoma, regardless of the type of carcinoma, and of the number and location of the metastases
- Availability of imaging and clinical data
- Availability of at least one follow-up during the last 12 months form diagnosis
Who cannot join
- At least one inclusion creteria not met
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, 40134
Costantino Errani, MD, 0516366 ext. 103, costantino.errani@ior.it
Roberta Laranga, PhD, 051636 ext. 5123, roberta.laranga@ior.it
About this study
Official title: Generation of Synthetic Patient Data (RAW) for Risk Evaluation of Bone Metastases Derived From Carcinoma
From the archives of the Rizzoli institute all patients (approximately 750) treated for bone metastases from 01/01/2010 to 31/12/2022.
A review will be made from the medical records, radiological imaging, and histological data of these patients
- Conditions
- Bone Metastases
- Being tested
- Analysis
- Keywords
- Bone metastases, Prediction model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnalysisOther
Analysis and review of imaging and clinical data
| Study group | Role | What they receive |
|---|---|---|
| Patients | Male and female patients affected by bone metastases derived from carcinoma, treated at Rizzoli Orthopaedic Institute from 01/01/2010 to 31/12/2022 Receives: Other: Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation a dataset of clinical data and diagnostic images
Creation a dataset of clinical data and diagnostic images, called RAW, relating to patients suffering from metastatic bone cancer that will be used by the unit UNICH to create innovative models for fracture risk prediction and of life expectancy based on various patient clinical parameters.
Measured: At baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start23 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Costantino Errani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Costantino Errani, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524843
- Sponsor's protocol ID
- FRAIL-RAW
- Status last verified
- Dec 2025
- First submitted
- 23 Jul 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mirels H. Metastatic disease in long bones: A proposed scoring system for diagnosing impending pathologic fractures. 1989. Clin Orthop Relat Res. 2003 Oct;(415 Suppl):S4-13. doi: 10.1097/01.blo.0000093045.56370.dd.
PubMed 14600587Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6243s-6249s. doi: 10.1158/1078-0432.CCR-06-0931.
PubMed 17062708
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Synthetic Patient Data (RAW) for Risk Evaluation of Bone Metastases Derived From Carcinoma
- ClinicalTrials.gov ID
- NCT06524843
- Acronym / sponsor ID
- FRAIL-RAW
- Conditions
- Bone Metastases
- Keywords
- Bone metastases, Prediction model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Costantino ErraniUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 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.
From the archives of the Rizzoli institute all patients (approximately 750) treated for bone metastases from 01/01/2010 to 31/12/2022.
A review will be made from the medical records, radiological imaging, and histological data of these patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: AnalysisMale and female patients affected by bone metastases derived from carcinoma, treated at Rizzoli Orthopaedic Institute from 01/01/2010 to 31/12/2022 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female adult patients, affected by bone metastases derived from carcinoma, treated at Rizzoli Ortopaedic institute from 01/01/2010 to 31/12/2022.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of bone metastasis from carcinoma, regardless of the type of carcinoma, and of the number and location of the metastases
- Availability of imaging and clinical data
- Availability of at least one follow-up during the last 12 months form diagnosis
Key exclusion criteria (1 listed)
- At least one inclusion creteria not met
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 |
|---|---|---|
| AnalysisAnalysis and review of imaging and clinical data | Other | Patients |
Primary outcome
Creation a dataset of clinical data and diagnostic images
Time frame: At baseline (Day 0)
Creation a dataset of clinical data and diagnostic images, called RAW, relating to patients suffering from metastatic bone cancer that will be used by the unit UNICH to create innovative models for fracture risk prediction and of life expectancy based on various patient clinical parameters.
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 15 Dec 2025.
- Background: PubMed 14600587Mirels H. Metastatic disease in long bones: A proposed scoring system for diagnosing impending pathologic fractures. 1989. Clin Orthop Relat Res. 2003 Oct;(415 Suppl):S4-13. doi: 10.1097/01.blo.0000093045.56370.dd.
- Background: PubMed 17062708Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6243s-6249s. doi: 10.1158/1078-0432.CCR-06-0931.
- Individual participant dataSharing planned: Undecided
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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.
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 Bone Metastases, run by Costantino Errani 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 15 Dec 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 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 Costantino Errani, MD (0516366 ext. 103, costantino.errani@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation a dataset of clinical data and diagnostic images (time frame: At baseline (Day 0)). 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 NCT06524843, which also lists 2 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 15 Dec 2025.