Neoplasm MetastasisBMDNCT03416959
Bone Metastases Database of Patients Treated Surgically for Impending or Pathologic Fracture of Long Bones
An observational study of Neoplasm Metastasis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs), Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- intramedullary fixation or endoprosthetic reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 31 Dec 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with bone metastases in the extremities treated with intramedullary fixation or endoprosthetic recosntruction for impending fracture or pathologic fracture
Who may be able to join
- Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction
Who cannot join
- Patients with bone metastases of the spine
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
Istituto Ortopedico Rizzoli
Bologna, Bologna, 40136
Costantino Errani, MD, PhD, 0039 051 6366103, costantino.errani@ior.it
Davide Donati, MD, 0039 051 6366012, davidemaria.donati@ior.it
About this study
Official title: Prospective Bone Metastases Database
The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),
Read the detailed description
The aims of this study are to evaluate clinical and biological factors of patients with BMs after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.
- Conditions
- Neoplasm Metastasis
- Being tested
- intramedullary fixation or endoprosthetic reconstruction
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramedullary fixation or endoprosthetic reconstructionProcedure or surgery
Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction
The study includes the collection of clinical data (age, sex, Karnofsky score) and laboratory data related to the patient (erythrocyte sedimentation rate, C reactive protein, Alkaline phosphatase, white blood cells and hemoglobin) at the time of admission, data on the pathology (histotype, site of bone metastasis , presence of further skeletal or visceral metastases), type of surgery performed (stabilization versus resection).The objectives of this study is to examine clinical outcomes after after surgical treatment of bone metastases with a specific focus on differences in complication rate between patients treated with intramedullary nail versus endoprosthetic reconstruction
Measured: 24 months
Secondary outcomes (1)
Survival in patients undergoing surgery for metastatic bone disease
Provide a reliable and objective means of estimating survival in patients with metastatic bone disease based on disease-specific and laboratory tests
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Costantino Errani, Istituto Ortopedico Rizzoli
- Investigators
- Costantino Errani, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416959
- Sponsor's protocol ID
- 0012807
- Acronym
- BMD
- Status last verified
- Jul 2025
- First submitted
- 11 Jan 2018
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be published in the international literature at the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Bone Metastases Database
- ClinicalTrials.gov ID
- NCT03416959
- Acronym / sponsor ID
- BMD / 0012807
- Conditions
- Neoplasm Metastasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Jan 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 aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),
Detailed description
The aims of this study are to evaluate clinical and biological factors of patients with BMs after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with bone metastases in the extremities treated with intramedullary fixation or endoprosthetic recosntruction for impending fracture or pathologic fracture
Key inclusion criteria (1 listed)
- Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction
Key exclusion criteria (1 listed)
- Patients with bone metastases of the spine
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 |
|---|---|---|
| intramedullary fixation or endoprosthetic reconstructionSurgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction | Procedure or surgery | – |
Primary outcome
Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction
Time frame: 24 months
The study includes the collection of clinical data (age, sex, Karnofsky score) and laboratory data related to the patient (erythrocyte sedimentation rate, C reactive protein, Alkaline phosphatase, white blood cells and hemoglobin) at the time of admission, data on the pathology (histotype, site of bone metastasis , presence of further skeletal or visceral metastases), type of surgery performed (stabilization versus resection).The objectives of this study is to examine clinical outcomes after after surgical treatment of bone metastases with a specific focus on differences in complication rate between patients treated with intramedullary nail versus endoprosthetic reconstruction
1 secondary outcome
Survival in patients undergoing surgery for metastatic bone disease
Time frame: 24 months
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 1 Aug 2025.
- Individual participant dataSharing planned: No. The data will be published in the international literature at the end of the study
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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.
Costantino Errani, MD principal investigator
Istituto Ortopedico Rizzoli
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 Neoplasm Metastasis, run by Istituto Ortopedico Rizzoli 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 1 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 1 Aug 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 (+390516366103, costantino.errani@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction (time frame: 24 months). 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 1 Aug 2025.