Wounds and Injuries

All Conditions

Neoplasms

Symptoms and General Pathology

Fractures, Bone

Neoplasm Metastasis

Neoplastic Processes

Patients affected by spinal metastases that are not surgically treated

Extraction of clinical and radiographic data related to patients' history from medical records

Case series review of clinical and radiographic data

Giovanni Barbanti Brodano, MD

Cristiana Griffoni, PhD

Peter Vajkoczy

Aron Lazary

Jorrit-Jan Verlaan

Train-METASTRA is a retrospective study that will be performed in order to collect a large and harmonised amount of clinical and imaging data concerning vertebral metastases, focusing in particular on the risk of fractures. This type of dataset will be created from the medical records of 2000 patients admitted in the last ten years in the four European clinical centers participating in METASTRA project: "COMPUTER-AIDED EFFECTIVE FRACTURE RISK STRATIFICATION OF PATIENTS WITH VERTEBRAL METASTASES FOR PERSONALISED TREATMENT THROUGH ROBUST COMPUTATIONAL MODELS VALIDATED IN CLINICAL SETTINGS", funded by the European Union under the call "HORIZON-HLTH-2022-TOOL-12-two-stage/Computational models for new patient stratification strategies". The project is coordinated by the University of Bologna (UNIBO) (PI prof. Luca Cristofolini) and involves 15 European partners, including Sarl Voisin Consulting Life Sciences VCLS, University of Szeged (Hungary), University of Sheffield (UK) and FrontEndART (Hungary).

This type of dataset is not currently available in the literature and it will be pivotal to the development of the METASTRA computational models for the stratification of the risk of fracture of patients affected by spinal metastases.

Multicentric European Study In Patients With Vertebral Metastases

Retrospective Multicentric European Study In Patients With Vertebral Metastases (Train-Metastra)

The primary objective of the study is to identify the main relevant characteristics to be used for stratifying the patients with vertebral metastases based on their risk of fracture.

The primary objective of the study is to identify the main relevant demographic, clinical and radiographic characteristics to be used for stratifying the patients with vertebral metastases based on their risk of fracture.

To train the data-driven computational models (METASTRA-AI) developed within the project

To inform the physiology-based biomechanical models (METASTRA-VPH) developed within the project

Istituto Ortopedico Rizzoli

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Breast Neoplasms

Osteoporosis

Fractures, Open

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Bone Density Conservation Agents

Channel Blockers

Hormones

Anastrozole

Diphosphonates

Risedronic Acid

Antineoplastic Agents, Hormonal

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Calcium

Calcium Channel Blockers

Calcium, Dietary

High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum

Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum

Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum

Risedronate Sodium

AstraZeneca Arimidex Medical Science Director, MD

The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.

Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer

A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated

AstraZeneca

Francisco Sapunar, MD - Arimidex Medical Science Director

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Multicentric European Study In Patients With Vertebral Metastases	NCT06220071	Spinal Metastas...	Case series rev...	18 Years -	Istituto Ortopedico Rizzoli
Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer	NCT00082277	Breast Cancer	Anastrozole Risedronate Sod...	55 Years -	AstraZeneca

Spots Global Cancer Trial Database for risk of fracture