A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases

Vertebral fracture is a common clinically significant skeletal related event in cancer patients. Stratification of patients diagnosed with one or more vertebral metastases according to the risk of pathological fracture is an unresolved problem despite the fact that fractures strongly influence the quality of life (QoL) and also the overall survival. The multidimensional nature and the strong patient specificity of the risk for fracture have not been considered in previously published risk estimation models and these methods were developed and validated only on retrospective data focusing on prevalence of life-time fracture which is not really relevant at the time of the diagnosis of a vertebral metastasis. To overcome these shortcomings, the METASTRA models (METASTRA-AI and METASTRA-VPH) and the decision support system (METASTRA-DSS) are developed considering the highest possible level of patient specificity to stratify the individuals according to their risk for fracture in a clinically considerable period (within next 6 months). The prospective data collection and analysis will provide reliability and validity results on the performance of METASTRA tools as well as structured information on user's experience helping the future integration of the developed patient-specific stratification tool into the everyday clinical practice.

The study is a prospective clinical data collection from minimum 200 patients to determine the validity (i.e. Precision) in fracture risk stratification of the METASTRA-AI and METASTRA-VPH computational models and to determine the reliability of METASTRA-AI and METASTRA-VPH as well as human decision making process in patient stratification.

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Key information

Conditions

Vertebral Metastases Back Injuries Fractures, Bone Neoplasms Spinal Fractures Spinal Injuries Vertebral Fracture Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurosurgery Charité Berlin, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient 18 years or older
Patient diagnosed with a metastatic tumor in the thoracic and/or lumbar spine (one or more vertebral metastases in the spinal region between T1 and L5 vertebrae)
Min. 1 vertebra is potentially unstable based on SINS score (SINS is 7-12) and it has not been surgically stabilized previously (level of interest - LOI)
Adjacent vertebrae are not surgically stabilized at the time of the enrollment
Patient willing to complete 6-month follow-up
Patient is willing and able to provide written informed consent after the nature of the study has been explained:

Ability to understand the content of the patient information/ ICF
Willingness and ability to participate in the study according to the protocol
Signed and dated EC approved written informed consent

Exclusion criteria

Poor general status at baseline (Karnofsky scale less than 40%)
Expected life expectancy is less than 3 months at baseline
Spinal infection
Ongoing litigation
Participation in investigational clinical study at the same time or within 3 months
Vertebral lesion/metastasis from a hematologic condition (e.g. multiple myeloma)

Treatment and study plan

Primary outcomes

new vertebral fracture

Time frame: in 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Aron Lazary, MD PhD

CONTACT

[email protected]

+36304847552

Julia Szita, PhD

CONTACT

[email protected]

+36205971605

Sponsors and collaborators

Lead sponsor

Buda Health Center

Other

Registry information

Acronym: Valid-METASTRA

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Apr 4, 2025
Registry last updated: Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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