Wounds and Injuries

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Fractures, Bone

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Pharmaceutical Solutions

All Drugs and Chemicals

Bone Density Conservation Agents

Zoledronic Acid

Patients receive RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction. combined with zoledronic acid (4 mg IV slow monthly for 12 months, dose adjusted according to creatinine clearance).

Patients receive only RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction.

All patients receive radiotherapy i.e. treatment on D1, D3 and D5.

Several radiotherapy schemes are possible:

* 20 Gy in 1 fraction;
* 27 Gy in 3 fractions of 9 Gy
* 30 Gy in 5 fractions of 6 Gy. All patients in the experimental arm receive an intravenous injection of at least 15 minutes of 4 mg zoledronic acid every month for 12 months.

The first injection must be made no more than 3 weeks before the first day of radiotherapy. It can be performed up to J1 of radiotherapy.

The injections will be carried out either at the patient's home by the nurses or in the investigator centre.

Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions

All patients receive radiotherapy i.e. treatment on D1, D3 and D5.

Several radiotherapy schemes are possible:

* 20 Gy in 1 fraction;
* 27 Gy in 3 fractions of 9 Gy
* 30 Gy in 5 fractions of 6 Gy.

Hypo-fractured radiotherapy in stereotactic conditions

Stéphane SUPIOT, MD

Stéphanie BATARD, MD

JEAN-CHRISTOPHE FAIVRE, MD

Jean-Christophe FAIVRE, MD

Xavier BUTHAUD, MD

René-Jean BENSADOUN, MD

Ariane LAPIERRE, MD

SEBASTIEN THUREAU, MD

Sébastien THUREAU, MD

Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease.

Zoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.

Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases

Phase III Randomized, Controlled, Open, Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases

The determination of the DCRR includes Identification of care consumption ; The measurement of costs ; overall survival at 2 years ; Calculation of utilities using the EQ5D-5L questionnaire

Pain control will be assessed using a visual analogue scale (VAS) that measures pain intensity, prevents it, initiates or monitors drug or non-drug treatment, and the Brief Pain inventory, a questionnaire that quickly assesses the severity of pain and its impact on the patient's daily life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases	NCT03951493	Vertebral Metas...	Zoledronic Acid... Hypo-fractured ...	18 Years -	Institut Cancerologie de l'Ouest
Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases	NCT03951493	Vertebral Metas...	Zoledronic Acid... Hypo-fractured ...	18 Years -	Institut Cancerologie de l'Ouest

Spots Global Cancer Trial Database for vertebral compressive fracture