BONDIR: Bonviva IV in the treatment of pain associated with recent osteoporotic vertebral fractures. A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy of intravenous ibandronate on pain associated with a recent osteoporotic vertebral fracture - BONDIR

INTERVENTION: Trade Name: BONVIVA Product Code: RO 200-5450/V27 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ibandronic Acid Current Sponsor code: RO 200-5450 Concentration unit: mg/ml milligram(s)/milliliter Concentration type: equal Concentration number: 3 mg/3 ml Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: Patient suffering from a recent osteoporotic vertebral fracture. ; MedDRA version: 9.1 Level: LLT Classification code 10031290 Term: Osteoporotic fracture ; MedDRA version: 9.1 Level: LLT Classification code 10013601 Term: Dorsal pain PRIMARY OUTCOME: Main Objective: Evaluation of the efficacy of IV ibandronate on pain associated with a recent osteoporotic vertebral fracture. Primary endpoint(s): EFFICACY (Primary Endpoint): On day 7, the percentage of success with IV ibandronate treatment. Success is defined by the combination of the following 3 criteria: 1) A 20% reduction in pain intensity on day 7 compared to baseline (day 0), measured using a 100 mm VAS, in a seated position or during mobilization if sitting is impossible, in the morning between 8:00 and 10:00 AM. 2) With stabilization or reduction of the concomitant analgesic dosage between days 3 and 7. 3) Without an increase in the concomitant analgesic dosage between days 3 and 7. TOLERANCE: - Incidence of serious adverse events; - Incidence of all adverse events. Secondary Objective: Pain control, measurement of healthcare utilization, length of hospital stay; tolerability. INCLUSION CRITERIA: - Postmenopausal women or men over 50 years of age; - Having provided written consent to participate; - Able, according to the investigator, to complete the questionnaires and comply with the study requirements; - Patients affiliated with or beneficiaries of a social security scheme; - Having a vertebral fracture estimated by the investigator to be of osteoporotic origin: confirmed by spinal X-ray or magnetic resonance imaging (MRI) or computed tomography (CT); - Having a vertebral fracture less than 4 weeks old and whose recent nature has been confirmed by spinal X-ray or magnetic resonance imaging (MRI) or computed tomography (CT) or scintigraphy; - Suffering from fracture-related pain: Reaching a level > 40 mm on a 100 mm visual analog scale (VAS), during an assessment in a seated position or during mobilization if necessary.