protocolSection identificationModule nctId: NCT06263517, orgStudyIdInfo id: SPA-S-899-01-21, secondaryIdInfos id: 2021-003124-33, type: EUDRACT_NUMBER, briefTitle: Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-12, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: SPA Società Prodotti Antibiotici S.p.A., class: INDUSTRY, collaborators name: Pharmaceutical Development and Services, descriptionModule briefSummary: The goal of this clinical trial is to to clarify which is the best dose of administration, to select a dose and to confirm the therapeutic efficacy of clodronate in patients with painful knee osteoarthritis (OA). The clinical trial will be divided in two parts.The main questions it aims to answer are:* in Phase II, to assess the safety and tolerability of different escalating doses of intra articular (IA) clodronate* in Phase II, to set a defined therapeutic dose (DTD) to be used in Phase III* in Phase III, to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA, conditionsModule conditions: Osteoarthritis of Knee, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Adaptative, multicenter, randomized, double-blind, parallel-group, placebo controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Randomization list will be performed with Proc Plan procedure by SAS ® Software (release 9.4 or later) software using the block randomization method with block size of 4.Subjects eligible at Baseline will be randomly allocated to receive 2, 5, 10 /2ml or placebo according to the balanced randomization list., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 296, type: ESTIMATED, armsInterventionsModule interventions name: Clodronate, interventions name: Clodronate, interventions name: Clodronate, interventions name: Placebo, outcomesModule primaryOutcomes measure: Efficacy: VAS Reduction, secondaryOutcomes measure: VAS mean changes, secondaryOutcomes measure: VAS mean changes observed 120 minutes after IA, secondaryOutcomes measure: Lequesne Algofunctional Index mean changes, secondaryOutcomes measure: WOMAC mean changes, secondaryOutcomes measure: Range of motion mean changes, secondaryOutcomes measure: Paracetamol consumption, otherOutcomes measure: SAE Reporting, otherOutcomes measure: AE Reporting, otherOutcomes measure: Clinical signs of intolerance Recording, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituti Clinici Maugeri, status: RECRUITING, city: Castel Goffredo, state: Mantova, zip: 46042, country: Italy, contacts name: Lul Abdi-Ali, role: CONTACT, geoPoint lat: 45.29403, lon: 10.473, locations facility: Ospedale San Pellegrino, status: RECRUITING, city: Castiglione delle Stiviere, state: Mantova, zip: 46043, country: Italy, contacts name: Paolo Roberto Ferrari, role: CONTACT, geoPoint lat: 45.3902, lon: 10.48619, locations facility: Ospedale Civile Servizio di Riabilitazione Funzionale, status: RECRUITING, city: Volta Mantovana, state: Mantova, zip: 46049, country: Italy, contacts name: Luisa Selletti, role: CONTACT, geoPoint lat: 45.32192, lon: 10.65891, locations facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga, status: NOT_YET_RECRUITING, city: Orbassano, state: Torino, zip: 10043, country: Italy, contacts name: Filippo Castoldi, role: CONTACT, geoPoint lat: 45.00547, lon: 7.53813, locations facility: Centro Riabilitativo Polifunzionale Teresio Borsalino, status: RECRUITING, city: Alessandria, zip: 15122, country: Italy, contacts name: Marco Invernizzi, role: CONTACT, geoPoint lat: 44.90924, lon: 8.61007, locations facility: IRCCS Ospedale Policlinico San Martino, status: RECRUITING, city: Genova, zip: 16132, country: Italy, contacts name: Matteo Formica, role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Ospedale Israelitico, status: RECRUITING, city: Roma, zip: 00148, country: Italy, contacts name: Maria Chiara Meloni, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Pietro, status: RECRUITING, city: Rome, zip: 00189, country: Italy, contacts name: Alberto Migliore, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Paolo, status: NOT_YET_RECRUITING, city: Savona, zip: 17100, country: Italy, contacts name: Danilo Chiapale, role: CONTACT, geoPoint lat: 44.30905, lon: 8.47715, locations facility: Azienda Ospedaliero Universitaria Senese, status: RECRUITING, city: Siena, zip: 53100, country: Italy, contacts name: Bruno Frediani, role: CONTACT, geoPoint lat: 43.31822, lon: 11.33064, locations facility: Ospedale Policlinico "G.B. Rossi" Borgo Roma, status: RECRUITING, city: Verona, zip: 37134, country: Italy, contacts name: Luca Dalle Carbonare, role: CONTACT, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False