NCT06263517

Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients

Adaptative, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled, Clinical Trial, on the Efficacy and Tolerability of Different Escalating Doses of Intra-articular Clodronate in Patients With Painful Knee Osteoarthritis

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 296 (estimated)
• Sponsor: SPA Società Prodotti Antibiotici S.p.A. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The phase II will be a multicenter, double-blind, randomized, placebo-controlled, parallel group four-arm study, according to the treatment dose (dose finding). Briefly, 4 groups of 74 patients (in order to have 64 fully evaluated patients taking into consideration 10 patients dropped out), i.e. a total of 296 patients, with knee OA each will be randomly allocated to the following treatments: 1. IA clodronate 2 mg/2 ml once a week for 4 weeks (total clodronate dose = 8 mg). 2. IA clodronate 5 mg/2 ml once a week for 4 weeks (total clodronate dose = 20 mg). 3. IA clodronate 10 mg/2 ml once a week for 4 weeks (total clodronate dose = 40 mg). 4. Placebo 2 ml once a week for 4 weeks (total clodronate dose = 0 mg). At the end of phase II, the minimum effective clodronate dose will be selected as DTD for the Phase III. The phase III will be a multicenter, double-blind, randomized, placebo-controlled, two parallel groups (DTD vs. placebo) study. Briefly, patients with knee OA will be randomly assigned to two experimental groups: 1. the DTD defined during the Phase II. 2. Matching placebo. The sample size of Phase III will be definitively calculated according to the extent of pain Visual Analogue Scale (VAS) reduction observed in the Phase II.

Conditions

• Osteoarthritis of Knee

Interventions

Type	Name	Description
DRUG	Clodronate	For Arm 1, patients will be treated with intra articular clodronate 2 mg/2 ml from Baseline to Week 3
DRUG	Clodronate	For Arm 2, patients will be treated with intra articular clodronate 5 mg/2 ml from Baseline to Week 3
DRUG	Clodronate	For Arm 3, patients will be treated with intra articular clodronate 10 mg/2 ml from Baseline to Week 3
DRUG	Placebo	For Arm 4, patients will be treated with Placebo 2 ml from Baseline to Week 3

Timeline

• Start date: 2023-10-12
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2024-02-16
• Last updated: 2024-02-16

Locations

11 sites across 1 country: Italy