Randomized clinical trial on efficacy and tolerability of intra-articular clodronate compared to placebo in knee osteoarthritis

INTERVENTION: Trade Name: CLODRONATO ABC Pharmaceutical Form: Solution for injection INN or Proposed INN: Clodronic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraarticular use CONDITION: Knee osteoarthritis ; MedDRA version: 9.1 Level: LLT Classification code 10048794 Term: Gonarthrosis PRIMARY OUTCOME: Main Objective: Pain reduction based on VAS scale and on joint tenderness evaluation. Primary end point(s): Pain reduction based on VAS scale Secondary Objective: Functional improvement; paracetamol consumption; tolerability; global assessment by patient and by clinician; quality of life. INCLUSION CRITERIA: Men and women aged 50 to 75 years with knee osteoarthritis according to ACR criteria, radiologically confirmed, with a Kellgren/Lawrence grade of 2 and 3; starting spontaneous pain >= 40 on a VAS of 0 to 100 and functional disability >=2 on a scale of 1 to 4; informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range