Knee osteoarthritis MedDRA version: 9.1 Level: LLT Classification code 10048794 Term: Gonarthrosis
Conditions
Interventions
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-
Phar
Sponsors
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Osteoarthrtis secondary to other joint diseases, corticosteroid therapy during previous 30 days or NSAIDs therapy during previous 4 days; previous major surgery in the kenn, or arthroscopy within previous 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Pain reduction based on VAS scale and on joint tenderness evaluation.;Secondary Objective: Functional improvement; paracetamol consumption; tolerability; global assessment by patient and by clinician; quality of life.;Primary end point(s): Pain reduction based on VAS scale | — |
Countries
Italy
Outcome results
None listed