INTRAMUSCULAR INJECTIONS OF CLODRONIC ACID IN THE FORMULATION OF 200 Mg IN THE TREATMENT OF HAND OSTEOARTHRITIS PAINFUL - FIRST STUDY TO EVALUATE THE ABILITY TO ACT DRUG IN IMPROVING SYMPTOMS OF DISEASE

Phase 1

Conditions: Painful osteoarthritis of the hands
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-000832-85-IT

Lead Sponsor: Fondazione Salvatore Maugeri, IRCCS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

° male and female population over 18 years
° erosive osteoarthritis diagnosed according to international radiological criteria (at least 2 interphalangeal joints in erosive phase) or primary osteoarthritis of the hands diagnosed according to clinical ACR steroid therapy and DMOADs any suspended for at least three months, including infiltration
° phase algic in place to load interphalangeal hands with VAS ? 4 cm/10
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

° erosive osteoarthritis and primary osteoarthritis in inactive phase and not algic
° with osteoarthritis of the hands with functional impairment no longer editable (ankylosis)
° patients with digestive diseases that contraindicate the use of NSAIDs
° suffering from kidney disease, cardiovascular and neoplastic
° suffering from systemic diseases and non-severe, not yet stabilized
° suffering from psychiatric and / or neurological relevant
° suffering from rheumatism, fibromyalgia primary or secondary
° syndromes of the upper canalicular
° suffering from chronic inflammatory arthropathy albeit temporarily in remission.
° those who take illegal drugs and / or alcohol in doses which constitute abuse.
° patients with known or suspected hypersensitivity to bisphosphonates
° subjects presenting contraindication to the use of NSAIDs
° subjects not willing to give their informed consent to participation in the study and patients who do not ensure adequate adherence to the study requires.
° patients who are pregnant or nursing, or who have good chance of it during the course of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and tolerability of cyclic administration of 200 mg intramuscular injection of clodronate in patients with erosive osteoarthritis of the hands being algic and nodal osteoarthritis of the hands being algic measured by grip strength and the index of Dreiser;Secondary Objective: Effectiveness assessment of pain relief through the consumption of NSAID-pain relievers.;Primary end point(s): To evaluate the efficacy and tolerability of cyclic administration of 200 mg intramuscular injection of clodronate in patients with erosive osteoarthritis of the hands being algic and nodal osteoarthritis of the hands being algic measured by grip strength and the index of Dreiser;Timepoint(s) of evaluation of this end point: 6 month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Effectiveness assessment of pain relief through the consumption of NSAID-pain relievers.;Timepoint(s) of evaluation of this end point: 6 month