ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs

Study Overview
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Brief Summary
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Cross-sectional epidemiological study in patients with diagnosis of osteoarthritis (OA) in order to evaluate risk factors associated with the use / prescription of non-steroidal anti-inflammatory drugs (NSAID).

Detailed Description
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OBJECTIVE: To evaluate the presence of risk factors associated with the use / prescription of non-steroidal anti-inflammatory drugs (NSAID) in patients diagnosed with osteoarthritis (OA). MATERIALS AND METHODS: A multicentric, cross-sectional epidemiological study, will be carried out in patients ≥ 38 years of age, with a previous diagnosis of primary or secondary OA, according to criteria of the American College of Rheumatology (ACR). The presence of at least one risk factor for the use / prescription of NSAIDs is the main variable. The secondary variables to be evaluated include: Demographical characterization of the patients, current disease status (level of pain and functional limitation), treatment (s) used (related or not to OA) and events side effects associated with the treatment (s). The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach.

Official Title
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ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs

Conditions
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Osteoarthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 38 years Previous diagnosis of OSTEOARTRITIS (primary or secondary) at least 30 days before or more, in at least one or more of the following locations: Knee and / or Hip and / or Hand, according to criteria of the American College of Rheumatology (ACR) Exclusion Criteria: Refusal to participate in the study by the patient. Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer to the questions. Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.

Ages Eligible for Study
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Minimum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of risk factors for adverse events associated to consumption of NSAIDs | A descriptive analysis about presence of risk factors for the possible ocurrence of adverse events associated to consumption of NSAIDs in the patients: gastrointestinal, renal, cardiovascular. | It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic analysis | Characterization of patients | It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years | 
| List of drugs used (by the patient) for treatment of osteoarthritis (OA) | List of drugs used (by the patient) for treatment of osteoarthritis (OA), including time of use and posology. | It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years | 
| Evaluation of the current state of the disease according to functional limitation and pain | Evaluation of functional limitation and pain according to the Visual Analogue Scale graduated between 0 and 10, being 0 absence or asymptomatic and 10 the maximum pain or maximum functional limitation. | It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years | 
| Adverse Events related with the treatments | Evaluation of Adverse events associated with the treatment (s) | It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years |