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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).
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.
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Colombian patients, ≥ 38 years, with previous diagnoses of OSTEOARTRITIS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Castillo, Dr | Contact | +571-6461700 | jcastill@scandinavia.com.co | |
| Claudio Ferrari, Dr | Contact | +571-6461700 | cferrari@scandinavia.com.co |
| Name | Affiliation | Role |
|---|---|---|
| Javier Castillo, Dr | Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scandinavia Pharma | Recruiting | Bogotá | 110111 | Colombia |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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 |