A Prospective Non-Interventional Study on STRUctum® in Adult Patients with oSTeoarthritis – TRUST

How is the study conducted?

The study was an observational, real-world study conducted over a 6-month period.
Observational means doctors do not change the usual care of the participants. They only collect information during usual visits. No extra tests or visits were required for the study. Participants usually have 2 follow-up visits: after 3 months and after 6 months. People had to fill out 4 questionnaires at each visit related to the severity of the disease, its burden, general health, quality of life, and their level of satisfaction with Structum®.

Who can take part in the trial ?

The study took place in Poland.

The following people that fulfilled the following criteria could participate in the study:

Adults aged 50 to 85 years (because knee osteoarthritis is more common in this age group)
Diagnosed with knee osteoarthritis
Treated with Structum®
With dosage of osteoarthritis pain medication stable at least one week prior to study entry, if any
Participants able to visit the health care facility
Who agreed to participate in the study

What are the objectives of the trial and how are they evaluated ?

The primary objective was to describe the characteristics of the people treated with Structum®. The severity of their knee osteoarthritis was also described. The severity was evaluated using a questionnaire named Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

The secondary objectives were to describe over 6-month follow-up:

The severity of the knee osteoarthritis
The burden associated with knee osteoarthritis using a questionnaire named BONe’S
The general health and quality of life using a questionnaire named SF-12
How many people were taking Structum®
How people were satisfied with Structum®

What is the study Medication ?

People included in the study took Structum® daily prescribed by their doctor according to local clinical practices. The prescription followed the instructions for doctors on how to use safely Structum®.

More information

This study was conducted according to ethical considerations and followed the rules for conducting such a study. The study was approved by health authorities before it started. People signed a consent form to confirm they agreed to participate.