Evaluation of compliance, persistence, safety profile and satisfaction to monthly single-pill treatment regimen of ibandronic acid 150 mg and cholecalciferol 22,400 IU among postmenopausal women with osteoporosis.

OBJECTIVE

Osteoporosis is an important public health concern for postmenopausal women and needs effective treatments to alleviate the risk of fractures and associated complications. This study aimed to evaluate treatment compliance, persistence, satisfaction, and safety of the monthly single-pill treatment regimen of ibandronic acid 150 mg and cholecalciferol 22,400 IU in postmenopausal women with osteoporosis at risk for vitamin D insufficiency and fractures (The TÉSIS study).

METHODS

This non-interventional, multicenter, single-arm, prospective study included postmenopausal female patients from community pharmacies in Portugal. Two patient visits were conducted: the initial visit and the final follow-up visit after six months. Treatment compliance, persistence, and safety were evaluated using patient diaries, investigator notes, internal pharmacy sales information, and structured study questionnaires. Treatment satisfaction was assessed through the Osteoporosis Treatment Patient Satisfaction Questionnaire (OPSAT-Q).

RESULTS

Of 230 enrolled patients, 211 completed both visits. At the final visit, the average treatment compliance (n = 180) was 98.7%, and 85.8% of patients remained persistent (n = 211). OPSAT-Q satisfaction scores (n = 202) were 81.69 (composite satisfaction score (CSS)-1) and 82.74 (CSS-2), indicating high satisfaction, favoring the treatment. Arthralgia and dyspepsia were the most frequently reported adverse reactions (6.2%). No significant differences were observed in treatment compliance, persistence, and satisfaction between first-time (n = 65) and previous users (n = 146) of the monthly single-pill treatment regimen of ibandronic acid 150 mg and cholecalciferol 22,400 IU.

CONCLUSION

The monthly single-pill treatment regimen of ibandronic acid 150 mg and cholecalciferol 22,400 IU demonstrated high treatment compliance, persistence and patient satisfaction with a favorable safety profile and was well tolerated after six months of treatment.