Abstract
Background: Osteoporosis is a chronic disease and adherence can fluctuate over time. Therefore, longer observation is necessary to investigate the stability of patients' adherence. The study aim was to compare the overall adherence (OA) to supplementation with the fixed combination of calcium and vitamin D (Ca/D) in postmenopausal women at baseline and after 1 year, and to evaluate the fluctuation of the OA in individual months. Furthermore, we studied whether adherence is influenced by signing of informed consent and routine medical check-up.Methods: This was a longitudinal, observational study. The data were obtained from the Osteocenter of University Hospital in Hradec Kralove, Czech Republic. Adherence was measured using electronic bottles type Medication Events Monitoring System (MEMS). The study was carried out in two 3-month periods; the baseline in 2013 (signing of informed consent while medical check-up) and the follow-up (medical check-up) in 2014. The adherence and adherence-related outcomes were studied in patients who had initiated osteoporosis treatment and were persistent.Results: 21 (49%) out of 43 patients who avoided drug dispenser and were persistent both at baseline and at follow-up, completed the study and were included. Median age was 76. Evaluating the whole 3-month periods, the OA did not differ significantly at baseline and at follow-up, the OA was 71 and 68%, respectively. However, the adherence in month 1 at baseline was significantly higher than the adherence in month 2 at baseline (p < 0.001) and also than the adherence in month 1 at follow-up (p = 0.010). Analysing the study period without month 1, a stable adherence was observed in 48% of patients. About 33% of doses were omitted at baseline and 34% at follow-up. As many as 71% of the patients took drug holidays at baseline, and 76% at follow-up.Conclusion: The OA was insufficient, around 70% both at baseline and at follow-up. One half of the patients showed a stable adherence. The patterns of non-adherence were very similar at follow-up. Signing of the informed consent seems to act as bias more than regular medical check-up.
Highlights
Osteoporosis is defined as a chronic systemic disease of skeleton characterized by low bone mineral density which resulted in an increased risk of fractures
According to the study of Tang et al (2007), supplementation with calcium and vitamin D (Ca/D) was associated with a 24% reduction in the fracture risk in patients sufficiently adherent to the supplements
It seems that even though patients have not known about electronic monitoring of adherence, the very fact of signing the informed consent could play the role of bias
Summary
Osteoporosis is defined as a chronic systemic disease of skeleton characterized by low bone mineral density which resulted in an increased risk of fractures. A lot of medications for the treatment of osteoporosis have been proven to reduce fracture risk in postmenopausal women. Antiresorptive drugs, such as bisphosphonates, which prevent accelerated decrease of bone mass associated with age, are widely recommended and used (Kanis et al, 2013). The study aim was to compare the overall adherence (OA) to supplementation with the fixed combination of calcium and vitamin D (Ca/D) in postmenopausal women at baseline and after 1 year, and to evaluate the fluctuation of the OA in individual months. We studied whether adherence is influenced by signing of informed consent and routine medical check-up
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