Compliance, persistence and preference outcomes of Postmenopausal Osteoporotic Women receiving a flexible or fixed regimen of daily Risedronate
- Flexible dosing resulted in better persistence rates than fixed dosing but did not affect compliance rates.
- There was no difference between fixed and flexible dosing in the efficacy of Risedronate on the decrease of bone turnover markers as shown by change in NLX-1 levels.
Medications for the treatment of postmenopausal osteoporosis (OP) require years of persistence and proper compliance to successfully achieve the goal of reducing fracture risk. Among bisphosphonates, Risedronate at a daily dose of 5 mg has been shown to reduce the risk of fracture and can be administered in one of three different timing regimens unlike other oral bisphosphonates.
Medications for the treatment of postmenopausal osteoporosis (OP) require years of persistence and proper compliance to successfully achieve the goal of reducing fracture risk. Among bisphosphonates, Risedronate at a daily dose of 5 mg has been shown to reduce the risk of fracture and can be administered in one of three different timing regimens unlike other oral bisphosphonates. Three studies exploring the effects of Risedronate dosing at a time other than before breakfast on bone mineral density (BMD) and/or on bone turnover markers (BTMs) have provided information on compliance while other two studies gave information on persistence only and this ultimately signifies little information on patient’s level of compliance and persistence.
- Rationale behind research
- Little information is available on patient’s level of compliance and persistence with instructions to take medication at specific times of day or within specified amounts of time in relation to food
- This study was conducted to examine the compliance, persistence and preference between a fixed or flexible dosing regimen of daily Risedronate in patients with postmenopausal OP
To examine the level of compliance and persistence in patients with postmenopausal OP receiving daily Risedronate (5 mg) with either fixed dosing or with flexible dosing and the effect on urinary N-terminal telopeptide of Type 1 collagen (NTX-1)
Response: Combination of the compliance and persistence
- Compliance: Frequency of all treatment adverse events, questionnaire on subject’s preference and opinion of Risedronate treatment
- Persistence: Urinary NTX-1 levels associated with improved persistence
- Patients’ opinion of Risedronate treatment: Baseline, 3rd and 26th week
- Urinary NTX-1 levels: Baseline, 13th and 26th week
- Baseline: The groups were well balanced at baseline with no statistically significant difference
- The persistence rate in flexible regimen (86.0%) was significantly higher than fixed regimen (78.9%) (p=0.0306). The difference in terms of compliance was not statistically significant (p=0.4611). In fixed dosing group, the patients taking their medication before bedtime had higher compliance and persistence rates
- At 26th week, 50.8% of the patients in flexible and 55.8% in fixed regimen group considered the used Risedronate regimen as excellent or very good (p= 0.1440)
- At 26th week, there was no difference between fixed and flexible dosing in efficacy of Risedronate on the decrease of bone turnover markers as shown by change from baseline in NTX- 1 levels
Figure1: Urinary NTX-1 levels
- Adverse events were few and mild in nature, mainly affecting the upper gastrointestinal system
Flexible dosing resulted in better persistence rates than fixed dosing but did not affect compliance rates. A similar percentage of patients preferred daily flexible and fixed dosing, and both regimens were rated as excellent or very good by the patients. As approved treatment regimens vary between countries, these findings may not be applicable worldwide and additional large-scale studies including categorical evaluation of MPR, measurement of change in BMD and the assessment of the additional factors likely to influence compliance and/or persistence will enable more accurate assessment of compliance and persistence with daily Risedronate regimens in patients with postmenopausal OP.
In this study, the persistence levels in the flexible (86.0%) and fixed (78.9%) regimen groups were higher than those in literature. The differences are might be due to the difference in methodology between clinical studies and real-world setting. Siris et al. found that medication possession ratio of ≥ 50% was associated with substantial fracture reduction. Similar results have been seen with bisphosphonates in compliant and/or persistent patients in both randomized clinical trials and real world practice in terms of fracture risk reduction.