Background: Poor persistence with oral bisphosphonates and other oral medications led to an increasing usage of intravenous regimens for the treatment of patients at risk of or with osteoporotic fractures. However, intravenous bisphosphonates may be accompanied by unpleasant side effects and inconvenient application. Therefore, subcutaneously administered Denosumab (DMAb) twice yearly was anticipated to possibly overcome those disadvantages and eventually improve persistence. The objective of this prospective observational study was to evaluate the persistence with DMAb in the real-world setting of a menopause and osteoporosis outpatient clinic in Austria.
Methods: 554 postmenopausal women with osteoporosis (defined by WHO criteria), 50 to 94 years of age, were studied to measure persistence with DMAb treatment between Sept. 2010 to Dec. 2014. Patients were monitored to evaluate tolerance and safety as well as efficacy by assessing side effects, adverse events and discontinuation of therapy as well as diverse parameters of bone metabolism in 6 months intervals.
Results: According to the cumulative numbers of patients lost to follow-up and to discontinuation of therapy, persistence was 92,2% at month 6, 88,1% at month 12, 85,4% at month 18, 83,0% at month 24, 81,4% at month 36 and 80,9% at month 48. The numbers of patients lost to follow-up and discontinuing therapy were highest at month 6 - 24 and 19 respectively out of 554 women - and decreased to 1 and 2 respectively out of 215 at month 36 and to zero out of 81 at month 48.
Discussion: The high rate of persistence with DMAb, in comparison to reported rates of other bone-specific regimens in the literature, may be attributed to a low frequency of side effects and adverse events with a concurrently high efficacy and a very comfortable way of administration.
Disclosure: The authors declared no competing interests.