Alfacalcidol in clinical practice: focus on the efficacy and safety of the Russian generic drug

Abstract

The most important factors that determine the risk of fractures are not only the presence of osteoporosis (OP), but also the risk of falls. In addition to sufficient physical activity, medications are needed that have a positive effect on the strength and functional performance of the skeletal muscles. Vitamin D supplements play a key role in this therapeutic approach.Objective: to investigate the tolerability, safety and efficacy of the generic drug Alfacalcidol Canon on the functional status of patients with reduced bone mineral density in clinical practice.Material and methods. The study involved 30 women with OP or osteopenia who were at high risk of falls (mean age 68.0±7.2 years) and who were administered Alfacalcidol Canon at a dose of 1 mcg/day for 3 months. The follow-up period included 4 visits to the clinic, during which laboratory tests were performed and falls and fractures, adverse reactions and patients' adherence to treatment were registered. At the first and last visits, quality of life was assessed using the EQ-5D and the functional status of the skeletal muscles was examined. At the 4th visit, the tolerability of the medication was assessed.Results and discussion. After 3 months of therapy, an increase in muscle strength of the dominant arm was observed by an average of 15.4% (p=0.00002). The time for the "Chair Stand Test" and the "Time up and go" test decreased by 17.4% (p=0.000012) and 13.6% (p=0.00004) respectively. The gait speed test increased on average by 13.9% (p=0.000013), it increased in 26 (86.7%) women. The SPPB test score increased on average by 12.5% (p=0.000001), and achievement of the best indicators was found in 23 (76.7%) women. There were no cases of hypercalcemia, hyperphosphatemia and hypermagnesemia, but 1 case of hypercalciuria was detected. Falls occurred in 2 women (6.7%) who had fallen in the previous year, one of whom suffered a fracture of humeral neck. Adverse reactions were observed in 3 (10 %) women, one of whom stopped taking the drug. 90% of the patients tolerated the treatment excellently. The average compliance rate was 94.3%.Conclusion. Alfacalcidol Canon is a safe and effective drug that can be used to improve the physical performance of skeletal muscles in patients with a high risk of falls.