Effect of strontium ranelatc (bivalos) on bone mineral density, bone markers and quality of life in the treatment of postmenopausal osteoporosis

The present paper pools the first experience with Bivalos used in therapy for postmenopausal (PM) osteoporosis (OP) in Russia. The main objective of this investigation was to study the impact of one-year Bivalos therapy on spinal bone mineral density (BMD). As secondary end points, the authors evaluated the effects of Bivalos on BMD of the femoral neck and femur as a whole, on the level of bone metabolic markers, the quality of life in patients with OP, and the tolerability of long-term therapy. The study covered 60 females aged 55 to 15 years who had PMOP treated in 3 Moscow medical centers (Endocrinology Research Center; Institute of Rheumatology, Russian Academy of Medical Sciences; N. N. Priorov Central Institute of Traumatology and Orthopedics) with 20 patients in each center. At 1 year of Bivalos use, there were significant increases of BND in the lumbar vertebrae by 4.68±4.94%, femoral neck by 2.0±4.29% and in the overall index of BMD in the proximal femur by 3.10±3.34%. Assessing the time course of changes in bone metabolism markers revealed a statistically significant increment in bone alkaline phosphatase by 19.5% and a reduction in C-terminal telopeptide collagen type 1 by 16.57c, which supports the heterodirectionai effect of Bivalos on osteogenesis and bone tissue. Bivalos therapy improved quality of life, extended motor activity, diminished depression, increased self-assessment, decreased the number of patients with spinal pain, relieved pain, and reduced the frequency of its occurrence. Bivalos was well tolerated; the incidence of adverse reactions was not greater than 15% and the drug discontinuance was required in 5% of cases. No serious side effects were observed. Despite the fact that an open-labeled uncontrolled clinical study had been conducted, our results were consistent with those of multicenter double-blind placebo-controlled studies in larger groups.

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