Efficacy and safety of bivalos therapy for postmenopausal osteoporosis. Results of Russian multicenter trial

• Published in: Terapevtic̆eskii arhiv Vol. 80; no. 5; pp. 47 - 52
• Main Authors: Rozhinskaia, L Ia, Arapova, S D, Dzeranova, L K, Molitvoslovova, N N, Marova, E I, Il'in, A V, Benevolenskaia, L I, Nikitinskaia, O A, Korotkova, T A, Toroptsova, N V, Smirnov, A V, Demin, N V, Rodionova, S S, Buklemeshev, Iu V, Shumskiĭ, A A
• Format: Journal Article
• Language: Russian
• Published: Russia (Federation) "Consilium Medicum" Publishing house 01.01.2008
• Subjects: Absorptiometry, Photon; Administration, Oral; Aged; bivalos; Bone Density - drug effects; Bone Density Conservation Agents - administration & dosage; Bone Density Conservation Agents - therapeutic use; Cytokines - blood; Dose-Response Relationship, Drug; Female; Femur - diagnostic imaging; Femur - metabolism; Humans; Immunoenzyme Techniques; Lumbar Vertebrae - diagnostic imaging; Lumbar Vertebrae - metabolism; Middle Aged; Organometallic Compounds - administration & dosage; Organometallic Compounds - therapeutic use; osteoporosis; Osteoporosis, Postmenopausal - diagnostic imaging; Osteoporosis, Postmenopausal - drug therapy; Osteoporosis, Postmenopausal - metabolism; postmenopausal period; strontium ranelat; Thiophenes - administration & dosage; Thiophenes - therapeutic use; treatment; Treatment Outcome
• ISSN: 0040-3660; 2309-5342

To study effects of one-year therapy with bivalos on mineral bone density (MBD) of the spine in patients with postmenopausal osteoporosis (PMO), effects of bivalos (strontium ranelate) on MBD of the neck of the femur and femur, the levels of bone metabolism markers, quality of life, tolerance of long-term therapy. The study was made of 60 females aged 54-75 years with PMO. MBD was measured with x-ray absorptiometry in the vertebra and proximal femur. Bone markers in blood serum were detected by enzyme immunoassay. After a year of taking bivalos MBD in lumbar vertebra increased by 4.68 +/- 4.94%, in the neck of the femur--by 2.0 +/- 4.29%, in the proximal femur--by 3.10 +/- 3.34%. A significant 19.5% rise in bone alkaline phosphatase and a 16.5% fall in the level of CT were noted showing a stimulating effect of bivalos on bone formation and an inhibiting effect--on bone tissue resorption. Bivalos treatment raised quality of life of the patients: better motility, regress of depression, improved self-appraisal, decreased number of patients with pain in the spine, attenuated pain. The drug was well tolerated, unwanted effects arose in 15% patients, discontinuation of the drug because of toxicity occurred in 5%. Serious side effects were not observed. Strontium ranelate is effective in PMO and is well tolerated.