Republican Specialized Scientific-Practical Medical Center of Endocrinology; Tashkent, Uzbekistan
*Corresponding author: Prof. Said I. Ismailov, PhD, Scd. Director of the Republican Specialized Scientific-Practical Medical Center of Endocrinology; Tashkent, Uzbekistan. E-mail: firstname.lastname@example.org
Published: September 12, 2016. DOI: 10.21103/Article6(3)_OA6
The aim of this study was to carry out a comparative analysis of the efficiency of ibandronate monotherapy and combined therapies with ibandronate and alfacalcidol in PMO women.
Materials and Methods: A total of 53 women (mean age 60.7 years) with postmenopausal osteoporosis (PMO) were randomized to monotherapy with ibandronate 150 mg/month (Group Ib) (n=25) and therapy with ibandronate 150mg/month plus alpha-D3(AD3)1μg (alfacalcidol) daily (Group Ib+AD3) (n=28). All women received calcium and vitamin D3 supplements. Patients were recruited in one center and were followed up for 6 months on a monthly basis. To assess the efﬁcacy of therapy, BMD was measured at LS (L1–L4) and PF at the beginning and end of therapy by DEXA. Biochemical markers of bone turnover were also assessed.
Results: Statistically signiﬁcant increases in BMD compared with baseline values and the control group were observed in both ibandronate treatment groups. Growth of BMD was significantly higher in Group Ib+AD3 compared to Group Ib. An assessment of CTX dynamics showed a notable decrease in CTX level in patients of both groups compared with levels before treatment. Generally, PTH level decreased insignificantly, but a more pronounced reduction was seen in Group Ib+AD3. TP1NP level significantly increased in Group Ib and was more pronounced in Group Ib+AD3.
Conclusion: Combined therapy with ibandronate sodium and the D-hormone analog alfacalcidol augments the effectiveness of treatment observed in ibandronate sodium monotherapy in PMO women.
Abbreviations: BMD, bone mineral density; LS, lumbar spine; PTH, parathyroid hormone; PF, proximal femur; BTMs, bone turnover markers; CTX, C-terminal telopeptide; TP1NP, type 1 procollagen total N-terminal propeptide.
- Zotkin EG, Safonova YA. Clinical rationale for the use of ibandronate in the treatment of osteoporosis. Effective Pharmacotherapy (Endocrinology). 2011; 2:28-32. [in Russian].
- Marchenkova LA., Prokhorova EA., Dreval’ AV, et al. The influence of postmenopausal osteoporosis and subclinical vertebral fractures on postmenopausal women’s quality of life. Almanac of Clinical Medicine 2014 32:43-49. [in Russian].
- Popov AA, Izmozherova NV, Gavrilov EI, Fominykh MI. Assessing the impact of radial bone fractures on quality of life of residents of Yekaterinburg, suffering from postmenopausal osteoporosis. Osteoporosis and osteopathy 2007;3:9-11. [in Russian].
- Reginster JY, Hiligsmann M, Rabenda V, et al. Ibandronate in the Management of Postmenopausal Osteoporosis. Clinical Medicine: Therapeutics 2009;1:1409–1421.
- Pyadushkina1 EA, Gerasimova KV, Goryainov SV, et al. Comparative pharmacoeconomic analysis of the use of ibandronate (Bonviva®) to prevent fractures in postmenopausal osteoporosis. Modern Reumatology Journal 2012; 4:89-96. [in Russian].
- Aslan A, Sargın S, Özmeriç A, Yağcı Ş. Treatments of patients with postmenopausal osteoporosis: a comparative study. OA Musculoskeletal Medicine 2014;2(1):1-7.
- Bumbasirević M, Lesić A, Denić-Marković L, Zivković K; ORPHEUM Study Group. Prospective clinical study of once monthly ibandronate in the treatment of osteoporosis and prevention of fractures in postmenopausal women: ORPHEUM Study. Srp Arh Celok Lek 2011;139(11-12):790-4.
- Chesnut CH 3rd, Skag A, Christiansen C, Recker R, Stakkestad JA, Hoiseth A, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J. Bone Miner Res. 2004; 19(8):1241–9.
- Miller PD1, Ward P, Pfister T, Leigh C, Body JJ. Renal tolerability of intermittent intravenous ibandronate treatment for patients with postmenopausal osteoporosis: a review. Clin Exp Rheumatol 2008;26:1125–33.
- Stuss M, Sewerynek E, Król I, Stępień-Kłos W, Jędrzejczyk S. Assessment of OPG, RANKL, bone turnover markers serum levels and BMD after treatment with strontium ranelate and ibandronate in patients with postmenopausal osteoporosis. Endokrynologia Polska 2016;67(2):174-84.
- Vujasinović-Stupar N, Milić N, Petrović-Rackov L, Prodanović N, Mijailović-Ivković M, Grujić Z, et al; ESTHER Study Group. Efficacy and safety of once monthly ibandronate treatment in patients with reduced bone mineral density – ESTHER study. Srp Arh Celok Lek 2010138(1-2)56-61.
- Golovach IY. Treatment of osteoporosis in the context of prevention of fractures: implementation of evidence-based medicine in clinical practice. In sight - ibandronic acid Trauma 2013;14 (1) http://www.mif-ua.com [in Russian].
- Dedukh NV. Osteoporosis: a mechanism of therapeutic action bisphosphonates and clinical perspectives. Trauma 2013;14(2) [in Russian].
- Papapoulos S. Ibandronate: a potent new bisphosphonate in the management of postmenopausl osteoporosis. Int J Clin Pract. 2003;57(5):417-22.
- Miller PD, McClung MR, Macovei L, Stakkestad JA, Luckey M, Bonvoisin B, et al. Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE Study. J Bone Miner Res 2005;20(8):1315-22.
- Reginster JY, Adami S, Lakatos P, Greenwald M, Stepan JJ, Silverman SL, et al. Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. Ann Rheum Dis 2006;65(5):654–61.
- Chesnut CH, Ettinger MP, Miller PD, Baylink DJ, Emkey R, Harris ST, et al. Ibandronate produces significant, similar antifracture efficacy in North American and European women: new clinical findings from BONE. Curr Med Res Opin. 2005. 21(3):391-401.
- Reginster JY, Wilson KM, Dumont E, Bonvoisin B, Barrett J. Monthly oral ibandronate is well tolerated and efficacious in postmenopausal women: results from the monthly oral pilot study. J Clin Endocrinol Metab. 2005; 90(9):5018-24.
- Delmas PD, Eastell R, Garnero P, Seibel MJ, Stepan J; Committee of Scientific Advisors of the International Osteoporosis Foundation. The use of biochemical markers of bone turnover in osteoporosis. Osteoporos Int. 2000; 11 Suppl 6:S2–17.
- Belaya ZhE, Rozhinskaya LY. Vitamin D in the treatment of osteoporosis: its role in combination with drugs for the treatment of osteoporosis, extraskeletal effects. Effective pharmacotherapy: Endocrinology 2013;2 (38):14-29. [in Russian]
- Ershova OB. Bisphosphonates in osteoporosis therapy. Focus on alendronate (in Russian). Russian Medical Journal 2008;16(24):1626-1628
- Kostyuchek DF, Dushenkova TA, Rischuk SV. Early diagnosis of osteoporosis in pre- and post-menopausal women. J Obstet Women Dis 2006;55(1):3–7. [in Russian].
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Int J Biomed. 2016;6(3):190-194. © 2016 International Medical Research and Development Corporation. All rights reserved.