Efficacy of Risedronate and Vitamin D3 Once-weekly on Bone Mineral Density in Women Patients with Osteoporosis
Clinical Medicine Research
Volume 8, Issue 5, September 2019, Pages: 93-100
Received: Aug. 10, 2019;
Accepted: Sep. 10, 2019;
Published: Sep. 30, 2019
Views 413 Downloads 121
Daniel Lopez-Hernandez, Sub-Directorate of Prevention and Health Protection, Institute of Security and Social Services of State Workers, Mexico City, Mexico; Department of Biostatistics and Epidemiology, Center for Research and Continuing Education (CENINVEC), Nezahualcoyotl City, Mexico
Nadhyieli Orozco-Campos, Sub-Directorate of Prevention and Health Protection, Institute of Security and Social Services of State Workers, Mexico City, Mexico
Leticia Brito-Aranda, Department of Biostatistics and Epidemiology, Center for Research and Continuing Education (CENINVEC), Nezahualcoyotl City, Mexico
Maria de la Luz Lopez-Hernandez, Department of Biostatistics and Epidemiology, Center for Research and Continuing Education (CENINVEC), Nezahualcoyotl City, Mexico
Aurora Bautista-Marquez, Sub-Directorate of Prevention and Health Protection, Institute of Security and Social Services of State Workers, Mexico City, Mexico
Vesta Richardson, Sub-Directorate of Prevention and Health Protection, Institute of Security and Social Services of State Workers, Mexico City, Mexico
There has been a limited evaluation of the efficacy of administered vitamin-D3 and bisphosphonate in a single pill (once-weekly) on changes of Bone Mineral Density (BMD), speciality in elderly people. To evaluate the changes in BMD, using Risedronate and vitamin D3, in patients from the first level of primary care after a period of more than 2 years of follow-up. An observational and retrospective cohort study, in a non-controlled, real-life setting nested to a database was designed. Records of participants between March-04-2008 and June-27-2012. Mexican patients from 21 Clinics of Family Medicine. The database is characterized by all patients received Risedronate (35 mg) and vitamin-D3 (2800 IU) combined in a single pill, administered once-weekly. BMD was determined in the distal portion of the radius bone using an Omnisense-7000S bone densitometer. The Kaplan-Meier method was used to estimate cumulative probabilities. Hazard ratios (HRs) were estimated using Cox-proportional hazard-models. A total of 14,721 women were included. The mean time of treatment was 27.06 months (interquartile-range=26.00-29.00); the crude HR in patients with osteoporosis was 2.483 (95%CI 1.806-3.414) times higher than their counterparts with osteopenia. In relation to age, the increase in BMD was 26% higher (HR=0.739; 95%CI 0.712-0.766) in patients with 60 or more age than their counterparts aged ≤59 years. The duration of treatment with risedronate/vitamin D3 once-weekly depends on the target population and need strict monitoring of BMD particularly for those patients who have a treatment for more of 18 months due to the risk of decreased BMD.
Maria de la Luz Lopez-Hernandez,
Efficacy of Risedronate and Vitamin D3 Once-weekly on Bone Mineral Density in Women Patients with Osteoporosis, Clinical Medicine Research. Special Issue: Globalization and Advances on Non-Communicable Chronic Diseases.
Vol. 8, No. 5,
2019, pp. 93-100.
International Osteoporosis Foundation. Osteoporosis Facts and Statistics. IOF Data & Publications Website, Available: https://www.iofbonehealth.org/facts-statistics#category-14 Accessed 24 October 2016.
World Health Organization. WHO Scientific group of the assessment of osteoporosis at primary health care level. Summary Meeting Report Brussels, Belgium, 5-7 May 2004; Geneva, 2007.
Padilla-Vázquez AV, Lamadrid-Figueroa H, Cruz-Valdez A. [Weight, fat percentage and maternal bone mineral density are determinants of bone mineral density in adolescent and young adult females]. Bol Med Hosp Infant Mex. 2007; 64: 72-82. [Article in Spanish].
Mortensen L, Charles P, Bekker PJ, et al. Risedronate increases bone mass in an early postmenopausal population: two years of treatment plus one year of follow-up. J Clin Endocrinol Metab. 1998; 83 (2): 396-402.
Fogelman I, Ribot C, Smith R, et al. Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. BMD-MN Study Group. J Clin Endocrinol Metab. 2000 May; 85 (5): 1895-900.
Harris ST, Watts NB, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. JAMA. 1999; 282 (14): 1344-52.
Reginster JY, Minne HW, Sorensen OH, et al. Randomized trial the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int. 2000; 11: 83-91.
Brown JP, Kendler DL, McClung MR, et al. The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif Tissue Int. 2002; 71 (2): 103-11.
Rosen CJ, Hochberg MC, Bonnick SL, et al. Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study. J Bone Miner Res. 2005; 20 (1): 141-51.
Boonen S, Orwoll ES, Wenderoth D, et al. Once-weekly risedronate in men with osteoporosis: results of a 2-year, placebo-controlled, double-blind, multicenter study. J Bone Miner Res. 2009; 24 (4): 719-25.
Chung HY, Chin SO, Kang MI, et al. Efficacy of risedronate with cholecalciferol on 25-hydroxyvitamin D level and bone turnover in Korean patients with osteoporosis. Clin Endocrinol (Oxf). 2011; 74 (6): 699-704.
Reid DM, Hughes RA, Laan RF, et al. Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial. European Corticosteroid-Induced Osteoporosis Treatment Study. J Bone Miner Res. 2000; 15 (6): 1006-13.
McClung MR, Miller PD, Brown JP, et al. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporos Int. 2012; 23 (1): 267-76.
Kishimoto H. Efficacy and tolerability of risedronate for the treatment of osteoporosis. Clin Calcium. 2008; 18 (10): 1417-26.
Eastell R, Barton I, Hannon RA, et al. Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate. J Bone Miner Res. 2003; 18 (6): 1051-6.
Seibel MJ, Naganathan V, Barton I, et al. Relationship between pretreatment bone resorption and vertebral fracture incidence in postmenopausal osteoporotic women treated with risedronate. J Bone Miner Res. 2004; 19 (2): 323-9.
Watts NB, Geusens P, Barton IP, et al. Relationship between changes in BMD and nonvertebral fracture incidence associated with risedronate: reduction in risk of nonvertebral fracture is not related to change in BMD. J Bone Miner Res. 2005 Dec; 20 (12): 2097-104.
Zoehrer R, Roschger P, Paschalis EP, et al. Effects of 3- and 5-year treatment with risedronate on bone mineralization density distribution in triple biopsies of the iliac crest in postmenopausal women. J Bone Miner Res. 2006; 21 (7): 1106-12.
Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014; 25 (10): 2359–2381. Published online 2014 Aug 15. doi: 10.1007/s00198-014-2794-2.
Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R,. Reginster J-Y, et al. European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2013; 24 (1): 23–57. Published online 2012 Oct 19. doi: 10.1007/s00198-012-2074-y.
Robert AA, Fuleihan GE-H, Bauer DC, Camacho PM, Clarke BL, Clines GA, et al. Managing Osteoporosis Patients after Long-Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2016; 31 (1): 16–35. doi: 10.1002/jbmr.2708
Luis Beltrán-Lagunes, Silvia Munguía-Lozano, Daniel López-Hernández. The effect on bone mineral density in patients with osteoporosis and obesity of once-weekly treatment with Risedronate/vitamin D3 combined in a single pill for 12 months: A post-marketing study. Austin Journal of Endocrinology & Diabetes. 2014; 1 (4): 8.
Delmas PD, Benhamou CL, Man Z, Tlustochowicz W, Matzkin E, Eusebio R, et al. Monthly dosing of 75 mg risedronate on 2 consecutive days a month: efficacy and safety results. Osteoporos Int. 2008 Jul; 19 (7): 1039-45.
Delmas PD, McClung MR, Zanchetta JR, Racewicz A, Roux C, Benhamou CL, et al. Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis. Bone. 2008 Jan; 42 (1): 36-42.
McClung MR, Zanchetta JR, Racewicz A, Roux C, Benhamou CL, Man Z, et al. Efficacy and safety of risedronate 150-mg once a month in the treatment of postmenopausal osteoporosis: 2-year data. Osteoporos Int. 2013; 24 (1): 293-9.
Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int. 2000; 11: 83-91.
Ellis AG, Reginster JY, Luo X, Cappelleri JC, Chines A, Sutradhar S, et al. Bazedoxifene versus Oral Bisphosphonates for the Prevention of Nonvertebral Fractures in Postmenopausal Women with Osteoporosis at Higher Risk of Fracture: A Network Meta-Analysis. Value Health. 2014; 17: 424-432.
Obermayer-Pietsch B, Chararas C, Kotschan S, Walter D, Leb G. Genetic background of osteoporosis. Acta Med Austriaca. 2000; 27 (1): 18-22.
Stewart TL, Ralston SH. Role of genetic factors in the pathogenesis of osteoporosis. J. Endocrinol. 2000; 166 (2): 235-45.
Ma X, Chen Y, Zhang Q, Tian H, Wang J, Liu S, et al. Interleukin-16 rs11556218 is associated with a risk of osteoporosis in Chinese postmenopausal women. Eur J Obstet Gynecol Reprod Biol. 2016; 210: 90-93.
Fajar JK, Azharuddin A. The association between interleukin 6−174 G/C gene polymorphism and the risk of osteoporosis: A meta-analysis. Journal of Taibah University Medical Sciences, In press, corrected proof, Available online 6 October 2016.
Kotrych D, Dziedziejko V, Safranow K, Sroczynski T, Staniszewska M, Juzyszyn Z, et al. TNF-α and IL10 gene polymorphisms in women with postmenopausal osteoporosis. Eur J Obstet Gynecol Reprod Biol. 2016; 199: 92-5.
Sun T, Chen M, Lin X, Yu R, Zhao Y, Wang J. The influence of osteoprotegerin genetic polymorphisms on bone mineral density and osteoporosis in Chinese postmenopausal women. Int Immunopharmacol. 2014; 22 (1): 200-3.
Zhang Y, Ma C, Liu X, Wu Z, Yan P, Ma N, et al. Epigenetic landscape in PPARγ2 in the enhancement of adipogenesis of mouse osteoporotic bone marrow stromal cell. Biochim Biophys Acta. 2015; 1852 (11): 2504-16.
Tamura Y, Kawao N, Yano M, Okada K, Matsuo O, Kaji H, et al. Plasminogen activator inhibitor-1 deficiency ameliorates insulin resistance and hyperlipidemia but not bone loss in obese female mice. Endocrinology. 2014; 155: 1708-1717.
Mazziotti G, Bilezikian J, Canalis E, Cocchi D, Giustina A. New understanding and treatments for osteoporosis. Endocrine. 2012; 41: 58-69.
Ogata N, Chikazu D, Kubota N, Terauchi Y, Tobe K, Azuma Y, et al. Insulin receptor substrate-1 in osteoblast is indispensable for maintaining bone turnover. J Clin Invest. 2000; 105: 935-943.
Cao JJ, Sun L, Gao H. Diet-induced obesity alters bone remodeling leading to decreased femoral trabecular bone mass in mice. Ann N Y Acad Sci. 2010; 1192: 292-297.
López-Hernández D. Polymorphisms of cytochrome P450 are potential candidates that could potentially help clinicians on the treatment of cardiovascular diseases among Asian populations. Indian Heart J (2017), http://dx.doi.org/10.1016/j.ihj.2017.02.016.