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

Several health authorities around the world propose conducting additional observational studies after controlled clinical trials as a part of the regulatory approval process of a drug for marketing. These studies, known as postmarketing surveillance studies, are intended give further insight into the safety, efficacy, and/or optimal use of the drug under the usual conditions of clinical practice. Limited post-marketing studies have been conducted on Risedronate. Therefore, the aim of this study was to evaluate and compare the effect of recent treatment with Risedronate (35 mg) and vitamin D3 (2800 IU) combined in a single pill on bone mineral density in female patients with postmenopausal osteoporosis. Patients were classified according to body mass index criteria. An open-label, observational, post-marketing surveillance study was conducted in a sample group of 345 osteoporosis patients. All patients were allocated according to CONSORT recommendations and treated for 12 months with the study drug. We considered overweight (144) and obese (116) patients as the intervention group and patients with normal weight (84) as the reference group. We excluded one underweight patient from the statistical analysis. Osteoporosis was detected using peripheral bone mineral densitometry. We calculated the number needed to treat for both improvement and no effect on bone mineral density, and we conducted the appropriate statistical analysis. In obese patients, the number needed to treat was 20 and 33, and for overweight patients, the corresponding number was 50 and 20. In conclusion, treatment with Risedronate (35 mg) and vitamin D3 (2800 IU) combined in a single pill showed the most favorable antiresorptive effect in obese osteoporotic patients. These data suggest that health authorities and clinicians should focus on implementing a clinical algorithm that includes screening and monitoring of osteoporotic patients with different body mass indices during treatment Bone remodeling is regulated locally by various hormonal factors, including estrogens, androgens and parathyroid hormone. This latter agent stimulates the hydroxylation of vitamin D in the kidneys and increases the absorption of calcium [11]. Some medical organizations have recommended that bone mineral density (BMD) should be determined in subjects with osteoporotic risk factors because the increase in bone fragility is asymptomatic [4,12]. Osteoporosis risk factors related to weight include a body mass index (BMI) between 20 and 25 kg/m2, body weight less than 40 kg, weight loss greater than 10% of usual body weight in young or adult subjects, or recent weight loss [12]. Bone densitometry (BD) is recognized by WHO as the reference method for the diagnosis of osteoporosis in postmenopausal women because it can be used to quantify BMD with acceptable accuracy and reproducibility [13]. Medical treatment for osteoporosis around the world recommends the use of bisphosphonates as the first-line agents [13]. Administration of Risedronate (5 mg) in postmenopausal women [13-16] every 24 hours for two or three years has been shown to reduce bone turnover [13-15] and increase bone mass in the lumbar spine, femoral neck and trochanter, and to increase Introduction Obesity and osteoporosis are considered to be public health problems worldwide [1], affecting approximately 130 or 500 million people according to the International Osteoporosis Foundation [2] and the World Health Organization [3] (WHO), respectively. Osteoporosis leads to more than 8.9 million fractures annually, of which over 4.5 million occur in Europe and America [4], and this disease is the most common metabolic bone disease in the United States and Mexico. A significant economic cost is associated with osteoporosis [5]. Obesity is the result of chronic excessive storage of body fat due to an imbalance between the intake and expenditure of energy [6]. Osteoporosis is characterized by decreased bone tissue per unit volume of bone [7] and the consequent microarchitectural deterioration of the bone [6-10]. This is associated with increased osteoclast activity, decreased osteoblast activity, or both [11]. Osteoporosis leads to excessive bone fragility and increased susceptibility to future bone fractures [6,8]. Research Article 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 Luis Beltrán-Lagunes1, Silvia Munguía-Lozano1 and Daniel López-Hernández1,2* 1Clinic of Family Medicine “Gustavo A Madero”, Institute of Security and Social Services for State Workers, Mexico 2Department of Biostatistical, Centro de Investigación y de Educación Continua, Mexico *Corresponding author: Daniel López Hernández, Department of Biostatistical, Centro de Investigación y de Educación Continua (CENINVEC), Oyameles No. 30, Postal code 57820, Nezahualcóyotl, Mexico State, Mexico, Tel: +52-55-41-71-93-13; Email: 2003dlopez@gmail.com Received: June 24, 2014; Accepted: July 28, 2014; Published: July 29, 2014 Austin Publishing Group A