Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis.

The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.

Inclusion Criteria:

1. Male osteoporosis patients over 19 years of age

2. Female osteoporosis patients with menopause

   • Definition of osteoporosis

     • They had a BMD T-score -2.5 or less at mean Lumbar spine(L1-L4), Femoral neck or total. Or evidence of at least one vertebral fracture

   • Definition of menopause(can be one of three condition)

     • For 12months spontaneous amenorrhea
     • For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40mlU/mL and over
     • 6weeks after bilateral ovariectomy whether hysterectomy or not.

Exclusion Criteria:

1. Patients with esophagus disorder (i.e:esophagostenosis)
2. Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
3. Patients with serum calcium concentrations 8.0mg under
4. Patients with severe nephropathy (CCr 30mL/min less)
5. Patients with unable to sit upright or stand for 30minutes