Conditions: Osteoporosis
Keywords: Risedronate, cholecalciferol, BMD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1053
Healthy volunteers: no

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

Detailed description:
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.

Arms:
arm 1: Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months arm 2: Sedron tablet: one tablet once a week for 12months

Interventions: intervention 1: Risedronate/Cholecalciferol combination intervention 2: Risedronate
Intervention descriptions: intervention 1: Risendronate/Cholecalciferol combination once a week intervention 2: Risedronate once a week

Protocol document: