NCT01675297

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,053 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Risedronate/Cholecalciferol combination	Risendronate/Cholecalciferol combination once a week
DRUG	Risedronate	Risedronate once a week

Timeline

• Start date: 2011-07-04
• Primary completion: 2013-12-01
• Completion: 2014-04-15
• First posted: 2012-08-29
• Last updated: 2019-08-05
• Results posted: 2019-08-05

Locations

1 site across 1 country: South Korea