NCT01581320
Completed
Phase 3
A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R206 and Bonviva for the Improvement of Vitamin D in Postmenopausal Women With Osteoporosis
Alvogen Korea1 site in 1 country201 target enrollmentDecember 2011
ConditionsPostmenopausal Women With Osteoporosis
Overview
- Phase
- Phase 3
- Intervention
- Test group
- Conditions
- Postmenopausal Women With Osteoporosis
- Sponsor
- Alvogen Korea
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- A ratio of subject whose 25 OHD concentration is less than 15ng/mL
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female more than 40 years old in postmenopausal
Exclusion Criteria
- •Subject who has a history of malignant cancer
Arms & Interventions
DP-R206
Intervention: Test group
Bonviva
Intervention: Reference group
Outcomes
Primary Outcomes
A ratio of subject whose 25 OHD concentration is less than 15ng/mL
Time Frame: 16weeks
A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks
Secondary Outcomes
- A ratio of subject whose 25 OHD concentration is less than 9ng/mL(16 weeks)
- Safety evaluation (AE, Lab test, Vital sign etc)(16weeks)
Study Sites (1)
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