Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis

Phase 3

Completed

• Conditions: Postmenopausal Women With Osteoporosis
• Interventions: Drug: Test group; Drug: Reference group

• Registration Number: NCT01581320
• Lead Sponsor: Alvogen Korea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-26
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-20
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 201

Inclusion Criteria

• Female more than 40 years old in postmenopausal

Exclusion Criteria

• Subject who has a history of malignant cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DP-R206	Test group	-
Bonviva	Reference group	-

Primary Outcome Measures

Name	Time	Method
A ratio of subject whose 25 OHD concentration is less than 15ng/mL	16weeks	A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks

Secondary Outcome Measures

Name	Time	Method
A ratio of subject whose 25 OHD concentration is less than 9ng/mL	16 weeks	A ratio of subject whose 25 OHD concentration is less than 9ng/mL after 16weeks
Safety evaluation (AE, Lab test, Vital sign etc)	16weeks

Trial Locations

Locations (1)

The Catholic University of Korea Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of