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

Information source: DreamPharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopausal Women With Osteoporosis

Intervention: Test group (Drug); Reference group (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: DreamPharma

Official(s) and/or principal investigator(s):
Moo-il Kang, MD, PhD, Study Chair, Affiliation: The Catholic University of Korea

Overall contact:
Jae-Won Lee, PhD, Phone: 82-2-729-4125, Email: jwleeg@hanwha.co.kr

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: A ratio of subject whose 25 OHD concentration is less than 15ng/mL

Secondary outcome:

A ratio of subject whose 25 OHD concentration is less than 9ng/mL

Safety evaluation (AE, Lab test, Vital sign etc)

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female more than 40 years old in postmenopausal

Exclusion Criteria:

- Subject who has a history of malignant cancer

Locations and Contacts

Jae-Won Lee, PhD, Phone: 82-2-729-4125, Email: jwleeg@hanwha.co.kr

The Catholic University of Korea Seoul St. Mary's Hospital, Seoul 137-701, Korea, Republic of; Recruiting
Sunhee Ko, MD, Phone: 82-2-2258-6006, Email: kshpeter@catholic.ac.kr
Additional Information

Starting date: January 2012
Last updated: April 18, 2012

Page last updated: August 23, 2015

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