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

October 31, 2016 updated by: Alvogen Korea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea Seoul St. Mary'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female more than 40 years old in postmenopausal

Exclusion Criteria:

  • Subject who has a history of malignant cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DP-R206
Drug: Test group
Once a month, administration of DP-R206 & placebo for 16 weeks
Other Names:
  • DP-R206 (Test drug)
Active Comparator: Bonviva
Drug: Reference group
Once a month, administration of Bonviva & placebo for 16 weeks
Other Names:
  • Bonviva®
  • (Ibandronate 150mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvogen Korea

Investigators

  • Study Chair: Moo-il Kang, MD, PhD, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

February 26, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP-CTR206-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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