MedDataX Logo

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

NCT ID: NCT01581320

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postmenopausal Women With Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DP-R206

Group Type EXPERIMENTAL

Test group

Intervention Type DRUG

Once a month, administration of DP-R206 \& placebo for 16 weeks

Bonviva

Group Type ACTIVE_COMPARATOR

Reference group

Intervention Type DRUG

Once a month, administration of Bonviva \& placebo for 16 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Test group

Once a month, administration of DP-R206 \& placebo for 16 weeks

Intervention Type DRUG

Reference group

Once a month, administration of Bonviva \& placebo for 16 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DP-R206 (Test drug) <Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU> Bonviva® (Ibandronate 150mg)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female more than 40 years old in postmenopausal

Exclusion Criteria

* Subject who has a history of malignant cancer
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Moo-il Kang, MD, PhD

Role: STUDY_CHAIR

The Catholic University of Korea

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DP-CTR206-03

Identifier Type: -

Identifier Source: org_study_id