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

NCT01581320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2016-11-01

No results posted yet for this study

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.

Conditions

  • Postmenopausal Women With Osteoporosis

Interventions

DRUG

Test group

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

DRUG

Reference group

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

Sponsors & Collaborators

  • Alvogen Korea

    lead INDUSTRY

Principal Investigators

  • Moo-il Kang, MD, PhD · The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01581320 on ClinicalTrials.gov