NCT01581320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 1, 2016

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

February 26, 2012

Last Update Submit

October 31, 2016

Conditions

Postmenopausal Women With Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • A ratio of subject whose 25 OHD concentration is less than 15ng/mL

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

    16weeks

Secondary Outcomes (2)

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

    16 weeks

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

    16weeks

Study Arms (2)

DP-R206

EXPERIMENTAL
Drug: Test group

Bonviva

ACTIVE COMPARATOR
Drug: Reference group

Interventions

Test groupDRUG

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

Also known as: DP-R206 (Test drug), <Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU>
DP-R206
Reference groupDRUG

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

Also known as: Bonviva®, (Ibandronate 150mg)
Bonviva

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female more than 40 years old in postmenopausal

You may not qualify if:

  • Subject who has a history of malignant cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 137-701, South Korea

Location

MeSH Terms

Interventions

DP-R206Drug EvaluationIbandronic AcidCholecalciferol

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as TopicDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Moo-il Kang, MD, PhD

    The Catholic University of Korea

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2012

First Posted

April 20, 2012

Study Start

December 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 1, 2016

Record last verified: 2012-04

Locations

KR(1)