Phase III Clinical Trial of DP-R206 and Bonvia In Postmen... | NCT01581320

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

NCT01581320

Sponsor

Alvogen Korea

Status

Completed

Last Update Posted

Nov 1, 2016Estimated

Enrollment

201Actual

Phase

Phase 3

Conditions

Postmenopausal Women With Osteoporosis

Interventions

Test group
Reference group

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Feb 26, 2012

First Submission Date that Met QC Criteria

Apr 18, 2012

First Posted Date

Apr 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2016

Last Update Posted Date

Nov 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

201Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DP-R206	Experimental		Drug: Test group
Bonviva	Active Comparator		Drug: Reference group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Test group	Drug	Once a month, administration of DP-R206 & placebo for 16 weeks	DP-R206

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
A ratio of subject whose 25 OHD concentration is less than 9ng/mL	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female more than 40 years old in postmenopausal

Exclusion Criteria:

Subject who has a history of malignant cancer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moo-il Kang, MD, PhD	The Catholic University of Korea	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Catholic University of Korea Seoul St. Mary's Hospital		Seoul		137-701	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C000592733	DP-R206
D004341	Drug Evaluation
D000077557	Ibandronic Acid
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D000076722	Drug Development
D008919	Investigative Techniques
D005069	Evaluation Studies as Topic
D004164	Diphosphonates

Browse Leaves

Not provided

Browse Branches

Not provided