Back to resultsPhase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis (DIOS)
Primary Purpose
Postmenopausal Women With Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Test group
Reference group
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Women With Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Female more than 40 years old in postmenopausal
Exclusion Criteria:
- Subject who has a history of malignant cancer
Sites / Locations
- The Catholic University of Korea Seoul St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DP-R206
Bonviva
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Safety evaluation (AE, Lab test, Vital sign etc)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01581320
Brief Title
Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis
Acronym
DIOS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alvogen Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Women With Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DP-R206
Arm Type
Experimental
Arm Title
Bonviva
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Test group
Other Intervention Name(s)
DP-R206 (Test drug), <Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU>
Intervention Description
Once a month, administration of DP-R206 & placebo for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Reference group
Other Intervention Name(s)
Bonviva®, (Ibandronate 150mg)
Intervention Description
Once a month, administration of Bonviva & placebo for 16 weeks
Primary Outcome Measure Information:
Title
A ratio of subject whose 25 OHD concentration is less than 15ng/mL
Description
A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks
Time Frame
16weeks
Secondary Outcome Measure Information:
Title
A ratio of subject whose 25 OHD concentration is less than 9ng/mL
Description
A ratio of subject whose 25 OHD concentration is less than 9ng/mL after 16weeks
Time Frame
16 weeks
Title
Safety evaluation (AE, Lab test, Vital sign etc)
Time Frame
16weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female more than 40 years old in postmenopausal
Exclusion Criteria:
Subject who has a history of malignant cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moo-il Kang, MD, PhD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Study Chair
Facility Information:
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis
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