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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581320
First Posted: April 20, 2012
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alvogen Korea
  Purpose
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.

Condition Intervention Phase
Postmenopausal Women With Osteoporosis Drug: Test group Drug: Reference group Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alvogen Korea:

Primary Outcome Measures:
  • A ratio of subject whose 25 OHD concentration is less than 15ng/mL [ Time Frame: 16weeks ]
    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 [ Time Frame: 16 weeks ]
    A ratio of subject whose 25 OHD concentration is less than 9ng/mL after 16weeks

  • Safety evaluation (AE, Lab test, Vital sign etc) [ Time Frame: 16weeks ]

Enrollment: 201
Study Start Date: December 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DP-R206 Drug: Test group
Once a month, administration of DP-R206 & placebo for 16 weeks
Other Names:
  • DP-R206 (Test drug)
  • <Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU>
Active Comparator: Bonviva Drug: Reference group
Once a month, administration of Bonviva & placebo for 16 weeks
Other Names:
  • Bonviva®
  • (Ibandronate 150mg)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female more than 40 years old in postmenopausal

Exclusion Criteria:

  • Subject who has a history of malignant cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581320


Locations
Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Alvogen Korea
Investigators
Study Chair: Moo-il Kang, MD, PhD The Catholic University of Korea
  More Information

Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT01581320     History of Changes
Other Study ID Numbers: DP-CTR206-03
First Submitted: February 26, 2012
First Posted: April 20, 2012
Last Update Posted: November 1, 2016
Last Verified: April 2012

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Cholecalciferol
Ibandronic acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents