Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alvogen Korea
ClinicalTrials.gov Identifier:
NCT01581320
First received: February 26, 2012
Last updated: October 31, 2016
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 26, 2012
Last Updated: October 31, 2016
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on December 09, 2016