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

This study is currently recruiting participants.
Verified April 2012 by DreamPharma
Sponsor:
Information provided by (Responsible Party):
DreamPharma
ClinicalTrials.gov Identifier:
NCT01581320
First received: February 26, 2012
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by DreamPharma:

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 ]

Estimated Enrollment: 204
Study Start Date: January 2012
Estimated Primary Completion Date: July 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581320

Contacts
Contact: Jae-Won Lee, PhD 82-2-729-4125 jwleeg@hanwha.co.kr
Contact: Hye-Yeon Jung, B.S. 82-2-729-4112 yeoni518@hanwha.co.kr

Locations
Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Sunhee Ko, MD     82-2-2258-6006     kshpeter@catholic.ac.kr    
Sponsors and Collaborators
DreamPharma
Investigators
Study Chair: Moo-il Kang, MD, PhD The Catholic University of Korea Seoul St.Mary's Hospital
  More Information

No publications provided

Responsible Party: DreamPharma
ClinicalTrials.gov Identifier: NCT01581320     History of Changes
Other Study ID Numbers: DP-CTR206-03
Study First Received: February 26, 2012
Last Updated: April 18, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on June 17, 2013