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Trial record 25 of 844 for:    osteoporosis AND (woman OR women OR female)

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

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ClinicalTrials.gov Identifier: NCT01581320
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Alvogen Korea

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Women With Osteoporosis Drug: Test group Drug: Reference group Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
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
Study Start Date : December 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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 :
  1. 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

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


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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

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

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

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