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Completed

NCT Number: NCT01581320

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

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.

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Key information

Conditions

Postmenopausal Women With Osteoporosis

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female more than 40 years old in postmenopausal

Exclusion criteria

  • Subject who has a history of malignant cancer

Treatment and study plan

Test group

Drug

Once a month, administration of DP-R206 & placebo for 16 weeks

Other names: DP-R206 (Test drug), <Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU>

Reference group

Drug

Once a month, administration of Bonviva & placebo for 16 weeks

Other names: Bonviva®, (Ibandronate 150mg)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alvogen Korea

Industry

Registry information

Official study 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

Acronym: DIOS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2012
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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