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

Postmenopausal Women With Osteoporosis Clinical Trial

— DIOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581320
• Other study ID #: DP-CTR206-03
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2012
• Last updated: October 31, 2016
• Start date: December 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2012
• Source: Alvogen Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Female more than 40 years old in postmenopausal

Exclusion Criteria:

• Subject who has a history of malignant cancer

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Postmenopausal Women With Osteoporosis

Intervention

Drug:
• Test group
Once a month, administration of DP-R206 & placebo for 16 weeks
• Reference group
Once a month, administration of Bonviva & placebo for 16 weeks

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Alvogen Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A ratio of subject whose 25 OHD concentration is less than 15ng/mL	A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks	16weeks	No
Secondary	A ratio of subject whose 25 OHD concentration is less than 9ng/mL	A ratio of subject whose 25 OHD concentration is less than 9ng/mL after 16weeks	16 weeks	No
Secondary	Safety evaluation (AE, Lab test, Vital sign etc)		16weeks	Yes