A Phase 3 interventional study of Test group and Reference group in Postmenopausal Women With Osteoporosis, sponsored by Alvogen Korea. Completed at 1 site in Korea, Republic of. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-11-01.
Sponsored by Alvogen Korea · Phase 3, Interventional, and Treatment
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 201 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Alvogen Korea is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Test group
Drug: Reference group
Once a month, administration of DP-R206 \& placebo for 16 weeks
Also known as: DP-R206 (Test drug), <Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU>
Once a month, administration of Bonviva \& placebo for 16 weeks
Also known as: Bonviva®, (Ibandronate 150mg)
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
Time frame: 16weeks
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
Time frame: 16 weeks
Safety evaluation (AE, Lab test, Vital sign etc)
Time frame: 16weeks
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Alvogen Korea