Postmenopausal Women With Osteoporosis
Conditions
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.
Interventions
DRUGTest group
Once a month, administration of DP-R206 & placebo for 16 weeks
DRUGReference group
Once a month, administration of Bonviva & placebo for 16 weeks
Sponsors
Alvogen Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female more than 40 years old in postmenopausal
Exclusion criteria
* Subject who has a history of malignant cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A ratio of subject whose 25 OHD concentration is less than 15ng/mL | 16weeks | A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A ratio of subject whose 25 OHD concentration is less than 9ng/mL | 16 weeks | A ratio of subject whose 25 OHD concentration is less than 9ng/mL after 16weeks |
| Safety evaluation (AE, Lab test, Vital sign etc) | 16weeks | — |
Countries
South Korea
Outcome results
None listed