Samsung Medical Center
Seoul, South Korea
NCT Number: NCT01904110
The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal osteoporotic women(Phase IV)
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Notify Me19 year and older
Female
Interventional
Phase 4
Seoul, South Korea
The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) with Vitamin D in compliance, improvement of vitaminD and BMD in Korean postmenopausal osteoporotic women(Phase IV)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Definition of osteporosis
Definition of menopause(can be one of three condition)
Exclusion criteria
once a month
Other names: Risenex M
once a week
Other names: Risenex Plus
Time frame: 1 year
Time frame: 1year
The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups)
Time frame: 6months,1 year
The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups)
Time frame: 1year
The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups
Time frame: 6months,1year
Hanlim Pharm. Co., Ltd.
Industry
For 12months, the Multi Center, Randomized, Open-label Comparative Clinical Study to Evaluate the Efficacy and the Safety of Monthly(RisenexM Group) Versus Weekly Oral Risedronate(Risenexsplus Group) With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women(Phase IV)
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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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