To Evaluate the Efficacy and the Safety of Monthly Versus Weekly Oral Risedronate With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women

Study Overview
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Brief Summary
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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)

Detailed Description
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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)

Official Title
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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)

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Risedronate/Cholecalciferol combination(montly)
* Drug: Risedronate/Cholecalciferol combination(weekly)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female osteoporosis patients over 19years of age(with menopause). Definition of osteporosis They had a BMD T-score -2.5 or less at mean Lumbar spine(L1 L4), Femoral neck or total. Or evidence of at least one vertebral fracture. Definition of menopause(can be one of three condition) For 12months spontaneous amenorrhea For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40 mlIU/mL and over 6weeks after bilateral ovariectomy whether hysterectomy of not Patients who can be treated with oral bisphosphonate drugs Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry) Patients who made a voluntary agreement after explanation of this study Patients who participated in clinical trial(HL_RSNP_401) must have taken the Risenexplus and finish the study for 12 months. Exclusion Criteria: Patients with esophagus disorder. Patients administered with osteoprosis therapy(except calcium,Vit.D medication) within previous 3 months Patients with serum calcium concentrations 8.0mg/dL under. Patients with severe nephropathy(serum creatinine> doulble of normal level Patients with unable to sit upright or stand 30minutes.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risenex M<br>Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months | Drug: Risedronate/Cholecalciferol combination(montly)<br>* once a month<br>* Other names: Risenex M;|
| Active Comparator: Risenex Plus<br>Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months | Drug: Risedronate/Cholecalciferol combination(montly)<br>* once a month<br>* Other names: Risenex M;Drug: Risedronate/Cholecalciferol combination(weekly)<br>* once a week<br>* Other names: Risenex Plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The propotion of patients with 25(Oh)D level <20mg/ml of 12 months |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Bone Mineral Density(BMD) value | 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) | 1year | 
| The change of PTH(Parathyroid hormone value) | 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) | 6months,1 year | 
| The change of Compliance - overall groups of Risenex plus vs Risenex M | 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 | 1year | 
| The change of 25(Oh)D level in patients. |  | 6months,1year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risedronate,cholecalciferol,BMD,montly,weekly,compliance