Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

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 Risedronate, cholecalciferol combination tablet in patients with Osteoporosis.

Detailed Description
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The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.

Official Title
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For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Risedronate/Cholecalciferol combination
* Drug: Risedronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male osteoporosis patients over 19 years of age Female osteoporosis patients with menopause Definition of osteoporosis 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 40mlU/mL and over 6weeks after bilateral ovariectomy whether hysterectomy or not. Exclusion Criteria: Patients with esophagus disorder (i.e:esophagostenosis) Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months Patients with serum calcium concentrations 8.0mg under Patients with severe nephropathy (CCr 30mL/min less) Patients with unable to sit upright or stand for 30minutes

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

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: Risendronate/Cholecalciferol combination<br>Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months | Drug: Risedronate/Cholecalciferol combination<br>* Risendronate/Cholecalciferol combination once a week<br>* Other names: RisenexPlus tablet;|
| Active Comparator: Risedronate<br>Sedron tablet: one tablet once a week for 12months | Drug: Risedronate<br>* Risedronate once a week<br>* Other names: Sedron 35mg tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change of Bone Mineral Density (BMD) Value | Higher Bone Mineral Density(BMD) value mean a better outcome. | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change of 25OHD(25-hydroxyvitamin D) | range of 25OHD: 4.80 52.80 Higher 25OHD scores mean a better outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed. | baseline, 6months, 12months | 
| PTH(Parathyroid Hormone Value) | range of PTH: 13 54 Higher PTH scores mean a worse outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed. | baseline, 6months, 12months | 

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