Post-menopausal Women Osteoporosis(Phase III)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis

Detailed Description
-----------------
The purpose of this study is to evaluate the efficacy and the safety of Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.

Official Title
-----------------
For 4 Months, the Multi Center, Double Blinded, Randomized, Active Controlled, Comparative Clinical Study to Assess the Efficacy and the Safety to Improvement Effect of Vit.D of Risenex Plus M Tablet in Patients With In Post-menopausal Women Osteoporosis

Conditions
-----------------
Postmenopausal Women Osteoporosis

Intervention / Treatment
-----------------
* Drug: risedronate combine
* Drug: Risedronate
* Drug: Placebo(for Risedronate)
* Drug: Placebo(for risedronate combine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women osteoporosis patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral density T-score of < -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or a T-score of < -1.0 with radiologic evidence of at least one vertebral fracture. Menopause was defined as no natural menses for at least 1 year and a serum FSH level > 40 IU/L, with a reported hysterectomy low levels of 25(OH)D > 9 ng/mL patients who give written consent of agreement to voluntarily participate in the clinical study patients who can read and understand written instructions Exclusion Criteria: patients who had contraindications to oral bisphosphonates, such as esophageal strictures ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL low levels of 25(OH)D (less than 9 ng/mL). Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period was needed, depending on the duration of treatment. Two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin D users of > 200 IU. drug administration after diagnosing as alcoholic or psychical disease patients whom the investigators judge as improper to participate in this clinical trial 7)13.patients who have experience to participate in other clinical trial within 30 days prior to study participation
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risendronate and Cholecalciferol combination<br>risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month. | Drug: risedronate combine<br> <br> * Other names: - Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined);Drug: Placebo(for Risedronate)<br> <br> * Other names: once a month;|
| Active Comparator: Risedronate<br>risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month. | Drug: Risedronate<br> <br> * Other names: Other name : Actonel(Risedronate 150mg);Drug: Placebo(for risedronate combine)<br> <br> * Other names: once a month;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks. |  | 16 weeks form first drug adminstration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers. | Secondary end point is : proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks change of 25(OH)D level change of BSAP change of CTX change of Ca change of phosphorous change of PTH change of 8-foot walking test, Sit-To-Stand test | 16 weeks form first drug administration. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis