Postmenopausal Women Osteoporosis Clinical Trial
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
| Verified date | March 2013 |
| Source | Hanlim Pharm. Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | March 2011 |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: 1. women osteoporosis 2. 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 3. low levels of 25(OH)D > 9 ng/mL 4. patients who give written consent of agreement to voluntarily participate in the clinical study 5. patients who can read and understand written instructions Exclusion Criteria: 1. patients who had contraindications to oral bisphosphonates, such as esophageal strictures 2. ALT, AST = 2×UNL and Serum Creatinine = 1.5×UNL 3. low levels of 25(OH)D (less than 9 ng/mL). 4. 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. 5. drug administration after diagnosing as alcoholic or psychical disease 6. 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Chung-ang university hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Hanlim Pharm. Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks. | 16 weeks form first drug adminstration. | No | |
| Secondary | 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. | No |