Post-menopausal Women Osteoporosis(Phase III)

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Cholecalciferol; Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

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