Status:
COMPLETED
Post-menopausal Women Osteoporosis(Phase III)
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Postmenopausal Women Osteoporosis
Eligibility:
FEMALE
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01806792
Start Date
November 1 2009
End Date
March 1 2011
Last Update
March 7 2013
Active Locations (1)
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1
Chung-ang university hospital
Seoul, South Korea, 156-755