Postmenopausal Women Osteoporosis
Conditions
Keywords
Osteoporosis
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.
Interventions
DRUGPlacebo(for Risedronate)
DRUGPlacebo(for risedronate combine)
DRUGrisedronate combine
DRUGRisedronate
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks. | 16 weeks form first drug adminstration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers. | 16 weeks form first drug administration. | Secondary end point is : 1. proportion of patients with 25(OH)D level \< 9 ng/mL at 16 weeks 2. change of 25(OH)D level 3. change of BSAP 4. change of CTX 5. change of Ca 6. change of phosphorous 7. change of PTH 8. change of 8-foot walking test, Sit-To-Stand test |
Countries
South Korea
Outcome results
None listed