Osteoporosis
Conditions
Keywords
Risedronate,cholecalciferol,BMD,montly,weekly,compliance
Brief summary
The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal osteoporotic women(Phase IV)
Detailed description
The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) with Vitamin D in compliance, improvement of vitaminD and BMD in Korean postmenopausal osteoporotic women(Phase IV)
Interventions
DRUGRisedronate/Cholecalciferol combination(montly)
once a month
DRUGRisedronate/Cholecalciferol combination(weekly)
once a week
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female osteoporosis patients over 19years of age(with menopause). Definition of osteporosis * They had a BMD T-score -2.5 or less at mean Lumbar spine(L1\ L4), Femoral neck or total. Or evidence of at least one vertebral fracture. Definition of menopause(can be one of three condition) * For 12months spontaneous amenorrhea * For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40 mlIU/mL and over * 6weeks after bilateral ovariectomy whether hysterectomy of not 2. Patients who can be treated with oral bisphosphonate drugs 3. Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry) 4. Patients who made a voluntary agreement after explanation of this study 5. Patients who participated in clinical trial(HL\_RSNP\_401) must have taken the Risenexplus and finish the study for 12 months.
Exclusion criteria
1. Patients with esophagus disorder. 2. Patients administered with osteoprosis therapy(except calcium,Vit.D medication) within previous 3 months 3. Patients with serum calcium concentrations 8.0mg/dL under. 4. Patients with severe nephropathy(serum creatinine\> doulble of normal level 5. Patients with unable to sit upright or stand 30minutes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The propotion of patients with 25(Oh)D level <20mg/ml of 12 months | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of Bone Mineral Density(BMD) value | 1year | The change of Bone Mineral Density(BMD) value\[Time frame: 1 year\] The change of PTH(Parathyroid hormone value) \[Time frame:6months,1 year\] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups) |
| The change of PTH(Parathyroid hormone value) | 6months,1 year | The change of Bone Mineral Density(BMD) value\[Time frame: 1 year\] The change of PTH(Parathyroid hormone value) \[Time frame:6months,1 year\] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups) |
| The change of Compliance - overall groups of Risenex plus vs Risenex M | 1year | The change of Bone Mineral Density(BMD) value\[Time frame: 1 year\] The change of PTH(Parathyroid hormone value) \[Time frame:6months,1 year\] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups |
| The change of 25(Oh)D level in patients. | 6months,1year | — |
Countries
South Korea
Outcome results
None listed