To Evaluate the Efficacy and the Safety of Monthly Versus Weekly Oral Risedronate With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women
- Conditions
- Osteoporosis
- Interventions
- Drug: Risedronate/Cholecalciferol combination(montly)Drug: Risedronate/Cholecalciferol combination(weekly)
- Registration Number
- NCT01904110
- Lead Sponsor
- Hanlim Pharm. Co., Ltd.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 196
-
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
-
Patients who can be treated with oral bisphosphonate drugs
-
Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry)
-
Patients who made a voluntary agreement after explanation of this study
-
Patients who participated in clinical trial(HL_RSNP_401) must have taken the Risenexplus and finish the study for 12 months.
- Patients with esophagus disorder.
- Patients administered with osteoprosis therapy(except calcium,Vit.D medication) within previous 3 months
- Patients with serum calcium concentrations 8.0mg/dL under.
- Patients with severe nephropathy(serum creatinine> doulble of normal level
- Patients with unable to sit upright or stand 30minutes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risenex M Risedronate/Cholecalciferol combination(montly) Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months Risenex Plus Risedronate/Cholecalciferol combination(montly) Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months Risenex Plus Risedronate/Cholecalciferol combination(weekly) Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months
- Primary Outcome Measures
Name Time Method The propotion of patients with 25(Oh)D level <20mg/ml of 12 months 1 year
- Secondary Outcome Measures
Name Time Method 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 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)
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of