Status:
COMPLETED
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
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Osteoporosis
Eligibility:
FEMALE
19+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2016
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT01904110
Start Date
December 1 2012
End Date
March 31 2016
Last Update
August 29 2018
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea