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
NCT ID: NCT01904110
Last Updated: 2018-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
196 participants
INTERVENTIONAL
2012-12-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Risenex M
Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months
Risedronate/Cholecalciferol combination(montly)
once a month
Risenex Plus
Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months
Risedronate/Cholecalciferol combination(montly)
once a month
Risedronate/Cholecalciferol combination(weekly)
once a week
Interventions
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Risedronate/Cholecalciferol combination(montly)
once a month
Risedronate/Cholecalciferol combination(weekly)
once a week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
FEMALE
No
Sponsors
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Hanlim Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Youngki Min, MD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center Seoul
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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HL_RSNM_401
Identifier Type: -
Identifier Source: org_study_id
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