Back to resultsEfficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Risedronate/Cholecalciferol combination
Risedronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring Risedronate, cholecalciferol, BMD
Eligibility Criteria
Inclusion Criteria:
- Male osteoporosis patients over 19 years of age
Female osteoporosis patients with menopause
Definition of osteoporosis
- 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 40mlU/mL and over
- 6weeks after bilateral ovariectomy whether hysterectomy or not.
Exclusion Criteria:
- Patients with esophagus disorder (i.e:esophagostenosis)
- Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
- Patients with serum calcium concentrations 8.0mg under
- Patients with severe nephropathy (CCr 30mL/min less)
- Patients with unable to sit upright or stand for 30minutes
Sites / Locations
- Chung-ang university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Risendronate/Cholecalciferol combination
Risedronate
Arm Description
Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months
Sedron tablet: one tablet once a week for 12months
Outcomes
Primary Outcome Measures
The Change of Bone Mineral Density (BMD) Value
Higher Bone Mineral Density(BMD) value mean a better outcome.
Secondary Outcome Measures
The Change of 25OHD(25-hydroxyvitamin D)
range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
PTH(Parathyroid Hormone Value)
range of PTH: 13~54 Higher PTH scores mean a worse outcome.
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01675297
Brief Title
Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis
Official Title
For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 4, 2011 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 15, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Risedronate, cholecalciferol, BMD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1053 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risendronate/Cholecalciferol combination
Arm Type
Experimental
Arm Description
Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months
Arm Title
Risedronate
Arm Type
Active Comparator
Arm Description
Sedron tablet: one tablet once a week for 12months
Intervention Type
Drug
Intervention Name(s)
Risedronate/Cholecalciferol combination
Other Intervention Name(s)
RisenexPlus tablet
Intervention Description
Risendronate/Cholecalciferol combination once a week
Intervention Type
Drug
Intervention Name(s)
Risedronate
Other Intervention Name(s)
Sedron 35mg tablet
Intervention Description
Risedronate once a week
Primary Outcome Measure Information:
Title
The Change of Bone Mineral Density (BMD) Value
Description
Higher Bone Mineral Density(BMD) value mean a better outcome.
Time Frame
baseline and 12 months
Secondary Outcome Measure Information:
Title
The Change of 25OHD(25-hydroxyvitamin D)
Description
range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
Time Frame
baseline, 6months, 12months
Title
PTH(Parathyroid Hormone Value)
Description
range of PTH: 13~54 Higher PTH scores mean a worse outcome.
If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
Time Frame
baseline, 6months, 12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male osteoporosis patients over 19 years of age
Female osteoporosis patients with menopause
Definition of osteoporosis
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 40mlU/mL and over
6weeks after bilateral ovariectomy whether hysterectomy or not.
Exclusion Criteria:
Patients with esophagus disorder (i.e:esophagostenosis)
Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
Patients with serum calcium concentrations 8.0mg under
Patients with severe nephropathy (CCr 30mL/min less)
Patients with unable to sit upright or stand for 30minutes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung-Moo Park, MD
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-ang university hospital
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis
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