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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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Risedronate/Cholecalciferol combination(montly)
Risedronate/Cholecalciferol combination(weekly)
Sponsored by
Hanlim Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Risedronate,cholecalciferol,BMD,montly,weekly,compliance

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Risenex M

Risenex Plus

Arm Description

Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months

Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months

Outcomes

Primary Outcome Measures

The propotion of patients with 25(Oh)D level <20mg/ml of 12 months

Secondary Outcome Measures

The change of Bone Mineral Density(BMD) value
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)
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
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.

Full Information

First Posted
July 16, 2013
Last Updated
August 28, 2018
Sponsor
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01904110
Brief Title
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
Official Title
For 12months, the Multi Center, Randomized, Open-label Comparative Clinical Study to Evaluate the Efficacy and the Safety of Monthly(RisenexM Group) Versus Weekly Oral Risedronate(Risenexsplus Group) With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women(Phase IV)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 29, 2014 (Actual)
Study Completion Date
March 31, 2016 (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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Risedronate,cholecalciferol,BMD,montly,weekly,compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Risenex M
Arm Type
Experimental
Arm Description
Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months
Arm Title
Risenex Plus
Arm Type
Active Comparator
Arm Description
Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months
Intervention Type
Drug
Intervention Name(s)
Risedronate/Cholecalciferol combination(montly)
Other Intervention Name(s)
Risenex M
Intervention Description
once a month
Intervention Type
Drug
Intervention Name(s)
Risedronate/Cholecalciferol combination(weekly)
Other Intervention Name(s)
Risenex Plus
Intervention Description
once a week
Primary Outcome Measure Information:
Title
The propotion of patients with 25(Oh)D level <20mg/ml of 12 months
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The change of Bone Mineral Density(BMD) value
Description
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)
Time Frame
1year
Title
The change of PTH(Parathyroid hormone value)
Description
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)
Time Frame
6months,1 year
Title
The change of Compliance - overall groups of Risenex plus vs Risenex M
Description
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
Time Frame
1year
Title
The change of 25(Oh)D level in patients.
Time Frame
6months,1year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youngki Min, MD
Organizational Affiliation
Samsung Medical Center Seoul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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