Back to resultsChanges of Bone Turnover Markers and Bone Mineral Density After Osteoporosis Treatment
Primary Purpose
Osteoporosis
Status
Recruiting
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Ibandronic acid, vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Osteoporosis
Exclusion Criteria:
- Kidney, parathyroid, congenital bone metabolic disease
Sites / Locations
- Showa Inan General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Osteoporosis
Arm Description
Outcomes
Primary Outcome Measures
Changes of bone mineral density
To examine the changes of bone mineral density for the purpose of the effectiveness of the drug
Secondary Outcome Measures
Improvement of bone turnover markers
To examine the changes of bone turnover markers for the purpose of the effectiveness of the drug
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02156999
Brief Title
Changes of Bone Turnover Markers and Bone Mineral Density After Osteoporosis Treatment
Official Title
Changes of Bone Turnover Markers and Bone Mineral Density After Treatment in Osteoporotic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 2014 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shinshu University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To examine the changes of bone mineral density and bone turnover markers after Bonviva treatment in osteoporotic patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osteoporosis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ibandronic acid, vitamin D
Primary Outcome Measure Information:
Title
Changes of bone mineral density
Description
To examine the changes of bone mineral density for the purpose of the effectiveness of the drug
Time Frame
every 4-6 months
Secondary Outcome Measure Information:
Title
Improvement of bone turnover markers
Description
To examine the changes of bone turnover markers for the purpose of the effectiveness of the drug
Time Frame
Every 3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Osteoporosis
Exclusion Criteria:
Kidney, parathyroid, congenital bone metabolic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
Facility Information:
Facility Name
Showa Inan General Hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4117
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
12. IPD Sharing Statement
Learn more about this trial
Changes of Bone Turnover Markers and Bone Mineral Density After Osteoporosis Treatment
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