Back to resultsEfficacy of Zoledronic Acid in Osteoporosis
Primary Purpose
Osteoporosis
Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
"Zoledronic acid", "Reclast®"
"Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Osteoporotic patients who want to take zoledronic acid
Exclusion Criteria:
- Patients who are allergic to zoledronic acid or vitamin D
- Patients who are pregnant or breast-feeding
- Patients who have not taken zoledronic acid for the last 2 years
Sites / Locations
- Yukio NakamuraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ZA alone
ZA plus VD
Arm Description
Outcomes
Primary Outcome Measures
Bone mineral density
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03183557
Brief Title
Efficacy of Zoledronic Acid in Osteoporosis
Official Title
Examination of Bone Metabolism and Bone Mineral Density by Zoledronic Acid in Primary and Secondary Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
December 8, 2022 (Anticipated)
Study Completion Date
June 8, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shinshu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.
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 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ZA alone
Arm Type
Active Comparator
Arm Title
ZA plus VD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
"Zoledronic acid", "Reclast®"
Intervention Description
To examine the efficacy of zoledronic acid in osteoporosis
Intervention Type
Drug
Intervention Name(s)
"Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"
Intervention Description
To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis
Primary Outcome Measure Information:
Title
Bone mineral density
Time Frame
Change from Baseline Values at 1 year
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Male patients are separately analyzed
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Osteoporotic patients who want to take zoledronic acid
Exclusion Criteria:
Patients who are allergic to zoledronic acid or vitamin D
Patients who are pregnant or breast-feeding
Patients who have not taken zoledronic acid for the last 2 years
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
Yukio Nakamura
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
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
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Zoledronic Acid in Osteoporosis
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