Back to resultsExamination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
Primary Purpose
Osteoporosis
Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
"Teriparatide", "Forteo® or Teribon"
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Osteoporotic patients who want to take teriparatide and denosumab
Exclusion Criteria:
- Patients who are allergic to teriparatide or denosumab Patients who are pregnant or breast-feedin
Sites / Locations
- Yukio NakamuraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
TPTD 6M
TPTD 6-12M
TPTD 12-24M
Arm Description
Outcomes
Primary Outcome Measures
Bone mineral density
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03702140
Brief Title
Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
Official Title
Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
October 8, 2023 (Anticipated)
Study Completion Date
October 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
5. Study Description
Brief Summary
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients:
The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months.
The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months.
The administration period of teriparatide is more than 12 months and thereafter, denosumab for 24 months.
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
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TPTD 6M
Arm Type
Active Comparator
Arm Title
TPTD 6-12M
Arm Type
Active Comparator
Arm Title
TPTD 12-24M
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
"Teriparatide", "Forteo® or Teribon"
Intervention Description
To examine the effects of terimaratide less than 6 months 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
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Osteoporotic patients who want to take teriparatide and denosumab
Exclusion Criteria:
Patients who are allergic to teriparatide or denosumab Patients who are pregnant or breast-feedin
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
Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
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