- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03702140
Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
September 20, 2021 updated by: Yukio Nakamura, Shinshu University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nagano
-
Matsumoto, Nagano, Japan, 3908621
- Recruiting
- Yukio Nakamura
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 120 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: TPTD 6M
|
To examine the effects of terimaratide less than 6 months in osteoporosis
|
ACTIVE_COMPARATOR: TPTD 6-12M
|
To examine the effects of terimaratide less than 6 months in osteoporosis
|
ACTIVE_COMPARATOR: TPTD 12-24M
|
To examine the effects of terimaratide less than 6 months in osteoporosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bone mineral density
Time Frame: Change from Baseline Values at 1 year
|
Change from Baseline Values at 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 9, 2018
Primary Completion (ANTICIPATED)
October 8, 2023
Study Completion (ANTICIPATED)
October 8, 2025
Study Registration Dates
First Submitted
October 8, 2018
First Submitted That Met QC Criteria
October 8, 2018
First Posted (ACTUAL)
October 10, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 21, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTH-DMAb 2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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