Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03702140
Recruitment Status : Recruiting
First Posted : October 10, 2018
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Yukio Nakamura, Shinshu University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients:

  1. The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months.
  2. The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months.
  3. The administration period of teriparatide is more than 12 months and thereafter, denosumab for 24 months.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: "Teriparatide", "Forteo® or Teribon" Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : October 8, 2023
Estimated Study Completion Date : October 8, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: TPTD 6M Drug: "Teriparatide", "Forteo® or Teribon"
To examine the effects of terimaratide less than 6 months in osteoporosis
Active Comparator: TPTD 6-12M Drug: "Teriparatide", "Forteo® or Teribon"
To examine the effects of terimaratide less than 6 months in osteoporosis
Active Comparator: TPTD 12-24M Drug: "Teriparatide", "Forteo® or Teribon"
To examine the effects of terimaratide less than 6 months in osteoporosis


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: Change from Baseline Values at 1 year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients are separately analyzed
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702140


Locations
Layout table for location information
Japan
Yukio Nakamura Recruiting
Matsumoto, Nagano, Japan, 3908621
Contact: Yukio Nakamura, MD, PhD    +81-263-37-2659    yxn14@aol.jp   
Principal Investigator: Yukio Nakamura, MD, PhD         
Sponsors and Collaborators
Shinshu University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yukio Nakamura, Lecturer at Shinshu University School of Medicine, Shinshu University
ClinicalTrials.gov Identifier: NCT03702140    
Other Study ID Numbers: PTH-DMAb 2018
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
 Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents