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:

  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.

Study Overview

Status

Recruiting

Conditions

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.

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

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.

Clinical Trials on Osteoporosis

Clinical Trials on "Teriparatide", "Forteo® or Teribon"

3
Subscribe