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

NCT ID: NCT03702140

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-09

Study Completion Date

2025-10-08

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TPTD 6M

Group Type ACTIVE_COMPARATOR

"Teriparatide", "Forteo® or Teribon"

Intervention Type DRUG

To examine the effects of terimaratide less than 6 months in osteoporosis

TPTD 6-12M

Group Type ACTIVE_COMPARATOR

"Teriparatide", "Forteo® or Teribon"

Intervention Type DRUG

To examine the effects of terimaratide less than 6 months in osteoporosis

TPTD 12-24M

Group Type ACTIVE_COMPARATOR

"Teriparatide", "Forteo® or Teribon"

Intervention Type DRUG

To examine the effects of terimaratide less than 6 months in osteoporosis

Interventions

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"Teriparatide", "Forteo® or Teribon"

To examine the effects of terimaratide less than 6 months in osteoporosis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shinshu University

OTHER

Sponsor Role lead

Responsible Party

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Yukio Nakamura

Lecturer at Shinshu University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yukio Nakamura

Matsumoto, Nagano, Japan

Site Status RECRUITING

Countries

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Japan

Facility Contacts

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Yukio Nakamura, MD, PhD

Role: primary

+81-263-37-2659

Other Identifiers

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PTH-DMAb 2018

Identifier Type: -

Identifier Source: org_study_id

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