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NCT03702140 Clinical Trial

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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03702140
Other study ID # PTH-DMAb 2018
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 9, 2018
Est. completion date October 8, 2025

Study information
Verified date September 2021
Source Shinshu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date October 8, 2025
Est. primary completion date October 8, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• "Teriparatide", "Forteo® or Teribon"
To examine the effects of terimaratide less than 6 months in osteoporosis

Locations
Country Name City State
Japan Yukio Nakamura Matsumoto Nagano

Sponsors (1)
Lead Sponsor Collaborator
Shinshu University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bone mineral density Change from Baseline Values at 1 year
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