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

Phase 2

Recruiting

• Conditions: Osteoporosis
• Interventions: Drug: "Teriparatide", "Forteo® or Teribon"

• Registration Number: NCT03702140
• Lead Sponsor: Shinshu University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-08
• Study Start: 2018-10-09
• Study First Posted: 2018-10-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21
• Primary Completion: 2023-10-08
• Study Completion: 2025-10-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPTD 6M	"Teriparatide", "Forteo® or Teribon"	-
TPTD 6-12M	"Teriparatide", "Forteo® or Teribon"	-
TPTD 12-24M	"Teriparatide", "Forteo® or Teribon"	-

Primary Outcome Measures

Name	Time	Method
Bone mineral density	Change from Baseline Values at 1 year

Trial Locations

Locations (1)

Yukio Nakamura; 🇯🇵 Matsumoto, Nagano, Japan