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

Shinshu University

Status and phase: Enrolling; Phase 2

Conditions: Osteoporosis

Treatments: Drug: "Teriparatide", "Forteo® or Teribon"

Study type: Interventional

Funder types: Other

Identifiers

NCT03702140

PTH-DMAb 2018

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 3 patient groups

TPTD 6M

Active Comparator group

Treatment:

Drug: "Teriparatide", "Forteo® or Teribon"

TPTD 6-12M

Active Comparator group

Treatment:

Drug: "Teriparatide", "Forteo® or Teribon"

TPTD 12-24M

Active Comparator group

Treatment:

Drug: "Teriparatide", "Forteo® or Teribon"