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

NCT03702140 — Phase 2, Unknown, 90 participants, Shinshu University

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RegistryNCT03702140
StatusUnknown
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment90 (Estimated)
SponsorShinshu University (Other)
ConditionsOsteoporosis
Interventions"Teriparatide", "Forteo® or Teribon" (Drug)
Datesstart 2018-10-09, primary completion 2023-10-08 (estimated), completion 2025-10-08 (estimated), first posted 2018-10-10, last updated 2021-09-21
Locations1 site in Japan

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
TPTD 6MActive comparatorDrug: "Teriparatide", "Forteo® or Teribon"
TPTD 6-12MActive comparatorDrug: "Teriparatide", "Forteo® or Teribon"
TPTD 12-24MActive comparatorDrug: "Teriparatide", "Forteo® or Teribon"
  • "Teriparatide", "Forteo® or Teribon" (Drug): To examine the effects of terimaratide less than 6 months in osteoporosis

+Outcome measures

Primary outcomes

  • Bone mineral density [Change from Baseline Values at 1 year]

+Eligibility

Sex: All, ages: 20 Years to 120 Years

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

+Locations (1)

FacilityCityCountryStatus
Yukio NakamuraMatsumoto, NaganoJapanRecruiting

My Notes