NCT03702140

Brief Summary

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients:

  1. 1.The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months.
  2. 2.The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months.
  3. 3.The administration period of teriparatide is more than 12 months and thereafter, denosumab for 24 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2025

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

October 8, 2018

Last Update Submit

September 20, 2021

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    Change from Baseline Values at 1 year

Study Arms (3)

TPTD 6M

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

TPTD 6-12M

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

TPTD 12-24M

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

Interventions

"Teriparatide", "Forteo® or Teribon"DRUG

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

TPTD 12-24MTPTD 6-12MTPTD 6M

Eligibility Criteria

Age20 Years - 120 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale patients are separately analyzed
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoporotic patients who want to take teriparatide and denosumab

You may not qualify if:

  • Patients who are allergic to teriparatide or denosumab Patients who are pregnant or breast-feedin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yukio Nakamura

Matsumoto, Nagano, 3908621, Japan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at Shinshu University School of Medicine

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 2018

Study Start

October 9, 2018

Primary Completion

October 8, 2023

Study Completion

October 8, 2025

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)