Examination How the Administration Period of Teriparatide... | NCT03702140

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

NCT03702140

Sponsor

Shinshu University

Status

Unknown status

Last Update Posted

Sep 21, 2021Actual

Enrollment

90Estimated

Phase

Phase 2

Conditions

Osteoporosis

Interventions

"Teriparatide", "Forteo® or Teribon"

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 9, 2018Actual

Primary Completion Date

Oct 8, 2023Estimated

Completion Date

Oct 8, 2025Estimated

First Submitted Date

Oct 8, 2018

First Submission Date that Met QC Criteria

Oct 8, 2018

First Posted Date

Oct 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2021

Last Update Posted Date

Sep 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yukio Nakamura, Lecturer at Shinshu University School of Medicine, Shinshu UniversityPrincipal Investigator

Lead Sponsor

Shinshu UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
"Teriparatide", "Forteo® or Teribon"	Drug	To examine the effects of terimaratide less than 6 months in osteoporosis	TPTD 12-24M TPTD 6-12M TPTD 6M

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone mineral density		Change from Baseline Values at 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Male patients are separately analyzed

Minimum Age

20 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yukio Nakamura	Recruiting	Matsumoto	Nagano	3908621	Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019379	Teriparatide

Ancestor Terms

ID	Term
D010281	Parathyroid Hormone
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided