Efficacy of Zoledronic Acid in Osteoporosis | NCT03183557

Studies
Efficacy of Zoledronic Acid in Osteoporosis

NCT03183557

Sponsor

Shinshu University

Status

Unknown status

Last Update Posted

Sep 21, 2021Actual

Enrollment

100Estimated

Phase

Phase 2

Conditions

Osteoporosis

Interventions

"Zoledronic acid", "Reclast®"
"Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"

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 12, 2017Actual

Primary Completion Date

Dec 8, 2022Estimated

Completion Date

Jun 8, 2025Estimated

First Submitted Date

Jun 5, 2017

First Submission Date that Met QC Criteria

Jun 9, 2017

First Posted Date

Jun 12, 2017Actual

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, Associate professor at Shinshu University, Shinshu UniversityPrincipal Investigator

Lead Sponsor

Shinshu UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ZA alone	Active Comparator		Drug: "Zoledronic acid", "Reclast®"
ZA plus VD	Active Comparator		Drug: "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"

Interventions

Name	Type	Description	Arm Group Labels	Other Names
"Zoledronic acid", "Reclast®"	Drug	To examine the efficacy of zoledronic acid in osteoporosis	ZA alone

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 zoledronic acid

Exclusion Criteria:

Patients who are allergic to zoledronic acid or vitamin D
Patients who are pregnant or breast-feeding
Patients who have not taken zoledronic acid for the last 2 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Male patients are separately analyzed

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yukio Nakamura, MD, PhD	Contact	+81-263-37-2659		yxn14@aol.jp

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
D000077211	Zoledronic Acid
C008088	alfacalcidol

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided