NCT03183557

Brief Summary

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

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
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2017

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

June 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 12, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2025

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

5.2 years

First QC Date

June 5, 2017

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 (2)

ZA alone

ACTIVE COMPARATOR
Drug: "Zoledronic acid", "Reclast®"

ZA plus VD

ACTIVE COMPARATOR
Drug: "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"

Interventions

"Zoledronic acid", "Reclast®"DRUG

To examine the efficacy of zoledronic acid in osteoporosis

ZA alone
"Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"DRUG

To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis

ZA plus VD

Eligibility Criteria

Age20 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 zoledronic acid

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yukio Nakamura

Matsumoto, Nagano, 3908621, Japan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Zoledronic Acidalfacalcidol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Yukio Nakamura, MD, PhD

CONTACT

+81-263-37-2659yxn14@aol.jp

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
Associate professor at Shinshu University

Study Record Dates

First Submitted

June 5, 2017

First Posted

June 12, 2017

Study Start

October 12, 2017

Primary Completion

December 8, 2022

Study Completion

June 8, 2025

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)