Efficacy of Zoledronic Acid in Osteoporosis

NCT ID: NCT03183557

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-12

Study Completion Date

2025-06-08

Brief Summary

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

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ZA alone

Group Type ACTIVE_COMPARATOR

"Zoledronic acid", "Reclast®"

Intervention Type DRUG

To examine the efficacy of zoledronic acid in osteoporosis

ZA plus VD

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis

Interventions

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"Zoledronic acid", "Reclast®"

To examine the efficacy of zoledronic acid in osteoporosis

Intervention Type DRUG

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

To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shinshu University

OTHER

Sponsor Role lead

Responsible Party

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Yukio Nakamura

Associate professor at Shinshu University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yukio Nakamura

Matsumoto, Nagano, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yukio Nakamura, MD, PhD

Role: CONTACT

+81-263-37-2659

Facility Contacts

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Yukio Nakamura, MD, PhD

Role: primary

+81-263-37-2659

Other Identifiers

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Zol2017

Identifier Type: -

Identifier Source: org_study_id

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