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The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis

NCT ID: NCT02306187

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

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2024-12-31

Brief Summary

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In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment. However, the bone turnover markers or the bone mineral density (BMD) are not improved in some osteoporotic patients even though they have taken BPs and alfacalcidol more than several years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead of BPs and Alfacalcitol.

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Detailed Description

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Alfacalcitol and Eldecalcitol are the similar vitamin D drugs. However, Eldecalcitol is an improved vitamin D drug than Alfacalcitol. Therefore, we investigate the effectiveness of Eldecalcitol in this study.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-Alfacaocidol

Ahead of Eldecalcitol treatment, this group has not taken Alfacaocidol before. Eldecalcitol: the commercial name is Edirol We prescribe Edirol 0.5 or 0.75ug per day into each patient.

Group Type EXPERIMENTAL

Edirol

Intervention Type DRUG

Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.

Alfacalcidol

Ahead of Eldecalcitol treatment, this group has taken Alfacaocidol before. Eldecalcitol: the commercial name is Edirol We prescribe Edirol 0.5 or 0.75ug per day into each patient.

Group Type EXPERIMENTAL

Edirol

Intervention Type DRUG

Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.

Interventions

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Edirol

Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.

Intervention Type DRUG

Other Intervention Names

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Eldecalcitol

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Osteoporosis
* Must be able to swallow tablets

Exclusion Criteria

* N/A
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shinshu University

OTHER

Sponsor Role lead

Responsible Party

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Yukio Nakamura

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yukio Nakamura, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shinshu University School of Medicine

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

[email protected]
+81-263-37-2659

Facility Contacts

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Yukio Nakamura, MD, PhD

Role: primary

[email protected]
+81-263-37-2659

Other Identifiers

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BP-ED study 2014

Identifier Type: -

Identifier Source: org_study_id

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