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

Shinshu University

Status and phase: Enrolling; Phase 1

Conditions: Osteoporosis

Treatments: Drug: Edirol

Study type: Interventional

Funder types: Other

Identifiers

NCT02306187

BP-ED study 2014

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• N/A

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Non-Alfacaocidol

Experimental group

Description:

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.

Treatment:

Drug: Edirol

Alfacalcidol

Experimental group

Description:

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.

Treatment:

Drug: Edirol