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

Osteoporosis Clinical Trial

Official title:

The Effectiveness of Eldecalcitol in the Osteoporotic Patients Who Are Bisphosphonate Non-responders After Long-term Bisphosphonate Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306187
• Other study ID #: BP-ED study 2014
• Status: Recruiting
• Phase: Phase 1
• Start date: December 2014
• Est. completion date: December 2024

Study information

• Verified date: September 2021
• Source: Shinshu University
• Contact: Yukio Nakamura, MD, PhD
• Phone: +81-263-37-2659
• Email: yxn14[@]aol.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Japan	Yukio Nakamura	Matsumoto	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Shinshu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with bone turnover markers as a Measure of bone quality	Bone formation and bone absorption markers will be evaluated at each time point	At 4 months after the initial treatment
Primary	Number of Participants with bone turnover markers as a Measure of bone quality	Bone formation and bone absorption markers will be evaluated at each time point	At 1 year after the initial treatment
Secondary	Number of Participants with bone mineral density as a Measure of bone quality	Bone mineral density will be evaluated at each time point	At 4 months after the initial treatment
Secondary	Number of Participants with bone mineral density as a Measure of bone quality	Bone mineral density will be evaluated at each time point	At 1 year after the initial treatment