Efficacy of Zoledronic Acid in Osteoporosis

Osteoporosis Clinical Trial

Official title:

Examination of Bone Metabolism and Bone Mineral Density by Zoledronic Acid in Primary and Secondary Osteoporosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03183557
• Other study ID #: Zol2017
• Status: Recruiting
• Phase: Phase 2
• Start date: October 12, 2017
• Est. completion date: June 8, 2025

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 8, 2025
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• "Zoledronic acid", "Reclast®"
To examine the efficacy of zoledronic acid in osteoporosis
• "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"
To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis

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	Bone mineral density		Change from Baseline Values at 1 year