Efficacy of Zoledronic Acid in Osteoporosis

Phase 2

Recruiting

• Conditions: Osteoporosis
• Interventions: Drug: "Zoledronic acid", "Reclast®"; Drug: "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"

• Registration Number: NCT03183557
• Lead Sponsor: Shinshu University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-12
• Study Start: 2017-10-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21
• Primary Completion: 2022-12-08
• Study Completion: 2025-06-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZA alone	"Zoledronic acid", "Reclast®"	-
ZA plus VD	"Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"	-

Primary Outcome Measures

Name	Time	Method
Bone mineral density	Change from Baseline Values at 1 year

Trial Locations

Locations (1)

Yukio Nakamura; 🇯🇵 Matsumoto, Nagano, Japan