Efficacy of Zoledronic Acid in Osteoporosis

Shinshu University

Status and phase: Enrolling; Phase 2

Conditions: Osteoporosis

Treatments: Drug: "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"; Drug: "Zoledronic acid", "Reclast®"

Study type: Interventional

Funder types: Other

Identifiers

NCT03183557

Zol2017

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

ZA alone

Active Comparator group

Treatment:

Drug: "Zoledronic acid", "Reclast®"

ZA plus VD

Active Comparator group

Treatment:

Drug: "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"