MedTrace Logo

Effect of Zoledronic Acid on Prevention of Bone Loss in Acute Phase First-ever Stroke Patients

NCT04652128 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-12-03

No results posted yet for this study

Summary

In order to reduce the incidence of fractures due to osteopenia, osteoporosis, and bone mineral density in first stroke patients, the purpose of this study was to determine whether it is meaningful to administer zoledronic acid prophylactically, and to define the characteristics of the patient group that can benefit.

Subjects suitable for the selection criteria are divided into an experimental group (zoledronic acid group) and a control group (physiological saline group) in random permuted blocks. Random assignment means that a coin is thrown and assigned to the experimental group or the control group with the probability of a head or tail, and is assigned using a random number table.

The comparison-control group was designed to analyze and compare whether there is a significant effect of preventing the decrease in bone density in the group administered zoledronic acid through the double-blind experimental group and the control group.

The reason why physiological saline was selected as a reference drug was to double-blind with zoledronic acid, because it does not affect the subject's bone density and has a very low possibility of side effects, and its transparent properties are similar to that of zoledronic acid.

Subjects undergo a bone density (BMD-Spine and femur, Whole Body Composition Assessment) test using DEXA (dual energy x-ray absorptiometry) through outpatient or hospitalization at the Department of Rehabilitation within one month after the onset of stroke.

Subsequently, the subject will receive a single infusion of zoledronic acid 5mg/100mL or physiological saline 100mL intravenously at the outpatient or inpatient ward depending on the group. Subsequently, the subject will receive a single infusion of zoledronic acid 5mg/100mL or physiological saline 100mL intravenously at the outpatient or inpatient ward depending on the group.

Each subject or guardian fills in the questionnaire form at the time of the first injection, 6 months and 12 months after the injection, and immediately sees the fractures, side effects, and changes in drugs taken from the last survey to the present.

At the first injection, 6 months and 12 months after the injection, the above examination (bone density) is performed through an outpatient department of rehabilitation medicine, and by type known to be related to zoledronic acid administration such as fractures during the period (primary fragile fracture, non-spine fragile fracture, Symptom fracture, spine fracture, etc.)

Conditions

Interventions

DRUG

Zoledronic acid

Subject will receive a single infusion of zoledronic acid 5mg/100mL intravenously.

DRUG

Placebo

Subject will receive a single infusion of physiological saline 100mL intravenously.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Deog Young Kim · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2022-07-31
Completion
2023-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652128 on ClinicalTrials.gov