NCT04652128

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 65 Years – 110 Years
• Healthy volunteers: Not accepted

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

• Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-15
• Primary completion: 2022-07-01
• Completion: 2023-02-01
• First posted: 2020-12-03
• Last updated: 2020-12-03

Locations

1 site across 1 country: South Korea