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

NCT04652128 | Unknown

• 1 other identifier: 4-2019-0496
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Bone mineral density

  BMD (Spine and femur, Whole body composition assessment) test using DEXA (dual energy x-ray absorptiometry) is performed.

  up to 1 month

• Bone mineral density

  BMD (Spine and femur, Whole body composition assessment) test using DEXA (dual energy x-ray absorptiometry) is performed.

  6 months

• Bone mineral density

  BMD (Spine and femur, Whole body composition assessment) test using DEXA (dual energy x-ray absorptiometry) is performed.

  12 months

Study Arms (2)

zoledronate

EXPERIMENTAL

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

Drug: Zoledronic acid

saline

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Zoledronic acid DRUG

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

zoledronate

Placebo DRUG

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

saline

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Hemiplegia due to first-ever ischemic and/or hemorrhagic stroke
• Stroke confirmed by CT or MRI
• Acute/Subacute stage: less than 1months after onset
• Men or women 65 years of age or older
• T-score between -1.0 and -2.5 (osteopenia patients)
• Previously walk independent
• Initial stroke severity is mild to moderately severe to very severe with an initial NIHSS score of 5 or more after the onset
• Unable to walk 1 week after stroke onset, (Functional Ambulatory Category \[FAC\]\<2)
• Severe motor function involvement (Total of FMA: \< 50)
• Written informed consent

You may not qualify if:

• Progressive or unstable stroke
• Pre-existing and active major neurological disease
• Previously diagnosed as osteoporosis
• Lactating Mother or pregnant woman
• Hypocalcemia(\<8.8mg/dL or 2.1mmol/L), hypomagnesemia( \<1.7 mg/dL or 0.7mmol/L) or Hypophosphatemia (\<2.5 mg/dL or 0.81mmol/L)
• History of Thyroid Surgery, Hypoparathyroidism or Small Intestine Excision
• Fracture history of BMD site (L1-L5 or femur head)
• Creatinine clearance rate \<35 mL/min, Severe Renal Disease or under current treatment with an aminoglycoside antibiotic
• Dehydration
• Malabsorption States
• History of Bronchial Asthma
• Recent Invasive Dental Procedure
• History of Aseptic Necrosis of Jaw Bone
• A history of significant alcohol or drug abuse in the prior 3 years
• Advanced liver, cardiac, or pulmonary disease

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Deog Young Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deog Young Kim

CONTACT

+82-02-2228-3700; KIMDY@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: July 15, 2019
• Primary Completion: July 1, 2022
• Study Completion: February 1, 2023
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)