Effect of Zoledronic Acid on Prevention of Bone Loss in Acute Phase First-ever Stroke Patients
NCT ID: NCT04652128
Last Updated: 2020-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
56 participants
INTERVENTIONAL
2019-07-15
2023-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.)
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
zoledronate
Subject will receive a single infusion of zoledronic acid 5mg/100mL intravenously.
Zoledronic acid
Subject will receive a single infusion of zoledronic acid 5mg/100mL intravenously.
saline
Subject will receive a single infusion of physiological saline 100mL intravenously.
Placebo
Subject will receive a single infusion of physiological saline 100mL intravenously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zoledronic acid
Subject will receive a single infusion of zoledronic acid 5mg/100mL intravenously.
Placebo
Subject will receive a single infusion of physiological saline 100mL intravenously.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Stroke confirmed by CT or MRI
3. Acute/Subacute stage: less than 1months after onset
4. Men or women 65 years of age or older
5. T-score between -1.0 and -2.5 (osteopenia patients)
6. Previously walk independent
7. Initial stroke severity is mild to moderately severe to very severe with an initial NIHSS score of 5 or more after the onset
8. Unable to walk 1 week after stroke onset, (Functional Ambulatory Category \[FAC\]\<2)
9. Severe motor function involvement (Total of FMA: \< 50)
10. Written informed consent
Exclusion Criteria
2. Pre-existing and active major neurological disease
3. Previously diagnosed as osteoporosis
4. Lactating Mother or pregnant woman
5. 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)
6. History of Thyroid Surgery, Hypoparathyroidism or Small Intestine Excision
7. Fracture history of BMD site (L1-L5 or femur head)
8. Creatinine clearance rate \<35 mL/min, Severe Renal Disease or under current treatment with an aminoglycoside antibiotic
9. Dehydration
10. Malabsorption States
11. History of Bronchial Asthma
12. Recent Invasive Dental Procedure
13. History of Aseptic Necrosis of Jaw Bone
14. A history of significant alcohol or drug abuse in the prior 3 years
15. Advanced liver, cardiac, or pulmonary disease
16. A terminal medical diagnosis consistent with survival \< 1 year
17. Any Condition that would represent a contraindication to zoledronate, including allergy to zoledronate
18. Previous bisphosphonate administration history, including zoledronate
65 Years
110 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yonsei University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Deog Young Kim
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yonsei Severance Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Deog Young Kim
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4-2019-0496
Identifier Type: -
Identifier Source: org_study_id