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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04652128
• Other study ID #: 4-2019-0496
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: February 2023

Study information

• Verified date: December 2020
• Source: Yonsei University
• Contact: Deog Young Kim
• Phone: +82-02-2228-3700
• Email: KIMDY[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: February 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

Inclusion Criteria:

1. Hemiplegia due to first-ever ischemic and/or hemorrhagic stroke

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:

1. Progressive or unstable stroke

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Bone mineral density	BMD (Spine and femur, Whole body composition assessment) test using DEXA (dual energy x-ray absorptiometry) is performed.	6 months
Primary	Bone mineral density	BMD (Spine and femur, Whole body composition assessment) test using DEXA (dual energy x-ray absorptiometry) is performed.	12 months