StrokeNCT04652128
Effect of Zoledronic Acid on Prevention of Bone Loss in Acute Phase First-ever Stroke Patients
A study testing Zoledronic acid in people with Stroke, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Stroke
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jul 2019to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- A terminal medical diagnosis consistent with survival < 1 year
- Any Condition that would represent a contraindication to zoledronate, including allergy to zoledronate
- Previous bisphosphonate administration history, including zoledronate
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Severance Hospital
Seoul
Deog Young Kim, +82-02-2228-3700, KIMDY@yuhs.ac
About this study
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.
Read more
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
- Being tested
- Zoledronic acid, Placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Subject will receive a single infusion of zoledronic acid 5mg/100mL intravenously.
PlaceboDrug
Subject will receive a single infusion of physiological saline 100mL intravenously.
| Study group | Role | What they receive |
|---|---|---|
| zoledronate | Experimental | Subject will receive a single infusion of zoledronic acid 5mg/100mL intravenously. Receives: Drug: Zoledronic acid |
| saline | Placebo comparator | Subject will receive a single infusion of physiological saline 100mL intravenously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
BMD (Spine and femur, Whole body composition assessment) test using DEXA (dual energy x-ray absorptiometry) is performed.
Measured: 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.
Measured: 6 months
Bone mineral density
BMD (Spine and femur, Whole body composition assessment) test using DEXA (dual energy x-ray absorptiometry) is performed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start15 Jul 2019
- Primary completionJul 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deog Young Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652128
- Sponsor's protocol ID
- 4-2019-0496
- Status last verified
- Dec 2020
- First submitted
- 25 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zoledronic Acid on Prevention of Bone Loss in Acute Phase First-ever Stroke Patients
- ClinicalTrials.gov ID
- NCT04652128
- Acronym / sponsor ID
- 4-2019-0496
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zoledronate | Experimental | Drug: Zoledronic acidSubject will receive a single infusion of zoledronic acid 5mg/100mL intravenously. |
| saline | Placebo comparator | Drug: PlaceboSubject will receive a single infusion of physiological saline 100mL intravenously. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acidSubject will receive a single infusion of zoledronic acid 5mg/100mL intravenously. | Drug | zoledronate |
| PlaceboSubject will receive a single infusion of physiological saline 100mL intravenously. | Drug | saline |
Primary outcome
Bone mineral density
Time frame: up to 1 month
BMD (Spine and femur, Whole body composition assessment) test using DEXA (dual energy x-ray absorptiometry) is performed.
Bone mineral density
Time frame: 6 months
BMD (Spine and femur, Whole body composition assessment) test using DEXA (dual energy x-ray absorptiometry) is performed.
Bone mineral density
Time frame: 12 months
BMD (Spine and femur, Whole body composition assessment) test using DEXA (dual energy x-ray absorptiometry) is performed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deog Young Kim principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoledronic acid in people with Stroke, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deog Young Kim (+82-02-2228-3700, KIMDY@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.