- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06051344
Effect of Zoledronic Acid in Primary Knee Osteoarthritis
September 20, 2023 updated by: Toufiqe-E-Ealahi
Effect of Zoledronic Acid in Primary Knee Osteoarthritis: a Randomized Controlled Trial
We try to find out the effect of zoledronic acid over pain of primary knee osteoarthritis and also functional status in a period of 6 months.
Study Overview
Detailed Description
This will be a double blind placebo controlled randomized clinical trial at department of rheumatology, Bangabandhu Seikh Mujib Medical University (BSMMU) from January 2023 to December 2023.
Total 92 primary knee OA patients will be enrolled by following the inclusion criteria of ages 50 years and above with primary knee OA informed written consent.
Then randomization will be done into group A and group B following a randomization table, each consist of 46 patients.
Consecutive sampling technique will be followed.
Primary knee OA will be diagnosed on the basis of ACR clinical and radiological criteria.
Relevant laboratory investigations will be done.
Baseline pain status will be measured by Bangla version of Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), visual analog scale (VAS) and numerical rating scale (NRS) and quality of life will be measure by European quality of life scale (EQ-5D-5L).
Then one group will receive single infusion of 5mg zoledronic acid and another group will receive the placebo.
Each patient will be allowed take NSAIDs on requirement basis with documentation and follow non pharmacological treatment of OA.
At the end of 6 months, again pain and functional status will be measured by WOMAC scale
Study Type
Interventional
Enrollment (Estimated)
92
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nazrul islam, MD,FCPS
- Phone Number: 8801678112396
- Email: islam1nazrul@gmail.com
Study Contact Backup
- Name: kalam azad, FCPS,MD
- Phone Number: 8801911099075
- Email: azad1kalam@gmail.com
Study Locations
-
-
Shahbag
-
Dhaka, Shahbag, Bangladesh, 1000
- Recruiting
- Department of rheumatology
-
Contact:
- Nazrul islam, FCPS,MD
- Phone Number: +8801678112396
- Email: islam1nazrul@gmail.com
-
Contact:
- kalam azad, FCPS,MD
- Phone Number: +8801911099075
- Email: azad1kalam@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- >= 50 years
- Knee OA by ACR criteria
- Patient who will be willing to participate in the study
Exclusion Criteria:
- 1. Known inflammatory arthritis 2. BMI >= 40 kg/m2 3. Prior diagnosis of cancer 4. Prior use of bisphosphonates 5. Use of intra articular corticosteroid or hyaluronic acid preparations within 3months 6. Metabolic causes of OA (crystal associated arthritis, acromegaly, wilson's disease, haemachromatosis, Hyperparathyroidism, DM) 7. Mechanical causes of OA (epiphyseal dysplasia, congenital dislocations, limb-length inequality, hypermobility syndromes, avascular necrosis)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A, case group
. Total 92 primary knee OA patients will be enrolled by following the inclusion criteria of ages 50 years and above with primary knee OA informed written consent.
Then randomization will be done into group A and group B following a randomization table, each consist of 46 patients.
Consecutive sampling technique will be followed.
Primary knee OA will be diagnosed on the basis of ACR clinical and radiological criteria.
Relevant laboratory investigations will be done.
Baseline pain status will be measured by Bangla version of Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), visual analog scale (VAS) and numerical rating scale (NRS) and quality of life will be measure by European quality of life scale (EQ-5D-5L).
Then one group will receive single infusion of 5mg zoledronic acid and another group will receive the placebo
|
. Total 92 primary knee OA patients will be enrolled by following the inclusion criteria of ages 50 years and above with primary knee OA informed written consent.
Then randomization will be done into group A and group B following a randomization table, each consist of 46 patients.
Consecutive sampling technique will be followed.
Primary knee OA will be diagnosed on the basis of ACR clinical and radiological criteria.
Relevant laboratory investigations will be done.
Baseline pain status will be measured by Bangla version of Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), visual analog scale (VAS) and numerical rating scale (NRS) and quality of life will be measure by European quality of life scale (EQ-5D-5L).
Then one group will receive single infusion of 5mg zoledronic acid and another group will receive the placebo
|
Experimental: B, control group
. Total 92 primary knee OA patients will be enrolled by following the inclusion criteria of ages 50 years and above with primary knee OA informed written consent.
Then randomization will be done into group A and group B following a randomization table, each consist of 46 patients.
Consecutive sampling technique will be followed.
Primary knee OA will be diagnosed on the basis of ACR clinical and radiological criteria.
Relevant laboratory investigations will be done.
Baseline pain status will be measured by Bangla version of Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), visual analog scale (VAS) and numerical rating scale (NRS) and quality of life will be measure by European quality of life scale (EQ-5D-5L).
Then one group will receive single infusion of 5mg zoledronic acid and another group will receive the placebo
|
. Total 92 primary knee OA patients will be enrolled by following the inclusion criteria of ages 50 years and above with primary knee OA informed written consent.
Then randomization will be done into group A and group B following a randomization table, each consist of 46 patients.
Consecutive sampling technique will be followed.
Primary knee OA will be diagnosed on the basis of ACR clinical and radiological criteria.
Relevant laboratory investigations will be done.
Baseline pain status will be measured by Bangla version of Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), visual analog scale (VAS) and numerical rating scale (NRS) and quality of life will be measure by European quality of life scale (EQ-5D-5L).
Then one group will receive single infusion of 5mg zoledronic acid and another group will receive the placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain status
Time Frame: 0,3 and 6 month
|
by 1.
Western Ontario McMaster Universities Osteoarthritis index Total 24 domains.
Each domain range from none-0, mild-1, moderate -2, severe-3, extreme-4.
Total score ranging from 0 to 96
|
0,3 and 6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: kalam azad, FCPS MD, Rheumatologist
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
September 6, 2023
First Submitted That Met QC Criteria
September 20, 2023
First Posted (Actual)
September 22, 2023
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 20, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bisphosphonate in OA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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