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Effect of Zoledronic Acid in Primary Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT06051344
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Toufiqe-E-Ealahi, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Osteoarthritis Drug: Zoledronic acid Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: . 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
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Zoledronic Acid in Primary Knee Osteoarthritis: a Randomized Controlled Trial
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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
 Drug: Zoledronic acid
. 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
 Drug: Zoledronic acid
. 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. >= 50 years
  2. Knee OA by ACR criteria
  3. 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051344


Contacts
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Contact: Nazrul islam, MD,FCPS 8801678112396 islam1nazrul@gmail.com
Contact: kalam azad, FCPS,MD 8801911099075 azad1kalam@gmail.com

Locations
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Bangladesh
Department of rheumatology Recruiting
Dhaka, Shahbag, Bangladesh, 1000
Contact: Nazrul islam, FCPS,MD    +8801678112396    islam1nazrul@gmail.com   
Contact: kalam azad, FCPS,MD    +8801911099075    azad1kalam@gmail.com   
Sponsors and Collaborators
Toufiqe-E-Ealahi
Investigators
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Study Chair: kalam azad, FCPS MD Rheumatologist
More Information
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Responsible Party: Toufiqe-E-Ealahi, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT06051344    
Other Study ID Numbers: Bisphosphonate in OA
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs