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Effect of Zoledronic Acid in Primary Knee Osteoarthritis

Primary Purpose

Primary Osteoarthritis

Status
Recruiting
Phase
Phase 4
Locations
Bangladesh
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Toufiqe-E-Ealahi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of rheumatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A, case group

B, control group

Arm 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

. 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

Outcomes

Primary Outcome Measures

Pain status
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

Secondary Outcome Measures

Full Information

First Posted
September 6, 2023
Last Updated
September 20, 2023
Sponsor
Toufiqe-E-Ealahi
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1. Study Identification

Unique Protocol Identification Number
NCT06051344
Brief Title
Effect of Zoledronic Acid in Primary Knee Osteoarthritis
Official Title
Effect of Zoledronic Acid in Primary Knee Osteoarthritis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Toufiqe-E-Ealahi

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A, case group
Arm Type
Experimental
Arm 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
Arm Title
B, control group
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Intervention 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
Primary Outcome Measure Information:
Title
Pain status
Description
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
Time Frame
0,3 and 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nazrul islam, MD,FCPS
Phone
8801678112396
Email
islam1nazrul@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
kalam azad, FCPS,MD
Phone
8801911099075
Email
azad1kalam@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kalam azad, FCPS MD
Organizational Affiliation
Rheumatologist
Official's Role
Study Chair
Facility Information:
Facility Name
Department of rheumatology
City
Dhaka
State/Province
Shahbag
ZIP/Postal Code
1000
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazrul islam, FCPS,MD
Phone
+8801678112396
Email
islam1nazrul@gmail.com
First Name & Middle Initial & Last Name & Degree
kalam azad, FCPS,MD
Phone
+8801911099075
Email
azad1kalam@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Zoledronic Acid in Primary Knee Osteoarthritis

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