Effect of Zoledronic Acid in Primary Knee Osteoarthritis

Primary Osteoarthritis Clinical Trial

Official title:

Effect of Zoledronic Acid in Primary Knee Osteoarthritis: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051344
• Other study ID #: Bisphosphonate in OA
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: Nazrul islam, MD,FCPS
• Phone: 8801678112396
• Email: islam1nazrul[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Primary Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Bangladesh	Department of rheumatology	Dhaka	Shahbag

Sponsors (1)

Lead Sponsor	Collaborator
Toufiqe-E-Ealahi

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0,3 and 6 month