Effect of Zoledronic Acid in Primary Knee Osteoarthritis

NCT06051344 | Unknown Phase 4

• 1 other identifier: Bisphosphonate in OA
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A, case group

EXPERIMENTAL

. 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

B, control group

EXPERIMENTAL

. 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

Interventions

Zoledronic acid DRUG

. 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

A, case group; B, control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 50 years
• Knee OA by ACR criteria
• Patient who will be willing to participate in the study

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Toufiqe-E-Ealahi: lead

Study Sites (1)

Department of rheumatology

Dhaka, Shahbag, 1000, Bangladesh

RECRUITING

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• kalam azad, FCPS MD

  Rheumatologist

  STUDY CHAIR

Central Study Contacts

Nazrul islam, MD,FCPS

CONTACT

8801678112396; islam1nazrul@gmail.com

kalam azad, FCPS,MD

CONTACT

8801911099075; azad1kalam@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: . 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

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 22, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)