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A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated with Bone Marrow Lesions (COAST-I)


Title A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects with Knee Osteoarthritis Associated with Bone Marrow Lesions.
Therapeutic Area Osteoarthritis, Joint Disorders
Principal Investigator Steven C. Vlad, MD, PhD
Min Age 50 Years
Gender Both
Contact Ifeoma Onwubiko, MD, MPH
617-636-5727
More Information https://clinicaltrials.gov/ct2/show/NCT02746068

Overview

This is a phase 3 trial for the treatment of knee osteoarthritis associated with bone marrow lesions. The purpose of the study is to determine whether a study medication, AXS02 (disodium zoledronate tetrahydrate) can reduce bone marrow lesions, and therefore alleviate pain associated with osteoarthritis of the knee. AXS02 is an investigational drug and subjects are monitored to see if it causes any adverse event. Maximum participation is 21 weeks and may include up to 14 visits to Tufts Medical Center. A total of approximately 346 subjects are planned for enrollment. Subjects who are eligible for the study will receive AXS02 or placebo during visits 4-8 (1 tablet per week for 6 weeks). The following 6 visits consist of a number of tests and procedures to gather data.

Study Details

Inclusion Criteria

  • Subject must have radiographic evidence of knee osteoarthritis
  • Subject must discontinue pain medications for 2 ten day periods during the study.
  • Subject must be able to complete daily e-diary.

Exclusion Criteria

  • Diagnosed with psychiatric disorder (e.g. major depression, schizophrenia, bipolar disorder, panic disorder, generalized anxiety disorder) within the past 2 years.
  • Surgery or invasive therapy to your knee in past 3 months.
  • Tooth extraction or invasive dental procedure within the past 3 months.

Study Requirements

14 visits, 27 weeks, 3 MRIs, 3 x-rays, 9 blood draws, daily e-diary completion