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



Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:50 - Any
Updated:1/12/2019
Start Date:March 2016
End Date:December 2020

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COAST -1: Clinical Knee Osteoarthritis Symptom Treatment 1 Study. 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.

This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the
efficacy and safety of AXS-02 in subjects with knee osteoarthritis associated with bone
marrow lesions.


Key Inclusion Criteria:

- Male at least 50 years of age, or postmenopausal female

- Meets the ACR clinical criteria for knee osteoarthritis

- Bone Marrow Lesion of the knee present on MRI

- Additional criteria may apply

Key Exclusion Criteria:

- Previous surgery on index knee

- Any prior use of bisphosphonates within 6 months of screening

- Additional criteria may apply
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Newport News, VA
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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Birmingham, AL
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3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
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Duncansville, Pennsylvania 16635
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