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 |
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.
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
We found this trial at
55
sites
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
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