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

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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02746068

Acronym

COAST-1

Enrollment

346

Registered

2016-04-21

Start date

2016-03-31

Completion date

2020-12-31

Last updated

2019-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Bone Marrow Lesions, AXS02, Axsome, Knee OA, Osteoarthritis

Brief summary

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.

Interventions

DRUGAXS-02

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Change in patient reported pain intensity	Baseline to Week 24	Patient reported pain intensity is recorded as an average daily pain intensity using an 11-point scale (0 = no pain to 10 = worst pain possible)

Secondary

Measure	Time frame
Patient Global Impression of Change (PGI-C)	Week 12 and Week 24
Clinical Global Impression of Change (CGI-C) scores	Week 12 and Week 24
Change in WOMAC pain and stiffness subscales over time	Baseline to Week 24

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026