Expired Study
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New York, New York 10032


Purpose:

Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint pain/stiffness associated with aromatase inhibitors


Criteria:

Inclusion Criteria: - Age >21 years - Postmenopausal status defined as cessation of menses for >1 year or FSH >20 mIU/mL - History of stage I, II or IIIA hormone receptor-positive breast cancer, without metastatic disease - Currently taking a third-generation aromatase inhibitor for at least 3 months - Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry - Ongoing musculoskeletal pain/stiffness in hand and/or knee joints (50 or higher on the 100 point global assessment VAS) that started or increased since initiating aromatase inhibitor therapy, and has been present for at least 3 months. - patients must agree to refrain from use of glucosamine and chondroitin from sources outside of this study - If taking bisphosphonates, on a stable dose for at least 3 months and tolerating the dose. Patients must agree to refrain from initiating bisphosphonate use during the course of the study. - ECOG performance status 0-2. - Hemoglobin A1c <8. - Signed informed consent Exclusion Criteria: - se of glucosamine or chondroitin within the past six months - Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: - Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica) - gout - episodes of acute monarticular arthritis clinically consistent with pseudogout - Paget's disease affecting the study joint - a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint - Wilson's disease - hemochromatosis - alkaptonuria - primary osteochondromatosis - History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion). - History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry. - AST, ALT > 2x normal. - Serum Creatinine of > 1.8 mg/dl. - Uncontrolled hypertension (Systolic Blood Pressure of > 150 mm Hg or Diastolic Blood Pressure of >95 mm Hg). - Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of > 8%.


NCT ID:

NCT00691678


Primary Contact:

Principal Investigator
Dawn Hershman, MD
Columbia University


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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