Status:
UNKNOWN
Effects of Omega-3 Fatty Acids on Bone and Frailty
Lead Sponsor:
Donaghue Medical Research Foundation
Collaborating Sponsors:
University of Connecticut
Conditions:
Osteoporosis
Frailty
Eligibility:
FEMALE
65+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to examine the effects of essential fatty acid (EFA) supplementation on bone metabolism and frailty in postmenopausal women. The overall hypothesis is that EFA supplementa...
Detailed Description
Osteoporosis is a bone thinning disease that results in fractures that occur with minimal trauma. The direct health care costs related to osteoporosis are estimated to be $14 billion per year, compara...
Eligibility Criteria
Inclusion
- Postmenopausal women over 65 years old
- Spine or hip bone density T score less than -1
- Hand grip strength 2 standard deviations below weight adjusted norms
- Able to travel to the clinical sites for follow-up visits
Exclusion
- Any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism)
- Cancer of any kind (except basal or squamous cell of skin) in past 5 years.
- Use of calcitonin, calcitriol, heparin, phenytoin, phenobarbital, and estrogen in the past 6 months
- Use of bisphosphonates, long-term corticosteroids (more than 6 months), methotrexate, or fluoride at any time
- Current use of any medication or herbs with anticoagulant or antiplatelet activity, tetracycline, and magnesium or zinc supplementation
- Estimated creatinine clearance less than 50 ml/min
- History of chronic liver disease or evidence of liver disease on screening
- History of hip fracture or known vertebral fracture within the past year
- Untreated hypertension or a history of clotting disorders
- History of allergy to fish or fish oil
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00634686
Start Date
January 1 2007
End Date
June 1 2009
Last Update
February 2 2009
Active Locations (1)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030