Effects of Omega-3 Fatty Acids on Bone and Frailty

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Osteoporosis, Frailty

In brief

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 supplementation, via its immunoregulatory and anti-inflammatory activity, will decrease bone turnover, decrease prostaglandins and cytokines associated with bone metabolism and frailty, and change physical outcome measures associated with frailty in postmenopausal women with low bone mass and frailty.

Key facts

Study ID

NCT00634686

Run by

Donaghue Medical Research Foundation

People needed

150

Starts

2007-01-01

Expected to finish

2009-06-01

Last updated by the study team

2009-02-02

Who can join

Age: 65 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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