Effects of Omega-3 Fatty Acids on Bone and Frailty

Donaghue Medical Research Foundation

Status and phase

Unknown

Phase 4

Conditions

Osteoporosis

Frailty

Treatments

Dietary Supplement: DHA/EPA

Dietary Supplement: Placebo capsule

Dietary Supplement: Calcium with vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT00634686

AG0096

Details and patient eligibility

About

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.

Full 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, comparable to costs in heart failure and asthma. Frailty, or poor physiologic reserve to deal with stressors, is estimated to be 7% in the general population over age 65. The frailty syndrome is characterized by sarcopenia or muscle loss, inflammation, low estrogen, growth hormone and testosterone levels, poor nutrition and disability, and is associated with an increased risk of falls and fracture. Omega-3 fatty acids found in fish oil (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) have been shown to decrease markers of inflammation (cytokines) and decrease death due to heart disease. A number of studies in animals suggest that fish oil (EPA and DHA) supplementation inhibits bone break down, increases calcium absorbed from the diet and enhances calcium in bone. Few studies have assessed the role of n-6 and n-3 fatty acids in the diet in bone disease in humans. As far as we know, no study has evaluated the role of n-3 fatty acids in the frailty syndrome.

Enrollment

150 estimated patients

Sex

Female

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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