Effect of a combination of genistein, polyunsaturated fatty acids and vitamins D3 and K1 on bone mineral density in postmenopausal women: a randomized, placebo-controlled, double-blind pilot study.
OBJECTIVE
Many postmenopausal women desire non-pharmaceutical alternatives to hormone therapy for protection against osteoporosis. Soybean isoflavones, especially genistein, are being studied for this purpose. This study examined the effects of synthetic genistein in combination with other potential bone-protective dietary molecules on bone mineral density (BMD) in early postmenopausal women.


METHODS
In this 6-month double-blind pilot study, 70 subjects were randomized to receive daily either calcium only or the geniVida™ bone blend (GBB), which consisted of genistein (30 mg/days), vitamin D3 (800 IU/days), vitamin K1 (150 μg/days) and polyunsaturated fatty acids (1 g polyunsaturated fatty acids as ethyl ester: eicosapentaenoic acid/docosahexaenoic acid ratio = ~2/1). Markers of bone resorption and formation and BMD at the femoral neck, lumbar spine, Ward's triangle, trochanter and intertrochanter, total hip and whole body were assessed.


RESULTS
Subjects supplemented with the GBB (n = 30) maintained femoral neck BMD, whereas in the placebo group (n = 28), BMD significantly decreased (p = 0.007). There was also a significant difference (p < 0.05) in BMD between the groups at Ward's triangle in favor of the GBB group. Bone-specific alkaline phosphatase and N-telopeptide significantly increased in the GBB group in comparison with those in baseline and in the placebo group. The GBB was well tolerated, and there were no significant differences in adverse events between groups.


CONCLUSIONS
The GBB may help to prevent osteoporosis and reduce fracture risk, at least at the hip, in postmenopausal women. Larger and longer-term clinical trials are warranted.
Osteoporosis Research Center, Creighton University Medical Center, 601 North 30th Street, Suite 4820, Omaha, NE 68131, USA.e-mail: jmlappe@creighton.edu
Joan
J
Lappe
Iris
I
Kunz
Igor
I
Bendik
Kevin
K
Prudence
Peter
P
Weber
Robert
R
Recker
Robert P
RP
Heaney
D015519:Bone Density / Q000187:drug effects*; D001862:Bone Resorption / Q000517:prevention & control; D002136:Calcium, Dietary / Q000008:administration & dosage; D002762:Cholecalciferol / Q000008:administration & dosage*; D004311:Double-Blind Method; D005231:Fatty Acids, Unsaturated / Q000008:administration & dosage*; D005260:Female; D005269:Femur / Q000187:drug effects / Q000378:metabolism; D005272:Femur Neck / Q000187:drug effects / Q000378:metabolism; D019833:Genistein / Q000008:administration & dosage*; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects / Q000378:metabolism; D008875:Middle Aged; D009043:Motor Activity; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D010349:Patient Compliance; D010865:Pilot Projects; D010837:Vitamin K 1 / Q000008:administration & dosage*; D014815:Vitamins / Q000008:administration & dosage
D002136:Calcium, Dietary; D005231:Fatty Acids, Unsaturated; D014815:Vitamins; D002762:Cholecalciferol; D010837:Vitamin K 1; D019833:Genistein