SOYANEX

SOYANEX Softgel Capsules

Soya Isoflavones 40 mg + Alfacalcidol 0.25 mcg + Calcium Citrate 500 mg + Copper Sulphate 2 mg +
Magnesium Oxide 40 mg + Zinc Oxide 40 mg

SOYA ISOFLAVONES

Over the first years following menopause, due to hypoestrogenism, bone mass loss rapidly occurs and the risk
for osteoporosis largely increases. Only 8% to 10% of the women undergo HT to preserve bone mass.
Phytoestrogens have been proposed as an alternative to HT to prevent osteoporosis and show beneficial
effects on bone health. In the skeleton, isoflavones interact directly with bone cell estrogenic receptors. In
vitro, daidzein and genistein promote the growth and the differentiation of osteoblasts besides stimulating
bone formation. Blum et al. and Li & Yu demonstrated that, in ovariectomized rats, dietary soy had a beneficial
effect on bone health, sustaining bone formation and preventing bone resorption. On the other hand, Cai et
al., in a similar study, observed that isoflavone, in comparison with estradiol, did not prevent trabecular bone
loss without affecting calcium balance. Research on the effects of phytoestrogens on bone after menopause
is at a relatively early stage. The results of clinical studies, though variable, have been promising. Upon clinical
observation postmenopausal women with a high dietary consumption of isoflavone showed greater bone
mineral density values at both the spine and the hip. In 2003, Chen et al., in a double-blind, placebocontrolled
study, evaluated 203 postmenopausal women and observed that the hip bone mineral density was higher in
the group using 80 mg of isoflavone. In 2004, these same investigators observed that the effect of soy on bone
mass was more marked in women in later menopause or lower body weight. On the other hand, some
investigators detected no effect on bone mineral density after 6 to 12 months of soy isoflavone
supplementation. Morabito et al., in a double-blind, placebo-controlled clinical trial, studying bone markers
in women at early menopause, demonstrated that genistein reduced bone resorption and increased bone
formation. Similarly, Arjmandi et al. reported that soy supplementation positively influenced the insulin-like
growth factor (IGF-I), known to correlate with bone formation, and reduced urinary deoxypyridinoline, a
biomarker of bone resorption, in 71 postmenopausal women. IGF-I exerts a strong effect on cell proliferation
and differentiation. Although IGF-I declines with aging, there is evidence that its synthesis and activity are
affected by nutritional status as well as by insulin and gonadal steroids. Adams et al., observed no changes in
serum IGF-I in soy isoflavone users. The majority of the studies of the effects of isoflavone on bone mass is of
short duration, with relatively small sample sizes making it difficult to determine the significance of the
results. There are no studies available about bone fractures. The collective data suggest that diets rich in
isoflavone have bone-sparing effects although the magnitude of such effects and the exact mechanism of
action are speculative. To Weaver & Cheong, the beneficial effects of isoflavone on bone health are still
inconclusive.

ALFACALCIDOL

Alfacalcidol is fat soluble and upto 100% absorption normally takes place. After absorption, alfacalcidol is
rapidly hydroxylated at 2 position, predominantly in liver although the enzyme is widely distributed in body
tissues.1 Alfacalcidol (1a-hydroxyvitamin D3) undergoes rapid hepatic conversion to 1,25- dihydroxyvitamin
D3, which acts as a regulator of calcium and phosphate metabolism. Due to this rapid conversion, the
therapeutic benefits of alfacalcidol are virtually the same as those of 1,25- dihydroxyvitamin D3.2 The main
effects are to increase circulating 1,25-dihydroxyvitamin D3 levels, and thereby to increase intestinal
absorption of calcium and phosphate, promote bone mineralisation, regulate plasma parathyroid hormone
levels as well as to decrease bone resorption, with relief of bone and muscle pain.

Rationale for using alfacalcidol in different forms of osteoporosis

1. Increase of intestinal calcium absorption after activation in the liver
2.Decrease of PTH secretion by the parathyroid glands (= down-regulation of secondary
hyperparathyroidism
3. Antiresorptive effect on bone tissue by reducing activity of osteoclasts
4. Stimulatory effect on osteoblasts (osteoblasts have D-hormone receptors; alfacalcidol is activated in part
locally in bone tissue)
5. Improvement of mineralization of bone matrix and newly formed bone tissue
6. Positive effects on muscle metabolism and neuromuscular coordination (muscle cells have D-hormone
receptors
7. Immunosuppressive, immunomodulatory, and antiproliferative effects

INDICATIONS

1. Post-Menopausal Osteoporosis
2. Renal Osteodystrophy
3. Reckets / Osteomalacia
4. Pregnancy / Lactation
5. Senile Osteoporosis
6. Gluco-corticoid Induced Osteoporosis

DOSAGE

1 Capsule once or twice a day