OsteoPhase
Technical Review and References
Osteoporosis
and Calcum Dysregulation
Osteoporosis, or porous bone, is a skeletal disease characterized
by low bone mass and deterioration of the structure of bone
tissue. Osteoporosis is marked by bone fragility and increased
risk of fractures, especially of the hip, spine, and wrist.
Osteoporosis is not,
however, an isolated disorder. The calcium lost from bone
tissue floods and overloads body fluids and tissues. Because
of the central role of calcium in all cell metabolism, this
overload of calcium contributes to a multitude of other disorders.
Researchers find that when calcium is deficient in skeletal
bone, it is elevated in the blood and within tissue cells.
While our bones become fragile and brittle, our arteries calcify,
and our endocrine secretions, including insulin are disrupted.
At the same time our muscle, nerve, and other cells lose function
as they become overloaded with calcium.
The underlying mechanism
that connects these disorders is loss of calcium ion homeostasis,
or dysregulation of calcium ion flow. The problem of faulty
calcium homeostasis is not solved by calcium supplementation,
but by restoring proper regulation of calcium ion flow.
Clinical evaluation
in China of OsteoPhase was based on a regulating dose of the
formulation that contained less than 125 mg. per day of calcium.
This level of calcium intake is far below the 1000 to 1500
mg. of daily calcium supplementation recommended by nutritionists
and physicians in the US and elsewhere to protect against
bone loss. This fact also supports the hypothesis that the
formula achieves its results by calcium regulation and not
by supplementation.
OsteoPhase is a marine-based
nutritional product developed through ten years of research.
The formula is a unique supplement made from Concha ostrea
(Ostrea talienwhanensis - an oyster shell), Astragalus polysaccharides,
Angelica sinensis root, and Coix seeds. All are common ingredients
used for nutritional and therapeutic purposes in modern Chinese
medicine. OsteoPhase is manufactured by a patented, high-tech
process and contains ionic calcium (Ca2+), astragalus polysaccharides,
21 different amino acids, iron, zinc, and other biologically
active molecules.
The ability of OsteoPhase
to regulate calcium ion homeostasis is attributed to its unique
ratio of ingredients and to a special manufacturing process
developed at a marine medicine institute. The lead researcher
at the institute identified biologically active proteins and
enzymes from the inner lining of the oyster shell that are
responsible for stimulating the formation of the shell from
available calcium. He then developed a proprietary process
for extracting these bioactive ingredients along with ionic
calcium from the shell and combined them with three medicinal
herbs that contribute to calcium regulation. The result of
his work is the OsteoPhase formula, now available to men and
women in the US that suffer from osteoporosis and the damage
caused by the flooding of cells and soft tissues of calcium
leached from bone tissue by various causes.
Osteoporosis
Morbidity
Osteoporosis is a major public health problem in the US and
worldwide. An estimated 10 million Americans already have
the disease with another 34 million having low bone mass,
or osteopenia, putting them at increased risk for osteoporosis
and fracture.
One in two women,
and one in four men over age 50 will have a fracture related
to low bone mass in his or her remaining lifetime. More than
1.5 million fractures are attributed to osteoporosis annually,
including:
- 300,000 plus hip fractures
- 700,000 vertebral fractures
- 250,000 wrist fractures
- 300,000 fractures at other sites
The estimated costs
associated with these fractures nationally for medical care
in hospitals and nursing homes was $17 billion in 2001.
Hip fractures are
the most problematic of the various fractures. An average
of almost 25% of hip fracture patients over age 50 die in
the year following their fracture. While the rate of hip fractures
in women is two to three times higher than in men, the one
year mortality rate is nearly twice as high for men.
At six months after
a hip fracture, only about 15% of patients can walk across
a room unaided.
Bone
Physiology
In order to understand the causes and effects of osteoporosis,
it is important to know that bone is living tissue. Structurally,
our bones serve as a scaffold for the musculoskeletal system
and protect internal organs. Just as importantly, bone tissue
is an important metabolic reservoir, centrally involved in
hemopoeisis, or blood formation, and in calcium homeostasis.
After we reach adulthood
our bones no longer continue to grow in length. However, just
like all other tissues of the body, bones do continue to renew
themselves in a process called bone remodeling. Old bone is
constantly being replaced by new bone. New bone is stronger
than old bone, so bone remodeling is important in maintaining
bone strength. It is also crucial to maintain the ongoing
contribution of bone tissue to calcium regulation and blood
formation.
Bone remodeling is
controlled by two types of bone cells – osteoclasts
and osteoblasts. Osteoclasts and osteoblasts work together
to form new bone.
Osteoclasts secrete
an acid like substance that dissolves bone mineral and digests
bone matrix leaving small cavities or pits in bone tissue.
This process is called bone resorption.Osteoblasts
then refill the cavity with new bone, called osteoid. The
osteoblasts first synthesize bone matrix, 90% of which is
made up of type I collagen. In the next stage the osteoid
matrix is mineralized with calcium hydroxyapatite crystals,
completing the formation of new bone.
Osteoporosis
Pathology
The matrix of all bones consists of two types of microstructure
– trabecular bone tissue or cortical bone tissue. The
spine and vertebrae are mainly trabecular bone. The ends of
the long bones of the body are 75% trabecular and 25% cortical.
The rest of the long bones are cortical. Bone remodeling,
or replacement of weak, old bone with new, strong bone is
more active in trabecular bone where 40% of all bone tissue
is recycled each year. In cortical bone, only 10% is remodeled
each year.
Healthy bone mass
is maintained when the resorption and formation phases of
bone remodeling are balanced when osteoclasts and osteoblasts
work together as a unit. Bone loss occurs when the functions
of osteoclasts and osteoblasts are uncoupled.
When bone remodeling becomes faulty, as in osteoporosis, it
does most of its damage in trabecular bone tissue, which is
why most osteoporotic fractures occur at the following locations:
- Vertebrae of the spine
- Neck of the femoral bone at the
hip
- Ends of long bones, in particular
the radius of the wrist
Primary, or involutional,
post-menopausal bone loss accounts for 80% of all osteoporotic
fractures. Involutional bone loss takes two forms –
in Type I, osteoclast activity is excessive and in Type II,
osteoblast activity is hindered.
- Type I. Accelerated
bone loss in recently menopausal women is associated with
overactive osteoclasts and is closely related to loss of
ovarian function. Excessive osteoclast activity creates
resorptive cavities that are too deep for osteoblasts to
fill with new osteoid matrix. This type of bone loss occurs
mainly in trabecular bone tissue. Women lose 5-10% of their
bone mass in the first five years after their last menstrual
period. More than 40% of all women aged 50-75 will experience
low energy osteoporotic fractures. The tendency is for them
to experience vertebral fractures from age 55 to 70 and
femoral fractures over age 70.
- Type II. Slower,
age-dependent bone loss results from osteoblast underactivity.
After the accelerated bone mass loss in the five years after
menopause, women lose about 1% of their bone mass per year.
In Type II involutional osteoporosis osteoblasts cannot
adequately fill normal resorptive cavities with new osteoid
matrix. This bone loss concentrates in the cortical bone
tissue that is the primary tissue of skeletal long bones.
Secondary osteoporosis
accompanies many medical conditions, including hyperthyroidism,
hyperparathyroidism, diabetes, adrenocortical overactivity,
rheumatoid arthritis, and chronic use of various medications,
particularly corticosteroids. Secondary osteoporosis is also
a consequence of chronic alcohol abuse and smoking addiction.
The best way to determine
risk is to have a bone mass density test. Several types of
devices measure loss in bone mass density and indicate development
of osteoporosis with a high degree of accuracy. These devices
give scores that indicate bone loss compared to normal healthy
subjects. The following chart gives the definitions of degrees
of bone loss and recommended levels of intake of the OsteoPhase
capsules.
| Normal |
Bone density score
of +1 SD to –1 SD of young adult mean
[SD is Standard Deviations] |
1 capsule daily as
preventative |
| Low Bone Mass or Osteopenia |
Bone density score of –1
to –2.5 SD [Density is 1-2.5 Standard Deviations
below the young adult mean] |
3 capsules daily as restorative |
| Osteoporosis |
Bone density score of >-2.5
SD [Density is 2.5 Standard Deviations or more below the
young adult mean] |
6 capsules daily as restorative |
| Severe [established]
Osteoporosis |
Bone density score of >-2.5
SD, and one or more osteoporotic fractures |
6-9 capsules daily as restorative |
It is recommended
that a follow-up bone mass density test take place after three
months use of OsteoPhase. Daily use can then be adjusted based
on the results of the test.
Calcium
Regulation and Homeostasis
A large part of physiology is concerned with regulatory mechanisms
that act to maintain healthy internal function. Calcium ions
are the most important molecules that serve as regulatory
signals. After acting to initiate various physiological functions,
from nerve and muscle cell firing to release of hormones into
the blood stream, calcium is restored to its set points in
various cells and tissues by different homeostatic feedback
loops. There is a constant shifting of calcium from its various
storage locations in bone, blood, tissue fluids, and cells.
When this shifting goes awry, calcium dysregulation occurs
and many tissues lose optimal function.
Calcium dysregulation
becomes an underlying cause of many disorders, from cardiovascular
disease to diabetes. While our bones become fragile, our soft
tissues become inflamed and calcified. The impact of OsteoPhase
on cardiovascular disease is based on its ability to antagonize
elevated levels of calcium in the blood and interrupt calcification,
plaquing and fibrosis in arterial tissues. In diabetes, calcium
overload disrupts the interplay between glucose levels and
calcium ions in the release of insulin.
Research scientists are analyzing the central
role of calcium dysregulation in Alzheimer’s disease,
nerve cell damage, kidney nephrosis, bi-polar disorder, muscular
dystrophies, periodontal disease, non-healing of fractures,
tumor cell proliferation.
Initial research on OsteoPhase in China
indicates that it regulates calcium homeostasis by increasing
bone density and by antagonizing high calcium levels in the
blood and cells. While this positive aspect of the formula
is awaiting further verification through clinical evaluation,
the initial results are very promising. The formula itself
is very safe for daily use as all of the herbs are common
medicinals in wide use in health formulations throughout Asia,
the US and Europe. The four ingredients in OsteoPhase are
key Essence herbs thought to play beneficial roles in maintaining
optimal health as we age. The “side effects” of
regular use in preventing and restoring bone loss will be
improved immune system function, better cell regulation, and
enhanced overall health for both men and women.
OsteoPhase
Ingredients
The physiological effects of OsteoPhase on bone tissue are
supported by independent studies of the four ingredients that
compose the formula as indicated below.
(Ostrea talienwhanensis, Oyster shell)
Concha Ostrea contains calcium carbonate [80-85%], calcium
phosphate, calcium sulfate, magnesium, ferric oxide, silicon
dioxide, glycogen, betain, taurine, glutathione, keratin,
oburidine, adenine, venerupin, glycolipid, lysine, tyrosine,
methionine, leucine, arginine, histidine, threonine, valine,
succinic acid, sterol, fats, vitamins A, B1, B2, D.
Oyster shell is commonly used in traditional Chinese
medicine for heart palpitations accompanied by anxiety,
restlessness and insomnia. Additionally, oyster shell
is used in reducing various types of swellings. Research
in Japan and China indicates that both hydrolysed and
electrolysed oyster shell increases calcium absorption
and improves bone density.
(Radix Astragali, Astragalus membranaceus)
Polysaccharides from Radix Astragali (Astragalus) are
well studied as potent immune modulators and are particularly
valuable in restoring depressed immunity. They have been
shown to partially reverse the effect of prednisolone
in mice, which may account for its contribution to countering
the effects of chronic corticosteroid use on rates of
osteoporosis formation.
In post-menopausal women, osteoclast activity
increases over osteoblasts activity due to decline in
estrogen production. This uncoupling or imbalance in breakdown
of old bone and stimulation of new bone formation leads
to the dramatic losses of bone mass in women after their
last menstrual period at the beginning of menopause.
Ovariectomy, the surgical removal of the ovaries, induces
bone loss and is used to study the effects of a decrease
in estrogen on bone tissue. Extracts of Astragalus inhibit
bone loss in ovariectomized rats. This herb alone will
likely contribute to the prevention of bone loss in
post-menopausal women who were counting on hormone replacement
therapy for this purpose.
Angelica sinensis is an herbal medicine known for its
effect to purify blood quality and improve circulation.
It frequently appears as the main ingredient in herbal
prescriptions for bone injuries. An aqueous extract of
Angelica sinensis was found to directly stimulate the
proliferation, alkaline phosphatase (ALP) activity, protein
secretion and particularly type I collagen synthesis of
OPC-1 in a dose-dependent manner. OPC-1 are bone marrow
osteoprecursor cells that differentiate into osteoblasts
and osteoclasts in the process of osteogenesis or bone
formation.
Osteoblasts secrete large quantities of ALP when they
are actively forming/depositing bone matrix. ALP is
believed either to increase the local concentration
of inorganic phosphate or to activate the collagen fibers
in such a way that they cause deposition of calcium
salts into the bone matrix (osteoid). Since some ALP
diffuses into the blood during this process, the blood
level of ALP is usually a good indication of bone formation
and is one of the marker tests to evaluate osteoporosis.
Coix seeds are included in the formulation for their ability
to lower blood sugar and counteract inflammation and fibrosis
formation.
1. Osteoporosis: Prevention, Diagnosis
and Management, 3rd Edition, Morris Notelovitz, MD, PhD,
Professional Communications, Inc., 1999.
2. Treatment of Avascular Necrosis of the Femoral Head
with Chinese Herbs, by Subhuti Dharmananda, PhD, Director,
Institute for Traditional Medicine, Portland, Oregon,
www.itmonline.org published December, 2003.
3. Guytons Physiology Text
4. www.nof.com – National Osteoporosis Foundation
website.
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