October 20, 2005
U. S. Foods & Pharmaceuticals, Inc.
313 West Beltline Highway, Suite 184
Madison, WI 53713
I am presently working on a project investigating the effects of OstiGen on NTx values in urine. NTx is molecule found in urine that is an accurate predictor for measurement of bone loss. As you are aware, I am a general surgeon caring for a broad range of patients. My interest in OstiGen was piqued as a potentially effective product to substitute for estrogen as an aid to manage osteoporosis. Most of the patients recruited for this study had breast conditions coinciding with their use of estrogen; others had hyperparathyroidism, a known risk factor for osteoporosis. In the patients with pre-malignant or malignant breast conditions, it was my duty to counsel them against estrogen replacement therapy (ERT). Without an alternative therapy to prevent bone loss, these women were at risk for the onset of osteopenia and osteoporosis (bone loss conditions).
In my study, I ordered NTx assays at the baseline, which I defined as the “pre-OstiGen value.” I then placed the patients on OstiGen. After one month of taking OstiGen, at one dose three times per day (350 mgs of calcium per dose) the NTx assay was repeated and study values were compared to the baseline.
The following is a summary of my preliminary results:
All assays were performed by LabCorp.
- The values we received were expressed as nMBCE/mM CR.
- 17 people were recruited for the study, 12 people have completed the study.
- Of the five study members with incomplete data, three refused to return for comparative assays, one experienced stomach cramps and was unwilling to continue. One is still completing the study and has not had a follow-up interview.
- Of the twelve participants that returned for follow-up, all demonstrated decreases in the NTx measured. The results were expressed as “post-OstiGen NTx / pre-OstiGen NTx.” Results less than 1 demonstrated an improvement in the NTx score. The average reduction in NTx in this study was 0.553.
The magnitude of the decrease in the NTx score is proportional to the risk of bone fractures associated with osteoporosis. The presence of NTx molecules in healthy persons is normal at values under 18. Anyone with a baseline NTx of 51-67 is 3.8 times more at risk for broken bones due to bone density loss. By comparison, a person with a baseline of 67-188 is 17.3 times more at risk. The application of an NTx score of 51 as a cut off was used, as it is the value used by LabCorp in their expression of a statistically significant high “probability of decrease in BMD (bone mineral density).”
The results of this study show that patients with NTx scores greater than 51 improved when compared to baselines with an average reduction of 0.443. Additionally, patients with NTx scores less than 51 experienced an average reduction of 0.666. These numbers show that patients with bone density loss at greatest risk for fracture experienced the most significant reduction in risk during the study.
In summary, those patients who have taken OstiGen have experienced the following results:
- All patients experienced a reduction in the risk factors for bone loss and fractures.
- All patients' urine NTx values dropped during this study.
- Patients with greatest bone density loss experienced the most significant recovery during this study.
It should be noted that this research is ongoing and results will continue to be monitored. The expectation is that ongoing results will show continued reduction of bone loss while OstiGen is being consumed.
Based on the preliminary results of this study, I will continue to recommend OstiGen to patients who have bone loss conditions or need to suspend ERT. I would also recommend this product to other physicians for use with their patients.
Please feel free to contact me for any questions you may have.
Mario Cerame, M.D. FACS
October 20, 2005
Manager, Strategic Accounts
726 Heartland Trail
Madison, WI 53717
I am a family physician in Newport News, Virginia, and have been treating patients at risk for bone loss and osteoporosis with OstiGen, a new product from U. S. Foods & Pharmaceuticals, Inc. I have been assessing patients' bone health with the Achilles Insight Ultrasound (QUS) densitometer by GE Medical since August of 2004. These bone health tests have been used to establish baseline bone density readings as well as follow through testing for monitoring improvement in bone health.
Patients who had initial T-scores (a standard measurement of bone mass density) in the osteopenic or osteoporotic range have been further tested, using DEXA scans at a nearby hospital to confirm the readings, and further diagnose the individual patient condition.
I have placed these patients on OstiGen, which has been identified to help build bone mass and slow down bone loss. My patients have reported no serious side effects and have indicated a positive acceptance for the taste and flavor of OstiGen.
I have followed these patients with a repeat ultrasound and DEXA, and have attached the results herewith for your review. As you can see, the results are remarkable and far exceed any other available therapies in use. I have seen an average improvement in patient bone density of at least 10% from this group of patients.
This far exceeds my expectations and indicates that OstiGen plays a vital role in improving bone density scores by comparison to other available therapies.
I would be most encouraged to see other physicians follow this lead and use the OstiGen Bone Health Program in their practices, as I feel it would be of significant benefit to their patients.
Frank H. Huffman, M.D.
Riverside Commonwealth Family Practice
September 12, 2005
US Foods & Pharmaceuticals, Inc
313 W. Beltline Highway
Madison, WI 53713
I am writing to thank you for encouraging me to begin taking Ostigen. As I mentioned when we met, I have severe osteoporosis. Bone density tests put me in the highest risk category. I have the bones of an 80-90 year old. (I am tiny and small boned (110 pounds) and have been unable to bare weight for 20 years due to the effects of multiple sclerosis. In addition to that, I was on a daily dose of prednisone for nearly 15 years.)
At your suggestion, I discussed taking Ostigen with my gynecologist, Eric Wait. Dr. Wait had no objection to adding Ostigen to the Fosamax I was taking to treat my osteoporosis. At that time, I had been taking Fosamax for approximately 8 years with minimal improvement.
I began taking the Ostigen powder in September, 2004. In March, 2005, the results of the NTX test came back and Dr. Wait told me that I was "making good improvement." And, to "keep doing what you’re doing. It’s working!"
I know that my bones are still at risk for fractures because of years of bone loss. However, I now feel I’ve got a better chance to improve my condition and will continue to take OSTIGEN.
Thank you for your work, your tenacity, and for bringing Ostigen to the market. I am deeply grateful to you and all the people associated with US Foods and Pharmaceuticals.
S. P. Schwarz
December 13, 2005
U.S. Foods & Pharmaceuticals
313 West Beltline Highway
Madison, WI 53713
Thank you for introducing me to your bone health supplement, OstiGen. It has improved my bone health measurably and I encourage you to continue reaching out and changing the minds of physicians who, like mine, believe in treating bone disease rather than preventing the disease from occurring.
I am an active woman in excellent health. Several years ago when I was thrown from my horse and broke my arm I healed quickly. I mistakenly believed that my quick recovery coupled with the lack of bone health consultation from my doctor meant that my bones were healthy and that I was not suffering bone loss. When in fact, my bones were thinning.
In 2003 I became an investor in your company and began learning more about bone health and disease prevention. I didn’t know at the time, but my bone density T-score at the lumbar spine was -1.3. While this score does not indicate osteoporosis, it does indicate the early stages of osteopenia –a precursor to osteoporosis. Because I did not yet have the disease, my physician didn’t consult with me about my T-score or my bone health.
I am thrilled to report that after taking OstiGen for two years, my lumbar T-score has improved to –0.59. This increase means that my bones are no longer in the osteopenia range and my bone health is in the 99th percentile compared to other women my age. The fact that my T-score at the femoral neck site remains constant (-1.3 in 2003 and –1.29 in 2005) instead of worsening is also a testament to the efficacy of OstiGen.
As women age we naturally lose bone mass. The advantage "An ounce of prevention is worth a pound of cure" has special meaning to me and the other 44 million Americans at risk of osteoporosis. Thank you for your efforts to educate as many of us as you can about preventing this disease.