HORIZON-PFT Study 2301 Slide Library V3 1-May-07 CONFIDENTIAL HORIZON-PFT Slide Library - Osteoporosis: Summary The hallmark of osteoporosis is microarchitectural degeneration of bone tissue 1,2 The rate of bone resorption exceeds the rate of bone formation in older adults, particularly in postmenopausal women Osteoporosis results from this imbalance between bone resorption and formation Bone mass is lost, density is reduced, and bones become fragile, thin and brittle In the year 2000, there were an estimated 9.0 million osteoporotic fractures of which 1.4 million were clinical vertebral fractures, 1.6 million were at the hip, and 1.7 million at the forearm 3 The majority of these osteoporotic fractures occurred in Europe (34.8% of the total) 4 Osteoporosis is a major public health threat with serious clinical consequences. The disease places a significant burden on society in terms of public health, healthcare resources, direct medical costs such as surgical procedures, and indirect medical costs such as lost productivity 5–8 Of the many available treatments for osteoporosis, bisphosphonates are the choice for first-line therapy in most countries worldwide References Eastell R. Treatment of postmenopausal osteoporosis. N Engl J Med . 1998;338:737–746. Follin SL, Hansen LB. Current approaches to the prevention and treatment of postmenopausal osteoporosis. Am J Health Syst Pharm . 2003;60:883–901. Inter national Osteoporosis Foundation (IOF). Available at: http://www.iofbonehealth.org/iof-articles/article-detail.html?articleID=27. Accessed 21 May 2008. International Osteoporosis Foundation (IOF). Available at: http://www.iofbonehealth.org/policy-advocacy/europe.html. Accessed 21 May 2008. National Osteoporosis Foundation. Fast Facts on Osteoporosis. Available at: http://www.nof.org/osteoporosis/diseasefacts.htm. Accessed 23 May 2008. International Osteoporosis Foundation (IOF). Available at: http://www.iofbonehealth.org/facts-and-statistics.html. Accessed 23 May 2008. Delmas PD, van de Langerijt L, Watts NB, for the IMPACT Study Group. Underdiagnosis of vertebral fractures is a worldwide problem: the IMPACT study. J Bone Miner Res . 2005;20:557–563. Burge R, Dawson-Hughes B, Solomon DH, et al. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005–2025. J Bone Miner Res . 2007;22:465–475.
Richard v W, Achala & Jaime from Singapore Fellow colleagues from NVR M’sia Appreciate your presents to review the LRR together (Aik Hwa- to do the introduction)
Zoledronic Acid Reduced 3-Year Risk of Vertebral Fractures (by Geographic Region) ZOL 5 mg produced significant reductions in vertebral fracture risk in patients in all geographic regions studied (54% to 84% reduction). Because there were a small number of events and confidence intervals wide one can not draw conclusions about the staistical significance, however, the general trends reflect the primary efficacy results. Within-subgroup P-values are based on logistic regression with treatment, baseline fracture status in the model using log-likelihood type approach. Reference Cauley J, Black D, Boonen S, et al. Effect of zoledronic acid (ZOL) 5 mg on fracture risk by age and geographic region in women with postmenopausal osteoporosis: results from HORIZON-PFT [abstract]. Osteoporos Int . 2007;18(suppl 1):S26. Abstract OC53.
Mean Serum β-CTX Over Time Reductions in serum β-CTX levels over time were similar to those observed for urine NTX, with zoledronic acid resulting in significantly greater reductions in serum β-CTX levels at all postbaseline time points compared with alendronate. At Week 24, mean β-CTX was within the premenopausal reference range (0.117 – 0.606 ng/mL [Synarc, Lyon, France]) in the alendronate group and slightly below the reference range in the zoledronic acid group (mean 0.114, SE = 0.011). Reference Saag K, Lindsay R, Kriegman A, Beamer E, Zhou W. A single zoledronic acid infusion reduces bone resorption markers more rapidly than weekly oral alendronate in postmenopausal women with low bone mineral density. Bone . 2007;40:1238-1243.
Summary Switching patients who had been treated with oral alendronate 70 mg for an average of 4 years to a single dose of IV zoledronic acid 5 mg resulted in persistence of the inhibition of bone remodeling and stability of BMD in a very similar range as if they had remained on alendronate therapy. The switch from oral to IV therapy was well tolerated, and the overall frequency of AEs was comparable in both groups. The majority of patients in both treatment groups expressed preference for once yearly infusion over weekly oral therapy. An annual infusion would ensure adherence for a full 12 months, and the maintenance of BMD seen 12 months after a single infusion of zoledronic acid 5 mg supports its use in women who have previously been treated with oral alendronate. Reference McClung M, Recker R, Miller P, et al. Intravenous zoledronic acid 5 mg in the treatment of postmenopausal women with low bone density previously treated with alendronate. Bone . 2007;41:122-128.
Dr Ling Sien Ngan Anti Aging, Aesthetic Medical Practitioner
<ul><li>9 million peoples suffered osteoporosis fracture annually world wide, majority died soon after due not to fracture, but complication </li></ul>
<ul><li>Have you taken any prevention ? </li></ul>
Bone Health Dr Ling Sien Ngan Anti Aging, Aesthetic Medical Practitioner
Anti Aging & Aesthetic medical practitioner 1. Anti Aging medicine 2. Men’s health & Andrology 5. Cosmetic surgery 4. Cosmetic Dermatology 3. Holistic complimentary medicine Aesthetic / External Anti aging
Anti aging medicine <ul><li>Balanced diet </li></ul><ul><li>Nutritional supplementations + antioxidants </li></ul><ul><li>Detoxification ( chelation, colon hydrotherapy, FIR sauna, ozoniser okamizu </li></ul><ul><li>Correct, moderate exercise. </li></ul><ul><li>Weight management </li></ul><ul><li>Syndrome X + Mx of chronic deg dse -CDD </li></ul><ul><li>Osteoporosis </li></ul><ul><li>Bio-identical hormones </li></ul><ul><li>Occupational health noise , chemical </li></ul><ul><li>Stress Mx: relaxation meditation , yoga </li></ul>
vs Wellness Industry Sickness Industry Anti Aging Medicine is Even here can still anti age !
How to Administer Aclasta A Simple Step-by-Step Guide <ul><li>Pre infusion instructions </li></ul><ul><li>(before patient’s infusion appointment) </li></ul><ul><li>Measure serum creatinine and confirm creatinine clearance >40 ml/min1. </li></ul><ul><li>Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D. </li></ul><ul><li>Patients can eat and drink normally before the infusion. They should drink at least 2 glasses of fluid, such as water, to ensure adequate hydration at the time of infusion. </li></ul>Please refer to full prescribing information before prescribing Aclasta Prescribing Information May 2008
15 minutes infusion yr long protection <ul><li>Aclasta ® bypasses the GI tract, </li></ul><ul><li>Eliminating absorption limitations associated with oral bisphosphonates </li></ul>39% Eliminated From circulation within 24 hours 2 61% Binds directly to bone tissue 2 100% Bioavailable 2 vs. less than 1% with oral bisphosphonates 3-6
Instruction for post dose admin <ul><li>Adequate calcium and vitamin D intake </li></ul><ul><li>potential adverse events </li></ul><ul><ul><li>most common transient symptoms fever, myalgia, flu-like illness, headache, and arthralgia. </li></ul></ul><ul><ul><li>The majority occurred within 3 days of infusion, were mild to moderate, and resolved within 3 days of onset </li></ul></ul><ul><ul><li>Monitoring: </li></ul></ul><ul><ul><li>BMD : Yearly </li></ul></ul><ul><ul><li>Serum BTx </li></ul></ul><ul><ul><li>Urine NTX </li></ul></ul>
Mdm S , 46yr <ul><li>lean , fair, female </li></ul><ul><li>Family Hx , father low trauma fracture on fall </li></ul><ul><li>Well motivated, </li></ul><ul><li>already on Forsamax, oral, weekly </li></ul><ul><li>Beta crossLab high, pre Rx ( osteoclast ) </li></ul><ul><li>Post infusion, drop by half </li></ul><ul><li>No more cold hand, stiff join </li></ul><ul><li>Brought 2 more sister </li></ul>
Mdm Thiong, 85 yr <ul><li>In-law’s neighbor </li></ul><ul><li>Fully healthy </li></ul><ul><li>Fell 3 yrs back fracture neck femur </li></ul><ul><li>Dr refused hip replacement </li></ul><ul><li>Pt wheel chair bound further Ca lost accelerated on non use < immunity, </li></ul><ul><li>die of other complications few months ago </li></ul><ul><li>Illustrate important of prevention as insurance she would have lived longer </li></ul>
Cost advantages of Aclasta <ul><li>Max 3 Rx </li></ul><ul><li>Others need to continue mostly life long costlier in long run, e.g. fosamax, 1 yr = $1400, </li></ul><ul><li>10yr = 14K </li></ul>
Summary <ul><li>Safely switched from oral weekly alendronate, Fosamax, to once-yearly ZOL 5 mg with maintenance of BMD for at least 12 months </li></ul><ul><li>Switch from oral to IV well tolerated </li></ul><ul><li>Most prefer yearly infusion to weekly oral </li></ul>
Be all that you are Show it off <ul><li>VIBRANT </li></ul><ul><li>RADIANT </li></ul><ul><li>VITALITY </li></ul>Thank you