as this column has previously discussed, osteoporosis fracture prevention requires nothing but a sensible lifestyle plus sensible lowcost permanent cocktail of natural supplements that reverse all chronic degenerative diseases- eg calmag, boron, zinc, manganese; vits B C D & K, proline, and lowdose appropriate HRT. Better late than never, but the earlier started the better.
The heavily marketed commercial moneyspinners- bisphosphonates BNPs; strontium ranelate; calcitonin, parathormone, SERMs eg raloxifene; tibolone; and statins – each have significant risks and costs, and none give the multisystem protection of the scores of evidence-based natural supplements.
The reviews and trials of bisphosphonates the last year are especially alarming for zoledronic acid (ZA Reclast / Zometa)
Today’s FDA (Grewal) last month reports that ZA and Aredia give an osteonecrosis (O.N) risk of about 1:10 000 patients; alendronate a risk of 0.7/ 100 000 patient years.
this year Italy (Ibrahim) reports an incidence of 1.5% ONJ in 500 cancer patients over 4yrs- and all those patients were treated with ZA.
Harvard Dental School (Wessel) this year reports 30 cases of O.N of the jaw ONJ over 4 years – all on ZA.
But Univ Arizona (Hess) this year reports 99 cases of ONJ after bisphos in patients without cancer- 85 for OP, 10 for Pagets. 87% were women and 83% had oral not iv BNP.
The international HORIZON Z.A.osteoporosis trials last year reported 1 case of O.N in each 2500 arm of trialists on ZA or placebo (mean 74yrs (65-85yrs) treated with annual ZA versus placebo injection; there was 35% reduction in fracture rate at mean followup 1.9years in those enrolled after hip fracture ie tertiary prevention ;
and 70% fewer fractures at 3yrs in women enrolled with osteoporosis.- secondary prevention (ZA 1.1%pa, placebo 3.6%pa).
There was however no significant difference in major adverse events or non-fracture deaths (the causes of death of the majority. were not reported). However, serious atrial fibrillation was 3 times more common in the month after ZA than after placebo. By 1.9yrs after the hip fracture and starting ZA there were fewer deaths on ZA 4.5%pa than placebo 6.7%; but in the slightly younger and fitter majority ie those without prior hip fracture, by 3 yrs, there were 16% more deaths on ZA (1.13%pa%) than placebo(0.97%pa%).
These 2007 Horizon trials thus highlight that delaying prevention till the hip collapses more than trebles the deathrate .
What they mysteriously neglect to report is the quality of life, mobility after major osteoporotic fracture- when it is common cause that waiting for major disease before starting prevention is disastrous- sudden death, stroke, dementia; or that at best 20% of patients recover full health and mobility after hip fracture.
However, (as usual with commercially sponsored trials to promote a new drug – ie seeding trials) baseline conventionally proven natural therapies were severely limited, probably to falsely exaggerate the benefit of the trial drug: so (while almost half were apparently on raloxifene), all including the placebo arm were given a baseline regime only of vitamin D and modest dose calcium.
The Sponsors thus chose to ignore the longstanding evidence from major studies and trials – that no designer drugs are needed to reduce both osteoporotic fractures and most all-cause aging diseases: – merely appropriate supplement/ replacement with, calcium, magnesium, zinc, boron, manganese, all 13 vitamins and the biologicals ( proline, lowdose appropriate sexhormones, fish oil – and for other multisystem protection, eg arginine, carnitine, CoQ10, glucosamine, chondroitin, MSM etc.).
While it is common cause that quality of life QOL is greatly improved by appropriate HRT in the menopause transition- the midlife decade of menopause symptoms ,
longterm QOL outcome is conveniently not mentioned in any bisphosphonate papers that span the progressively more risky decades after the midsixties – although this QOL attribute for ZA is a main goal that Novartis mentions in it’s registration motivation ” The unique once-yearly dosing of this medicine has the potential for significant compliance benefits and improved quality of life for women with osteoporosis.”
Despite the fact that trials of bisphosphonates for osteoporosis started over 20 years ago, no such claim of improved mobility and QOL long term is made, so there cannot have been any significant improvement shown. There are exactly two small trials, from Italy and Turkey, that lasted one year looking at QOL, that showed improvement in QOL on (alendronate or nerindronate or calcitonin) plus calcium/vit D versus calcium/vit D alone. Short term study- one year – says nothing about the average 35yrs of life expectancy after the perimenopausal midlife decade. .
The bisphosphonate trials also blithely omit that the top risk factor for osteoporotic fractures is not bone density but overall physical – frailty, falls; and while major fractures are common in the old, they dont happen,if the patient dies early, or they matter little if the patient is first disabled (before fracturing) by far more common cardiovascular-stroke problems or dementia.
Nobody can claim, show that bisphosphonates, SERMS, tibolone, calcitonin, strontium have any significant long term benefit on overall premature major diseases of aging and mortality. Unlike appropriate HRT, or fish oil, or metformin, or vigorous other combination of natural supplements (vitamins, minerals and biologicals including herbs) , no modern chronic designer patent drug for chronic prevention has been shown to significantly reduce all-cause morbidity and mortality – especially diabetes, CVD-stroke, osteoarthritis, fractures, major depression and dementia. .
So there is no justification or need to take bisphosphonates or any other newer patent drugs for osteoporosis – and why take the risk of bisphosphonate arrhythmia, toxicoderma or osteonecrosis?