A number of patients have recently told me their primary care doctors started them on Fosamax for “pre-osteoporosis” a condition less severe than full blown osteoporosis, also called “osteopenia”. This is a very bad idea with two problems.
The Fosamax (Alendronate) medical study for FDA approval failed to show any benefit for the osteopenia group. Fracture rates actually went up for the osteopenia group. This data was published by Cummings in JAMA in 1998, (the FIT study, which stands for Fracture Intervention Trial).
The FIT data revealed that Fosamax (Alendronate) doubled the risk of hip fractures in women with a femoral neck T score greater than -2.5. There were 6 hip fractures (0.4%) in the placebo group vs. 11 fractures (0.8%) in the Fosamax group.
Bisphosphonates drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous femur fracture, atrial fibrillation (a heart rhythm disturbance), and severe bone and joint pain. Another common adverse effect is oesophageal erosion, heartburn and oesophageal reflux.
A few definitions: Osteoporosis is defined as a DEXA T-Score of minus 2.5 to minus 3.5. Pre-osteoporosis is defined as a DEXA T-Score of minus 2.0 to minus 2.5.
Fosamax, A Bad Drug in Litigation
One of the early warning signs of a bad drug is ongoing drug litigation for adverse side effects. This calls the drug into question as a “BAD DRUG”.
Fosamax drug litigation began in Aug 2009 against Merck by plaintiff, Shirley Boles, age 71, who suffered ONJ (osteonecrosis of the jaw) allegedly from Fosamax. OJN, osteonecrosis of the jaw, is a well-known adverse side effect of Fosamax, which has been heavily documented in the dental and oral surgery medical literature. Merck faces an onslaught of more than 900 cases awaiting litigation.
Spontaneous Femur Fracture Induced by Fosamax
Another warning sign of a BAD DRUG is spontaneous femur fractures (with no trauma) that occur in women on Fosamax. A number of these embarrassing reports have appeared in the New England Journal of Medicine and the Orthopaedic Surgery medical literature.
FDA Warning of Fosamax Induced Bone and Joint Pain
Another sign of a BAD DRUG is an FDA Warning letter. Physicians received such a warning letter telling then about severe, incapacitating bone and joint pain caused by Fosamax. What causes this? No answer there. I would suggest multiple micro-fractures as the cause for the severe bone pain.
Consumer Complaints Against Fosamax
Another warning sign of a bad drug is the number of consumer complaints on message boards, which can be seen by anyone with an internet connection.
Why is Fosamax a BAD Drug ?
There is no question that follow up DEXA BONE SCANS show improving bone density on Fosamax. So why is this a bad drug?
The answer is this increased bone density is cosmetic and does not equate with stronger bone. Simply put, the drug creates pathologic bone that is weak and brittle. The Fosamax treated bone is actually more prone to spontaneous fracture and necrosis, not less so. The drug actually does the reverse of what it is intended for.
Reverse Osteoporosis Naturally
Rather than use a bad drug like Fosamax, a far better solution for reversing osteoporosis is a combined program of lifestyle modification, diet, nutrition, exercise and bio-identical hormone supplementation.
1) Modify diet to an alkaline diet that halts calcium loss as a buffering agent for acid excretion. Use home pH testing to determine success.
2) Nutritional supplement with high quality calcium product containing bioavailable calcium, magnesium, boron, strontium, and Vitamin K.
3) Test for and optimize Vitamin D and Magnesium levels.
4) Regular Weight bearing exercise program as tolerated.
5) Test for and optimize hormone levels for estradiol, progesterone, testosterone, and DHEA.