Osteoporosis drug Forteo linked with bone cancer

BLACK BOX WARNING FOR FORTEO, a gentically engineered pharmaceutical

POTENTIAL RISK OF OSTEOSARCOMA: In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. The effect was observed at systemic exposures to teriparatide ranging from 3 to 60 times the exposure in humans given a 20-mcg dose. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe FORTEO® only for patients for whom the potential benefits are considered to outweigh the potential risk. FORTEO should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton)

Forteo, the drug that was found to cause a rare, serious bone cancer (osteosarcoma) in rodents, but drug proponents suggested such cancers would not occur in humans. But this week, there have been three reported cases of this rare bone cancer developing in people taking Forteo.

The most recent case was detailed in an abstract (# SU0345) presented at the annual meeting of the American Society for Bone Mineral Research in Denver, from which I just returned. This is the third case in the recent literature. The first case of osteosarcoma associated with Forteo use was published in the Journal of Bone Mineral Research in 2007 (JBMR vol. 22, p. 334), and a second case was published on-line in Osteoporosis International on the 14th of July, 2009.
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What you can do to protect your bones-
It is a myth that calcium is the cure for prevention. The best prevention is regular weight-bearing exercise, an increased intake of vitamin D-3 (at least 2,000 IU a day, more if you live in northern latitudes and are a person of color or someone who does not go in the sun), vitamins K and C, magnesium, and a high intake of vegetables (especially leafy green and yellow vegetables). A study reported in the American Journal of Clinical Nutrition found that the best preventative against osteoporosis is a high intake of vegetables, both because of the high potassium content and the fact that a number of flavonoids in vegetables directly prevent calcium loss. In addition, avoiding a high intake of red meats is also essential.

Bone Health Testing - Better than DEXA and no radiation exposure
Bone Density Measurements: Most people think of bone density studies as involving special x-ray machines. In fact, better measurements can be obtained from blood tests. One of the best involves measurements of pyridinium crosslinks and deoxypridinoline (DPD).

Pyridinium is a substance found in both bone and cartilage and deoxypyridinoline is found predominantly in bone. High levels of DPD indicate osteoporosis when other bone disorders are not present.

Pyridinium is elevated in a number of conditions including osteoporosis, rheumatoid arthritis, osteoarthritis and chronic alcohol abuse. These tests are very valuable in following responses to treatments.

And when getting annual physicals, make sure to request a Phosphorus level so you can determine the Calcium-Phosphorus ratio. Years ago Phosphorus was removed from the metabolic panel by Medicare because they believed it to be a cost cutting measure and an unnecessary test.

You might also consider testing for vitamin D (25 OH test) and parathyroid hormone.

Thank you to Susan Brown PhD and Russell Blaylock MD for sharing some of the information in this post.

Bone Loss Problematic, Bone Drugs Risky

In January 2008 the FDA issued warnings regarding the class of drugs developed to allegedly help people with osteopenia and osteoporosis.

Numerous problems are associated with these drugs, including bone frailty and increased fracture rates.

Now chemotherapy for cancer seems to be opening a new window to ply these drugs on patients who already are health compromised because of the cancer and chemotherapy drug treatments.

It is interesting to note that there does exist a safe and effective approach to maintaining storng, healthy and flexible bones with vitamins and other natural supplements.

Some other physicians express concern -"

Bisphosphonates, like Fosamax and Actonel, are taken up by osteoclasts with resulting loss of osteoclast activity and inhibition of bone resorption, and bone remodeling (link). Although DEXA scanning confirms increased bone density and studies such as the FIT suggest reduced fracture rate, Susan Ott, MD raises questions about the long term safety of bisphosphonates. Although the bisphosphonates appear to have short term benefits, she speculates that after 5 years of use, there is severe suppression of bone formation with negative effects such as microdamage and brittleness.

Jennifer P. Schneider, MD, PhD reports a 59-year old previously healthy woman on long-term alendronate. While on a subway train in New York City one morning, the train jolted, and the woman shifted all her weight to one leg, felt a bone snap, and fell to the floor, suffering a spontaneous mid -femur fracture (see image). In the months following, it became clear that the fracture was not uniting. Schneider speculates that increased bone density from the bisphosphonate drug does not necessarily equate with good bone quality. By decreasing osteoclast activity and bone resorption, and therefore bone formation as well, microdamage, and brittle bone may result in fractures.

Odvina reports on 9 cases of spontanous fracture while on alendonate. Five of the nine cases were spontaneous mid femur fractures. Two had bilateral mid femur fractures same as Toulouse Lautrec. Six cases had delayed or absent fracture healing. Histomorphometric analysis of the cancellous bone showed markedly suppressed bone formation, and Odvina raised the possibility that severe suppression of bone turnover could develop during long-term alendronate therapy, resulting in increased susceptibility to, and delayed healing of, nonspinal fractures.

Dimitrakopoulos reports on 11 patients presenting with necrosis of the jaw, claiming this to be a new complication of bisphosphonate therapy administration, i.e. osteonecrosis of jaws. He advised clinicians to reconsider the merits of the rampant use of bisphosphonates. Osteonecrosis of the jaw is a common finding in pycnodysostosis. The bisphosphonates recreate the same clinical p rofile of spontaneous mid femur fractures, failure of bone healing and jaw necrosis which tormented Toulouse Lautrec.

In spite of this well known information, there are four more drugs in clinical trials which are specifically designed to inhibit cathepsin K, the enzyme defect in Lautrec's genetic bone disease. FDA approval for use in osteoporosis treatment is expected. Excuse me here, but perhaps this thinking needs re-evaluation. In essence we are creating a population of women with Toulouse Lautrec's bone disease. Ironically, women who sustain fractures while on Fosamax are told by their docs that the fractures are due to the underlying osteoporosis, not the drug. "

Cancer Treatment May Result In Bone Loss, Study Finds

ScienceDaily (2008-11-17) -- A new cross-Canada study has found that breast and prostate cancer treatment can foster bone loss. Scientists explain how loss of bone mass might affect 46,000 people diagnosed with breast and prostate cancer each year and place them at increased risk for osteoporosis and fractures. ... > read full article

FDA Issues Alert on Bone Drugs
By Elizabeth Trotta
The FDA posted an alert on Monday regarding possible severe, sometimes incapacitating bone, joint, and/or muscle pain in patients taking a class of bone-density drugs called bisphosphonates.
The possibility of such pain is listed in the drugs' prescribing information, but the FDA warned that doctors may overlook it to the point that it's prolonged or results in impairment, possibly requiring analgesics. This pain can occur days, months or years after initial use, and the risk factors for and incidence of severe musculoskeletal pain associated with the class are still unknown, according to the agency.

"Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug," noted the health regulator in a Med Watch post on Monday.

The class of bone drugs in question include:

Proctor & Gamble's(PG Quote - Cramer on PG - Stock Picks) Actonel, Actonel +Ca, and Didronel

Novartis'(NVS Quote - Cramer on NVS - Stock Picks) Aredia, Reclast and Zometa

Roche and GlaxoSmithKline's(GSK Quote - Cramer on GSK - Stock Picks) Boniva

Merck's(MRK Quote - Cramer on MRK - Stock Picks) Foxamax, Fosamax + D

Sanofi Aventis'(SNY Quote - Cramer on SNY - Stock Picks) Skelid.

Drug companies downplay risks of bone-strengthening drugs for women
18.01.2008 Source: URL: http://english.pravda.ru/science/103518-bone_strengthening_drugs -0

Drug companies exaggerate the benefits and downplay the risks of prescribing bone-strengthening drugs for women whose bones are weakened but who do not have osteoporosis, a new report claims.

Drugs such as alendronate and risedronate do reduce the risk of fractures of women with osteoporosis, according to the article in the Jan. 19 issue of BMJ.

Alendronate is a bisphosphonate drug used for osteoporosis and several other bone diseases. It is marketed alone as well as in combination with vitamin D (2,800 U and 5600 U, under the name Fosamax+D). Merck's U.S. patent on alendronate is set to expire in 2008 and Merck has lost a series of appeals to block a generic version of the drug from being certified by the U.S. Food and Drug Administration.

Risedronate sodium is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget's disease of bone. It is produced and marketed by Procter & Gamble and Sanofi-Aventis.

In January 2006 P&G and its marketing partner Sanofi-Aventis filed a Lanham Act false claims lawsuit against rival drugmakers Roche and GlaxoSmithKline claiming false advertising about Boniva. The manufacturers of Boniva, a rival bisphosphonate, were accused in the suit of causing a "serious public health risk" through misrepresentation of scientific findings. In a ruling on on September 7 2006 U.S. District Judge Paul A. Crotty rejected P&G's attempted injunction. P&G was criticized for attempting to "preserve its market share by denigrating Boniva". Judge Crotty wrote that "Roche was clearly entitled to respond with its own data, provided that the data was truthfully and accurately presented".

Source: «PRAVDA.Ru».