Forteo did nothing for me.  My dr. recommended it to me when I had -3.04 T score for my spine.  After injecting for 18 months, my bone density last week showed a new T score of -3.0.  Needless to say the results were certainly discouraging.

I am wondering if I am an exception or if this drug does anyone any good?

My question to the lady who took Forteo for 19months did they find out you Tscorte by a blood test or by dexa scan or by the new method of getting ones real tscores by catscan??????  Your doctor should of been taking blood 3,6,9,months and so and try the ctscan is so much more on the spot than old Dexa scan. 

Casey--Just want to make sure you know/talk about the serious health concerns related to Forteo: studies in humans were stopped because of the very high incidence of bone cancer in rats who were put on Forteo.  Moreover, human tests were only conducted for less than two years. 

The following is from Dr. Susan E. Brown:

The new osteoporosis drug Forteo^TM (teriparatide) is receiving a lot of attention these days, and many women are wondering if it's a safe treatment option for them. Approved by the FDA in 2001, Forteo works to increase new bone formation instead of halting bone breakdown like some osteoporosis drug therapies, including Fosamax, Actonel, Boniva, or even estrogen. This means women who take Forteo are actually building new bone, instead of simply preventing its degeneration.

Forteo has attracted a lot of attention because of the research showing increases in lumbar spine bone density, hip density, and the significant reductions in fracture incidence. But if you're thinking this sounds too good to be true, you might be right. Unfortunately, the benefits of Forteo, like most pharmaceutical drugs, do come at a cost. Forteo is not only very expensive, but animal studies have shown links to bone cancer. In fact, studies on humans were stopped two years after they were started because of safety concerns.

Let's take a closer look at this new osteoporosis drug treatment so you can make an informed decision about Forteo and your bone health.

What is Forteo, and how does it work for my bones?

Forteo is a synthetic replica of a hormone we make in our bodies called parathyroid hormone (PTH). It's formulated using bacterial cultures (E. coli) with an amino acid sequence identical to part of the human parathyroid hormone (PTH).

In the body, natural parathyroid hormone serves to regulate bone metabolism. Through activation of various bone metabolic pathways, the PTH drug (Forteo) increases the number of active osteoblasts (bone-building cells), possibly stimulating them to overactivity. As I mentioned above, this can certainly increase bone density.

Here's what the research shows:

• In a 19-month study of high-risk osteoporotic women, Forteo increased bone density by an average 9.7% in the spine and 2.6% in total hip, while the wrist lost bone density and total body mineral content remained the same.
• Among 1,637 postmenopausal women with severe osteoporosis and one or more vertebral fractures at baseline, the drug produced a 9.3% absolute fracture risk reduction over 19 months.
• Over 19 months in these same high-risk women, Forteo reduced hip, pelvis, wrist, rib, humerus, and other fractures by an absolute 2.9%.

Overall, the short-term studies of Forteo for osteoporosis treatment and bone loss reported above show this drug to reduce fracture risk substantially more than the bisphosphonate drugs like Fosamax. In these studies, Forteo also increased bone density more than the bisphosphonates.

Is Forteo safe for you?

Though Forteo may appear to be a good approach to building bone, there are some major questions regarding safety. In fact, safety studies done on rats have shown findings of excessive new bone formation as well as bone cancer. Not surprisingly, the cancer this drug was found to cause in rat studies (osteosarcoma) is a malignancy often associated with high osteoblast activity and rapid bone growth.

Another key point is that the longest studies of Forteo were only two years in duration. Why are there only short-term studies on this new drug treatment? Because in the animal safety studies, Forteo was shown to cause a very high incidence of osteosarcoma, as well as osteoblastoma (abnormal mass of tissue in bone), and osteoma (small, benign bone lesions). Even though the drug doses tested were from 3-, 20-, and at times, 60-fold higher than those used in human medications, malignant bone tumors were observed at all Forteo doses, with the incidence reaching 40-50% in the higher-dose groups.

Given this major safety concern, human trials with this osteoporosis drug treatment were terminated early, and guidelines were set to limit the duration of its use in humans. In fact, as the manufacturer specifically states, "The safety and efficacy of Forteo have not been evaluated beyond 2 years (median 19 months in women and 10 months in men). Consequently, the maximum lifetime exposure to Forteo for an individual patient is 18 months." The drug was only approved for treatment of osteoporosis in 2003, so there are no data, in animals or humans, as to whether use of the drug contributes to longer-term cancer risk.

Additionally, the FDA now requires a "black box" label warning clearly stating the increased cancer risk shown in rat studies. This warning also makes clear that the following individuals should not take Forteo: those with an increased risk for osteosarcoma, which includes patients with Paget's disease of bone, those with unexplained elevations of phosphatase, open epiphyses, or prior external beam or implant radiation on the skeleton.

A short-term solution with a big price tag

Forteo is certainly not a magic bullet for bone loss and osteoporosis. I would say it is more like a drug of last resort. Aside from the cancer risk, there are several other considerations to keep in mind if you are considering taking Forteo.

• By my calculations, since its development, studies on this drug have included only 1943 patients. And according to the manufacturer, a study of one year is considered "long term," while the maximum length of any study was only two years. So, not only is Forteo relatively new, but it is also experimental and needs much more testing.
• Forteo is very expensive - the drug costs upwards of $600-700 per month!
• Forteo must be given as a daily self-administered injection, which may be a concern for some women.
• While there may be significant bone density gains while using Forteo, the research is clear that these gains are lost once the drug is stopped. In fact, to maintain bone density gains, antiresorptive drugs such as Fosamax must be used after stopping Forteo.

Can someone please explain to me how the FDA can approve something that was only tested for 2 years as "long term", and why would they approve something that caused cancer in rats?