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Young People Get Osteoporosis Too 

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DISCLAIMER:

Please be advised that the inclusion of any medication on this site is not indicative of an endorsement.  I do not have any affiliation with the pharmaceutical corporations that manufacture prescription osteoporosis medications.  I am not a doctor, therefore I am not medically qualified to counsel or advise osteoporosis patients about which medication is best suited for their individual case.

• actonel • aredia • boniva • didronel • evista • Forteo • fosamax • miacalcin • zometa • vivelle • reclast •

FORTEO Customer CARE hotline toll free at 1-866-4FORTEO (1-866-436-7836)

Forteo is a natural bone-building hormone which appears to be the most effective treatment to date for osteoporosis, the brittle bone disease that afflicts millions of older Americans. The drug is based on the parathyroid hormone, which is ordinarily secreted by tiny glands in the neck. When given to volunteers with osteoporosis, it doubles their normal rate of bone formation. FORTEO is the first in a new class of drugs called bone formation agents that work primarily to stimulate new bone by increasing the number and action of bone-forming cells called osteoblasts.  Picture a road crew fixing potholes, and you have a good idea of how Forteo works to repair damage to bone.  Put another way, the damage in the bone is like potholes in a road.  Forteo works like a street paver by filling in the holes and adding a new surface over the entire area.

Forteo is only FDA approved to be prescribed for the treatment of osteoporosis in postmenopausal women who are at high risk for a fracture. It is also approved to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for a fracture. These include men (or women) with a history of osteoporosis-related fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy.  FORTEO should be prescribed only to patients for whom the potential benefits are considered to outweigh the potential risk.
 

Clinical Results:

The FDA's approval of Forteo was based on 24 clinical trials enrolling more than 2,800 postmenopausal women and men with osteoporosis. Phase III clinical trial data showed that Forteo stimulated new bone formation, lowered the risk of vertebral (spinal) fractures and increased bone mineral density (BMD) compared with placebo in postmenopausal women with osteoporosis during an average of 19 months of treatment. The data also showed that Forteo reduced the relative risk of spinal fractures by 65 percent (9.3 % absolute risk reduction), compared with placebo, and lowered the relative risk of nonspinal fractures overall (sites such as the wrist, ribs, hip, ankle/foot, etc.) by 53% (2.9% absolute risk reduction), compared with placebo.

In addition, Forteo also significantly increased spine BMD in postmenopausal women with osteoporosis beginning at three months of treatment. The data showed that 96% of women had an increase from baseline, with 72 percent achieving at least a 5 percent increase in spine BMD and 44% gaining 10 percent or more compared with placebo.

 

Why is it only given for two years?
Forteo works quickly. Though you may see results in just a few months, clinical research has shown that Forteo provides continual improvement in bone strength over a treatment period of 18 to 24 months. However, Forteo has not been studied beyond 2 years and is therefore not recommended for use beyond that period of time

Dr. Felicia Cosman, associate professor of clinical medicine at Columbia University in New York City and medical director of the National Osteoporosis Foundation states that Forteo may be given either alone, or with another drug to prevent bone loss, for no more than two years, partly because there is no information about the long-term effects of Forteo use and because "you don't get as much of an increase in bone mass after one or two years," Cosman says. "You get the biggest bang for the buck in the first year."

How will I know Forteo is working?
The main way to show that Forteo is working is through a bone mineral density test that your doctor may give you. According to research studies, patients using Forteo had a large increase in density of the bones in their spines in just three months.

Though Forteo works quickly when taken as prescribed, you won't feel the changes taking place in your body.  Doctors may take samples of blood and/or urine during the course of treatment to monitor their patients' responses to FORTEO. Forteo may cause hypercalcemia (an above normal calcium level) so the lab work will let the doctor know if that occurs.

What is the most important information I should know about FORTEO?
As part of drug testing, teriparatide, the active ingredient in FORTEO, was given to rats for a significant part of their lifetime. In these studies, teriparatide caused some rats to develop osteosarcoma, a bone cancer. Osteosarcoma in humans is a serious but very rare cancer. Osteosarcoma occurs in about 4 out of every million older adults each year. It is not known if humans treated with FORTEO also have a higher chance of getting osteosarcoma. FORTEO is approved for use in both men and postmenopausal (after the “change of life”) women with osteoporosis who are at high risk for having broken bones (fractures) from osteoporosis. Before starting treatment, talk with your doctor about the possible benefits and risks of FORTEO so you can decide if it is right for you.

Possible interactions of Forteo:
Some medicines or medical conditions may interact with Forteo. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking digoxin. Inform your doctor of any other medical conditions including kidney stones, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have high amounts of calcium in your blood (hypercalcemia), bone cancer or other bone disorders.
 

Why does Forteo have to be injected?
Forteo does not come in a pill because it is a small protein known as a "peptide."  Your digestive system would destroy it before it could reach your bloodstream, and it would never have a chance to do its job.  Injecting Forteo is the only way to get it into your bloodstream.  Scientists are working to get peptides like Forteo into a pill form, but that's probably a few years away.  Other osteoporosis drugs are not peptides and can be taken by pill

It's natural to be a little nervous about injecting Forteo. Two helpful things to remember are : 1) the needle is very small; and 2) the amount of the dose is so small. But most important is what Forteo can do to strengthen your bones--which may help make your anxiety a little easier to handle.
 

You should not take Forteo if you:

  1. have Paget’s disease of the bone
     
  2. have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget’s disease. If you are not sure, ask your doctor.
     
  3. are a child or growing adult
     
  4. have ever been diagnosed with bone cancer or other cancers that have spread (metastasized) to your bones
     
  5. have had radiation therapy involving your bones
     
  6. have certain bone diseases. If you have a bone disease, tell your doctor.
     
  7. have too much calcium in your blood (hypercalcemia)
     
  8. are pregnant or nursing
     
  9. have had an allergic reaction to FORTEO or one of its ingredients 
     
  10. have trouble injecting yourself and do not have someone who can help you
     

What special precautions should I follow?

Before taking teriparatide,

  • tell your doctor and pharmacist if you are allergic to teriparatide, mannitol, or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention either of the following: digoxin (Digitek, Lanoxin) and hydrochlorothiazide (HCTZ, Hydrodiuril, Microzide). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had any condition that causes you to have too much calcium in your blood, such as disease of the parathyroid gland; kidney or urinary tract stones; and liver, kidney, or heart disease.
  • you should know that teriparatide should only be used by women once they have passed menopause and, therefore, cannot become pregnant or breastfeed. Teriparatide should not be used during pregnancy or while breast-feeding.
  • you should know that teriparatide may cause fast heartbeat, dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking teriparatide. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. Be sure a chair is nearby when you inject teriparatide so you can sit down if you get dizzy.

What special dietary instructions should I follow?
It is important that you get enough calcium and vitamin D while you are taking teriparatide. Your doctor may prescribe supplements if your dietary intake is not enough. Talk to your doctor about doing weight-bearing exercise. Also talk to your doctor about avoiding cigarette smoking and avoiding drinking large amounts of alcohol.

What should I do if I forget a dose?
Take the missed dose as soon as you remember it that day. However, if the day has already passed, skip the missed dose and continue your regular dosing schedule. Never inject more than one dose per day.

What side effects can this medication cause?
Teriparatide may cause side effects. Tell your doctor if any of these symptoms or those listed in the SPECIAL PRECAUTIONS section are severe or do not go away:

  • pain
  • headache
  • weakness
  • diarrhea
  • heartburn or sour stomach
  • leg cramps
  • dizziness
  • depression

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them call your doctor immediately:

  • chest pain
  • fainting
  • difficulty breathing
  • fever, sore throat, chills, and other signs of infection
  • upset stomach
  • vomiting
  • constipation
  • lack of energy
  • muscle weakness

Teriparatide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

FORTEO should not be used to prevent osteoporosis or to treat patients who are not considered to be at high risk for fracture.
Tell your health care provider and pharmacist about all the medicines you are taking when you start taking FORTEO, and if you start taking a new medicine after you start FORTEO treatment. Tell them about all medicines you get with prescriptions and without prescriptions, as well as herbal or natural remedies. Your doctor and pharmacist need this information to help keep you from taking a combination of products that may harm you.

What was the deal with the rats who developed osteosarcoma during clinical trials?
 
One concern of researchers has been early experiments that showed the development of osteosarcoma (a rare bone cancer) in rats, but this is not believed to be relevant in humans. Doses three to sixty times those given to humans were given to the rats over the course of their lifetime. Further, rat bones grow in length through their entire lifetime; however, in humans, our bone ends close relatively early in life. The rat cancers developed at the ends of their bones, precisely where bone stops growing in late adolescence in humans. That's why the researchers do not believe that a two-year period of PTH treatment in older adults is likely to cause bone cancer

How should I take Forteo?

  1. Take FORTEO once a day for as long as your doctor prescribes it for you. Use of FORTEO for more than 2 years is not recommended. Your health care professional (doctor, nurse, or pharmacist) should teach you how to use the FORTEO pen 
     
  2.  Some patients get dizzy or get a fast heartbeat after the first few doses. For the first few doses, inject FORTEO where you can sit or lie down right away if you get dizzy.
     
  3. Inject FORTEO once each day in your thigh or abdomen (lower stomach area).
     
  4. You can take FORTEO with or without food or drink.
     
  5. You can take FORTEO at any time of the day. To help you remember to take FORTEO, take it at about the same time each day.
     
  6. Do not use FORTEO if it has solid particles in it, or if it is cloudy or colored. It should be clear and colorless.
     
  7. Do not use FORTEO after the expiration date printed on the pen and pen packaging.
     
  8. Throw away any FORTEO pen that you started using more than 28 days earlier, even if it still has medicine in it 
     
  9. Inject FORTEO shortly after you take the pen out of the refrigerator. Recap the pen and put it back into the refrigerator right after use 
     
  10. If you forget or are unable to take FORTEO at your usual time, take it as soon as possible on that day. Do not take more than one injection in the same day.
     
  11. Talk with your health care provider about other ways you can help your osteoporosis, such as exercise, diet, supplements, and reducing or stopping your use of tobacco and alcohol. If your health care provider recommends calcium and vitamin D supplements, you can take them at the same time as FORTEO.

What is the average price of a one month supply of Forteo?
it runs approximately $500.00 to $600.00 per month

What can I do if my doctor wants me on Forteo and I don't have medical insurance coverage?
If you do not have insurance coverage or have been denied coverage, you may call FORTEO Customer CARE for assistance. A reimbursement specialist will work with you to see if you qualify for the FORTEO Patient Assistance Program.  You may speak with a reimbursement specialist by calling the FORTEO Customer CARE hotline toll free at 1-866-4FORTEO (1-866-436-7836), weekdays between 8 AM and 7 PM eastern time.
 

How should I store FORTEO?

  1. Keep your FORTEO pen in the refrigerator at 36 to 46F (2 to 8C).Do not freeze the pen. Do not use FORTEO if it has been frozen.
     
  2. You can use your FORTEO pen for up to 28 days after the first injection from the pen.
     
  3. Throw away the pen properly after 28 days of use, even if it is not completely empty.
     
  4. Recap the pen after each use to protect from physical damage.
     

How should I store Forteo while traveling?
While traveling you may transport your Forteo injection pen in a cooler or an insulated pouch such as those used by diabetic patients to carry insulin that requires refrigeration.  Here is a link to a case that will keep the Forteo Pen a 36 to 46 F (2 to 8 C.
http://www.medicool.com/diabetes/pa-bc.html 

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

  • upset stomach
  • vomiting
  • dizziness
  • headache
  • lightheadedness and fainting on standing
  • constipation
  • lack of energy
  • muscle weakness

Where is Forteo available by prescription?
It is available in the United States of America.  It was just announced in 6/03 that Forteo was Approved by the European Commission for the Treatment of Established Osteoporosis in Women (read the press release below).  This announcement means that Forteo will become available in the following countries: 

Research Evidence of Forteo:
The key research on which the FDA approval of teriparatide was based was a double-blind, controlled trial of teriparatide involving 1,637 postmenopausal women with prior vertebral fractures - bone breaks in their backs.[2] The women were randomly assigned to receive 20 or 40 mcg. of PTH or placebo (a dummy injection), self-injected daily. They were monitored with vertebral X-rays and DEXA - the best way to monitor bone density. Side effects were minor - nausea (9%), headache (8%), and leg cramps (3%).

The higher dose of teriparatide increased vertebral BMD by 14%, and the lower (now FDA-approved) dose yielded an average 10% increase in the lumbar spine BMD, as well as an increase in hip BMD of 2.8%

The risk of new vertebral fractures was reduced by 65% in the group that got the approved dose of 20 mcg. Such fractures occurred in 14% of the women on placebo group and in 5% and 4%, respectively, of those on 20 and 40 mcg of PTH.

There were only four hip fractures in placebo group vs. one in the approved dose group; so no definitive statement could be made with regard to hip fracture reduction. However, the impact of PTH on total non-vertebral fractures - including hip, wrist, rib, foot, ankle, arm, pelvis, etc. - yielded a statistically significant relative risk reduction of 53%.

The study concluded that "Treatment of postmenopausal osteoporosis with parathyroid hormone (1-34) decreases the risk of vertebral and nonvertebral fractures; increases vertebral, femoral, and total-body bone mineral density; and is well tolerated." [2]

One concern of researchers has been early experiments that showed the development of osteosarcoma (a rare bone cancer) in rats, but this is not believed to be relevant in humans. Doses three to sixty times those given to humans were given to the rats over the course of their lifetime. Further, rat bones grow in length through their entire lifetime; however, in humans, our bone ends close relatively early in life. The rat cancers developed at the ends of their bones, precisely where bone stops growing in late adolescence in humans. That's why the researchers do not believe that a two-year period of PTH treatment in older adults is likely to cause bone cancer.