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Osteoporosis – A possible treatment solution

Leroy Jemison, Jr.

September24, 2007

 

 

 

 

 

 

 

 

 

 

 

Background Information: In the United States, an estimated 10 million individuals have osteoporosis and almost 34 million more are estimated to have low bone mass, placing them at an increased risk for Osteoporosis, according to the National Osteoporosis Foundation. In addition one in two women and one in four men over age 50 will have an osteoporosis related fracture in his/her lifetime. (http://www.nastech.com/nastech/parathyroid)

 

What is the purpose of Forteo?

-         The purpose of Forteo (teriparatide) is to prevent and treat osteoporosis.

 

 

 

 

 

 

 

 

How is Forteo Supposed to achieve its purposes?

-         Forteo is supposed to achieve its purposes by increasing bone density and increasing bone strength to help prevent fractures. (http://www.drugs.com/forteo.html)

-         Forteo is the only treatment that actually prompts the body to make new bone. (http://www.usatoday.com/news/health/2001-05-09-osteoporosis-drug.htm)

-         Forteo contains the parathyroid hormone which increases the normal rate of bone formation.

 

What are the claims made about the effectiveness of Forteo?

-         Forteo is approved by the Federal Drug Administration (FDA) (http://www.healthcentral.com/osteoporosis)

-         Forteo causes certain side effects such as mild dizziness, leg cramps, joint pain, cough, sore throat, and runny nose. (http://www.drugs.com/forteo.html)

-         Forteo is not a safe treatment for osteoporosis. (http://www.webmd.com/osteoporosis/news/20030404/dont-use-forteo-consumer-group-urges)

-         Forteo is a safe treatment for osteoporosis if taken correctly. (http://www.aafp.org/afp/20040415/steps.html)

-         (http://www.lilly.com)

-         Forteo is the most effective treatment ever for osteoporosis.

-         Forteo is the only treatment that actually prompts the body to make new bone

(http://www.usatoday.com/news/health/2001-05-09-osteoporosis-drug.htm

-         Forteo increases bone density and increases bone strength

 

 

 

 

 

 

 

 

 

 

What evidence if any is offered in support of the above claims for Forteo?

-         “The National Osteoporosis Foundation conducted a study on 1,637 postmenopausal women who had suffered at least one fracture because of osteoporosis and after 18 months of treatment women taking the higher dose of the drug had 13% more bone in their spines then did those on placebo. Forteo reduced the occurrence of new vertebral fractures by 65% or 69%, depending on whether women got the high or low dose. Forteo reduced the risk of multiple spinal fractures by 77% and lowered the risk of fractures elsewhere in the body by just over half.” (http://www.usatoday.com/news/health/2001-05-09-osteoporosis-drug.htm).

 

 

 

 

 

 

 

 

 

-         The Public Citizen Health Research Group warned the FDA not to approve Forteo because it appeared to cause a kind of bone cancer in lab rats.

(http://www.webmd.com/osteoporosis/news/20030404/dont-use-forteo-consumer-group-urges)

 

-         “In a separate double-blind, placebo-controlled study of 437 men with idiopathic or hypogonadal osteoporosis, teriparatide, in combination with 1,000mg calcium and 400 IU vitamen D daily, significantly increased bone mass density over 10 months of treatment, compared with placebo. 94% had an increase in their spinal BMD; 53% of men taking teriparatide had an increase of spinal BMD greater than or equal to 5% at the close of the study, compared with 10% of men in the placebo group.” (http://www.medscape.com/viewarticle/460825)

 

 

 

 

 

 

 

What evidence from professional/scientific journals or primary research reports supports the above claims for Forteo?

-A study was performed by the Department of Medicine at the University of California at San Francisco to determine whether daily treatment of the parathyroid hormone for one year was associated with a change in vertebral cross-sectional area, or vertebral size in women with osteoporosis. 51 postmenopausal women treated chronically with both glucocotoids and hormone replacement therapy were randomized to either daily parathyroid hormone or to a control group treated only with HRT. The study concluded that parathyroid hormone does increase the verbal cross-sectional area and vertebral size.

http://www.ncbi.nlm.nih.gov/sites/entrez?termClinical=Parathyroid%20Hormone%20associated%20with%20an%20increase%20in%20vertebral%20cross%20sectional%20area&precision=specificity&strategy=therapy&filters=&orig_db=PubMed&db=PubMed&cmd=Search&term=%28Parathyroid%20Hormone%20associated%20with%20an%20increase%20in%20vertebral%20cross%20sectional%20area%29%20AND%20%28randomized%20controlled%20trial%5BPublication%20Type%5D%20OR%20%28randomized%5BTitle%2FAbstract%5D%20AND%20controlled%5BTitle%2FAbstract%5D%20AND%20trial%5BTitle%2FAbstract%5D%29%29

 

 

 

-A study was performed by the Department of Medicine at the University of Colorado Health and Sciences Center which determined the safety and efficacy of Forteo (teriparatide) in postmenopausal women with osteoporosis. In the study patients were randomized to receive daily injections of 20 to 40 mg/day of placebo or teriparatide. The study concluded that compared with placebo, teriparatide significantly increased lumber spine and femoral neck bone mass density in the patients.  (http://www.ncbi.nlm.nih.gov/sites/entrez?Db=PubMed&Cmd=ShowDetailView&TermToSearch=17013567&ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum)

 

-A study was performed by the Department of Endocrinology at Ghent University Hospital which determined what effects teriparatide had on vertebral fractures and bone mineral density in men with osteoporosis. The study was performed by giving 355 men daily self injections of either placebo or between 20 and 40 mg of teriparatide over a 42 month period. The study concluded that men who received teriparatide had a more decreased risk of moderate and severe vertebral fractures then men who received the placebo.

(http://www.ncbi.nlm.nih.gov/sites/entrez?Db=PubMed&Cmd=ShowDetailView&TermToSearch=15322742&ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum)

 

 

-A study was performed by the Osteoporosis and Arthritis Research Group, and the Department of Radiology at the University of California, San Francisco. They studied the ability of teriparatide injection to improve both cancellous and cortical bone in a subset of women enrolled in the Fracture Prevention Trial of postmenopausal women with osteoporosis after a mean treatment time of 19 months. The study concluded that teriparatide increased cancellous connectivity density and increased cortical thickness.

(http://www.ncbi.nlm.nih.gov/sites/entrez?termClinical=Recombinant%20human%20parathyroid%20hormone%20improves%20both%20cancellous%20bone%20structure&precision=specificity&strategy=therapy&filters=&orig_db=PubMed&db=PubMed&cmd=Search&term=%28Recombinant%20human%20parathyroid%20hormone%20improves%20both%20cancellous%20bone%20structure%29%20AND%20%28randomized%20controlled%20trial%5BPublication%20Type%5D%20OR%20%28randomized%5BTitle%2FAbstract%5D%20AND%20controlled%5BTitle%2FAbstract%5D%20AND%20trial%5BTitle%2FAbstract%5D%29%29

 

 

-A study was performed by the Creighton University Medical Center which determined what percentage of women attained a lumbar spine BMD response to teriparatide that equaled or exceeded the least significant change value of 3%. The study was performed with 3 different clinical trials. The first trial was a clinical prevention trial which was a double blinded, placebo controlled clinical trial examining the safety and efficacy of teriparatide. The other two trials were double blinded, head to head comparisons of alendronate 10mg per day and teriparatide 20 to 40 mg per day. The study concluded that in the teriparatide 20mg alendornate head to head trial, 94% of women receiving teriparatide had a lumbar spine BMD response that equaled or exceeded the 3% criterion at 18 months compared to 75% of those receiving alendronate. In the teriparatide 40mg per day group of the other head to head trial 92% of women achieved the 3% criterion for the lumbar spine at 12 months compared to 69% of those receiving alendronate 10mg per day.

(http://www.ncbi.nlm.nih.gov/sites/entrez?Db=PubMed&Cmd=ShowDetailView&TermToSearch=16884968&ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum)

 

 

 

 

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