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Forteo (Teriparatide) - Summary

 
 



WARNING

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, teriparatide should be prescribed only to patients for whom the potential benefits are considered to outweigh the potential risk. Teriparatide 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, open epiphyses, or prior external beam or implant radiation therapy involving the skeleton) ( see WARNINGS and PRECAUTIONS, Carcinogenesis).

 

FORTEO SUMMARY

FORTEO™ [teriparatide (rDNA origin) injection] contains recombinant human parathyroid hormone (1-34), [rhPTH (1-34)], which has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone.

FORTEO is indicated for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture. These include women with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant of previous osteoporosis therapy, based upon physician assessment (see BLACK BOXED WARNING). In postmenopausal women with osteoporosis, FORTEO increases BMD and reduces the risk of vertebral and nonvertebral fractures.

FORTEO is indicated to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment (see BLACK BOXED WARNING). In men with primary or hypogonadal osteoporosis, FORTEO increases BMD. The effects of FORTEO on risk for fracture in men have not been studied.

  • FORTEO reduces the risk of vertebral fractures in postmenopausal women with osteoporosis.
  • FORTEO reduces the risk of nonvertebral fractures in postmenopausal women with osteoporosis.
  • FORTEO increases vertebral and femoral neck BMD in postmenopausal women with osteoporosis and in men with primary or hypogonadal osteoporosis.
  • The effects of FORTEO on fracture risk have not been studied in men.


See all Forteo indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Forteo (Teriparatide)

Breast, lung and colon cancers may be prevented by widely used osteoporosis drugs
Source: Bones / Orthopedics News From Medical News Today [2014.12.03]
The most commonly used medications for osteoporosis worldwide, bisphosphonates, may also prevent certain kinds of lung, breast and colon cancers, according to two studies led by researchers at the...

Thyroid Disease, Osteoporosis and Calcium
Source: MedicineNet Hyperthyroidism Specialty [2014.12.01]
Title: Thyroid Disease, Osteoporosis and Calcium
Category: Doctor's Views
Created: 10/2/2001 12:00:00 AM
Last Editorial Review: 12/1/2014 12:00:00 AM

A treatment for osteoporosis and bone cancer, employed for the first time in dental filling procedures
Source: Dentistry News From Medical News Today [2014.10.23]
Journal of Dental Research publishes a paper directed by Salvatore Sauro, Professor at University CEU Cardenal Herrera in Spain, in collaboration with international researchers from Finland...

Osteoporosis Pictures Slideshow: Are Your Bones at Risk?
Source: MedicineNet Lactose Intolerance Specialty [2014.09.09]
Title: Osteoporosis Pictures Slideshow: Are Your Bones at Risk?
Category: Slideshows
Created: 4/23/2009 12:00:00 AM
Last Editorial Review: 9/9/2014 12:00:00 AM

Osteoporosis Drugs Work, But Review Finds No Clear Winner
Source: MedicineNet risedronate Specialty [2014.09.09]
Title: Osteoporosis Drugs Work, But Review Finds No Clear Winner
Category: Health News
Created: 9/8/2014 5:36:00 PM
Last Editorial Review: 9/9/2014 12:00:00 AM

more news >>

Published Studies Related to Forteo (Teriparatide)

[Efficacy of teriparatide in treatment of glucocorticoid-induced osteoporosis]. [Article in Japanese] [2012]
The skeletal effects of glucocorticoids include both direct and indirect actions on bone that result early, transient in bone resorption accompanied by a decrease in bone formation, which is maintained for the duration of glucocorticoid therapy. Teriparatide exerts anabolic effects on bone, so it is understandable why teriparatide is thought to be a rational treatment option...

Consistency of fracture risk reduction in Japanese and Caucasian osteoporosis patients treated with teriparatide: a meta-analysis. [2011.09.21]
In the global Fracture Prevention Trial, teriparatide reduced the risk of vertebral and non-vertebral fractures and significantly increased BMD. Recently, a 12-month, phase 3, randomized, multicenter, double-blind, placebo-controlled trial with BMD as a primary endpoint was conducted to assess the effects of teriparatide in Japanese subjects at high risk of fracture...

Effects of teriparatide in Japanese and non-Japanese populations: bridging findings on pharmacokinetics and efficacy. [2011.09.21]
Teriparatide is an anabolic therapy for osteoporosis approved in the United States since 2002 and European Union since 2003; however, approval in Japan lagged significantly. This report describes analyses based on International Conference on Harmonisation (ICH) E-5 guidelines that support bridging between Japanese studies and the large Fracture Prevention Trial (FPT)...

Short-term teriparatide delivery and osseointegration: a clinical feasibility study. [2011.08]
Teriparatide is an anabolic osteoporosis therapeutic agent that can improve healing after fractures and periodontal surgeries.The results provide the first histological data on the osseointegration of titanium study implants in individuals treated with teriparatide.

Comparative effects of teriparatide and strontium ranelate in the periosteum of iliac crest biopsies in postmenopausal women with osteoporosis. [2011.05.01]
The periosteum contains osteogenic cells that regulate the outer shape of bone and contribute to determine its cortical thickness, size and position. We assessed the effects of subcutaneous injections of teriparatide (TPTD, 20mug/day) or oral strontium ranelate (SrR, 2g/day) in postmenopausal women with osteoporosis on new bone formation activity at the periosteal and endosteal bone surfaces using dynamic histomorphometric measurements...

more studies >>

Clinical Trials Related to Forteo (Teriparatide)

Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy [Active, not recruiting]
This study is being conducted to collect information from subjects with osteoporosis regarding their experience using the Forteo B Pen to self-administer teriparatide in the community setting. Information collected during this study will be used to assess the need for changes to the Forteo B-Pen User Manual and patient educational tools. Additionally, the information generated from patients during this trial will be reviewed to assess the acceptability of the Forteo B Pen for commercial launch.

Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis [Completed]
The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.

Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta [Recruiting]
The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI). There is no established medical therapy for adults with the disorder. Virtually all of the studies reviewing potential treatments for OI have evaluated the effects of medications only on children with OI. There is no data concerning the usefulness of parathyroid hormone therapy in OI. The working hypothesis is that adults affected with OI who are treated with FORTEO will experience increased spine and hip bone mineral density and an increase in bone width and thickness. Adult patients with OI will be enrolled in this study for 18 months. Half the patients will receive PTH (FORTEO) and the other half placebo (no active drug). Blood, urine, and bone density tests will be done during the study for safety monitoring.

There are three clinic sites for this study; Oregon Health & Science University (Portland, OR), Kennedy Krieger Institute (Johns Hopkins University, Baltimore, MD), and Baylor College of Medicine (Houston, TX).

Teriparatide for Postsurgical Hypoparathyroidism [Recruiting]
Will teriparatide ( Forteo) shorten the length of hospitalization post thyroidectomy in patients with symptomatic hypoparathyroidism

Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD [Withdrawn]
This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.

more trials >>

Reports of Suspected Forteo (Teriparatide) Side Effects

Fall (1443)Pain (810)Hospitalisation (766)Malaise (712)Pain in Extremity (643)Nausea (633)Arthralgia (625)Dizziness (612)Back Pain (580)Asthenia (572)more >>


Page last updated: 2014-12-03

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