DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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)

Following a bone fracture, older men less likely to receive osteoporosis screening and treatment
Source: Bones / Orthopedics News From Medical News Today [2014.11.07]
Osteoporosis, a common condition causing progressive bone loss and increased fracture risk, is primarily thought of as a disease affecting older women.

Osteoporosis drug has potential to treat breast and other cancers
Source: Bones / Orthopedics News From Medical News Today [2014.11.07]
Australian researchers have shown why calcium-binding drugs commonly used to treat people with osteoporosis, or with late-stage cancers that have spread to bone, may also benefit patients with...

Osteoporosis Screening Guidelines May Miss Younger Women at Risk
Source: MedicineNet Menopause Specialty [2014.10.27]
Title: Osteoporosis Screening Guidelines May Miss Younger Women at Risk
Category: Health News
Created: 10/24/2014 12:00:00 AM
Last Editorial Review: 10/27/2014 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...

Health Tip: Know the Risk Factors for Osteoporosis
Source: MedicineNet Osteoporosis Specialty [2014.10.14]
Title: Health Tip: Know the Risk Factors for Osteoporosis
Category: Health News
Created: 10/14/2014 12:00:00 AM
Last Editorial Review: 10/14/2014 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.

Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action [Recruiting]
Previously the approach to treatment of osteoporosis has been to use medications which prevent excessive resorption of bone. More recently medications that build up new bone, i. e. anabolic treatments, have been, and are being, developed. The investigators would like to develop a strategy for evaluating the effectiveness of anabolic therapies by studying a currently available therapy (teriparatide). This strategy could then be used to assess new anabolic treatments as they are developed for use in humans.

The aims of this study are 1) to fully describe the changes in bone turnover in response to teriparatide by biochemical marker type and by time; 2) to fully describe the changes in bone mineral density (BMD) in response to teriparatide by site, bone compartment and time.

If this study is able to identify an early response to treatment, then this will help speed up drug development in this area, by allowing the identification of promising new anabolic drugs and enabling us to understand their mechanism of action. This will benefit the investigators patients as the investigators will have a better understanding of how these drugs work.

Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women [Recruiting]
Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise completely healthy individuals with no secondary cause of bone loss. In the course of our prior research with premenopausal women with IOP, the investigators have shown that women with IOP have low areal bone mineral density (aBMD) at the spine, hip and forearm compared to normal women. Additionally, using noninvasive high resolution imaging of the central and peripheral skeleton and detailed analyses of transiliac crest bone biopsies, the investigators identified several features of bone quality in premenopausal women with IOP.

There is currently no FDAapproved therapy for IOP in premenopausal women. However, teriparatide (Forteo) has been shown to improve bone mass and microarchitecture in postmenopausal women and is approved for men with primary or idiopathic osteoporosis, as well as men, premenopausal and postmenopausal women with glucocorticoid-induced osteoporosis. Because IOP in premenopausal women is an orphan disease, with an estimated prevalence of about 113,000 in the United States, pharmaceutical companies are unlikely to support development of therapies for this indication. Therefore the major objective of this protocol is to establish the safety and efficacy of teriparatide in premenopausal women with IOP in a phase 2 clinical trial. All subjects will receive teriparatide as part of the study, but a randomly selected group of patients (10) will receive one year of placebo injections first before starting their two years of treatment. The remainder of subjects (30) will receive active drug only for two years.

Effects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis [Recruiting]
Teriparatide (PTH) is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada. Osteoporosis is currently diagnosed using a bone mineral density (BMD) scan, which measures the amount of mineral (calcium etc) in bones (the higher the amount of mineral, the lower the fracture risk). Although BMD is linked to bone strength and is used to measure fracture risk, it does not give information on bone structure (called bone geometry) which can also tell us a great deal about fracture risks. Clinical trials have shown that teriparatide increases BMD at the lumbar spine and total hip, while BMD at the forearm may decrease after 20 months of therapy. However, bone biopsies of the pelvis done on people taking teriparatide show improvement of bone geometry (ie bone thickness and increased trabeculae (small interconnecting rods of bone), suggesting that a change in bone geometry at the wrist may be occurring as well. Currently, there is a new technology, high resolution pQCT (HR-pQCT) that can assess bone geometry without a biopsy. Since bone strength is affected both by BMD and bone structure (as well as other material properties), our group is interested in examining changes in bone geometry at the radius and tibia in men and women with osteoporosis who receives 24 months of teriparatide therapy.

The investigators believe that this new approach of measuring bone strength will help us better understand the mechanisms of therapeutic efficacy of teriparatide. In addition, measuring indices of bone strength such as the material composition (bone mineral content or BMD) and structural properties of bone (size and shape, and microarchitecture) may provide more data about the mechanisms of how teriparatide treatment can decrease fracture risk. In the end, this data will benefit and improve patient care by allowing us to show patients and their providers that whether BMD increases, decreases or stay the same, there are changes in their bone geometric structure with teriparatide therapy that increases bone strength.

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: 2014-11-07

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014