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™ [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.
Media Articles Related to Forteo (Teriparatide)
Study: Include men in osteoporosis screening guidelines
Source: Bones / Orthopedics News From Medical News Today [2015.05.21]
Osteoporosis affects more men than prostate cancerMost people associate osteoporosis with women.
Osteoporosis screening is too common for low-risk women and too uncommon for higher-risk women
Source: Bones / Orthopedics News From Medical News Today [2015.05.20]
Many of those who should get it, don't. And many of those who shouldn't, do.. That's the story of a common screening test for osteoporosis, according to new research from UC Davis Health System.
Men far less likely to prevent, screen for osteoporosis
Source: Bones / Orthopedics News From Medical News Today [2015.05.15]
Up to 2 million American men suffer from osteoporosis and another 8 to 13 million have low bone density, with worse health outcomes than womenWhile the consequences of osteoporosis are worse in...
Men Should Be Screened for Osteoporosis, Too
Source: MedicineNet Mens Health Specialty [2015.05.15]
Title: Men Should Be Screened for Osteoporosis, Too
Category: Health News
Created: 5/15/2015 12:00:00 AM
Last Editorial Review: 5/15/2015 12:00:00 AM
Weight-Loss Surgery and Women's Osteoporosis Risk
Source: MedicineNet Obesity (Weight Loss) Specialty [2015.05.13]
Title: Weight-Loss Surgery and Women's Osteoporosis Risk
Category: Health News
Created: 5/13/2015 12:00:00 AM
Last Editorial Review: 5/13/2015 12:00:00 AM
Published Studies Related to Forteo (Teriparatide)
[Efficacy of teriparatide in treatment of glucocorticoid-induced osteoporosis]. [Article in Japanese] 
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...
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.
Reports of Suspected Forteo (Teriparatide) Side Effects
Pain in Extremity (643),
Back Pain (580),
Asthenia (572), more >>
Page last updated: 2015-05-21