WARNING: POTENTIAL RISK OF OSTEOSARCOMA
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, prescribe FORTEO® only for patients for whom the potential benefits are considered to outweigh the potential risk. FORTEO 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, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton) [see Warnings and Precautions Adverse Reactions (6.2), and Nonclinical Toxicology].
FORTEOâ¢ [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)
In search of a treatment for osteoporosis from the tequila agave
Source: Arthritis / Rheumatology News From Medical News Today [2016.04.12]
Substances from the plant that enhance absorption of calcium in the body have been identified.
Source: MedicineNet Osteoporosis Specialty [2016.04.07]
Category: Symptoms and Signs
Created: 4/7/2016 12:00:00 AM
Last Editorial Review: 4/7/2016 12:00:00 AM
For treating hyperparathyroidism - a leading cause of osteoporosis, surgery is better than widely used medications
Source: Bones / Orthopedics News From Medical News Today [2016.04.05]
UCLA study finds that using drugs to combat hyperparathyroidism is worse than doing nothing at allWhile most cases of osteoporosis are caused by normal aging, another leading cause of the bone-loss...
UCB and Amgen announce positive topline results from Phase 3 study evaluating romosozumab in men with osteoporosis
Source: Arthritis / Rheumatology News From Medical News Today [2016.03.21]
UCB and Amgen has announced positive top-line results for romosozumab from the pivotal Phase 3 placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with...
Population health: Statewide study finds decreasing rates of osteoporosis treatment
Source: Compliance News From Medical News Today [2015.09.15]
A statewide study has found that from 2005 to 2012, fewer than a quarter of men and women with documentation of osteoporosis or fragility fracture, conditions for which national guidelines would...
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 Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta [Completed]
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).
Study of FORTEO Use in Subjects in the Community Setting [Completed]
The purpose of this study is to evaluate the long-term effectiveness, safety, and
tolerability of FORTEO in a larger, more diverse "real world" population than studied in
Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy [Completed]
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.
Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia [Terminated]
- To identify the optimal dose of a seven-day course of twice-daily teriparatide as compared
to standard therapy for hypocalcemia in patients after total thyroidectomy and/or extensive
neck dissections (pharyngectomy, laryngectomy,unilateral, bilateral / central neck,
mediastinal lymph node neck dissections), with which serum calcium will be raised to
corrected serum calcium levels of 8-10. 5mg/dL and maintained within this range until the end
of the treatment course.
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.
Reports of Suspected Forteo (Teriparatide) Side Effects
Pain in Extremity (643),
Back Pain (580),
Asthenia (572), more >>
Page last updated: 2016-04-12