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.
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FORTEO reduces the risk of vertebral fractures in postmenopausal women with osteoporosis.
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FORTEO reduces the risk of nonvertebral fractures in postmenopausal women with osteoporosis.
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FORTEO increases vertebral and femoral neck BMD in postmenopausal women with osteoporosis and in men with primary or hypogonadal osteoporosis.
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The effects of FORTEO on fracture risk have not been studied in men.
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NEWS HIGHLIGHTSMedia Articles Related to Forteo (Teriparatide)
Forteo Approved for Drug-Related Osteoporosis
Source: MedicineNet Bone Cancer Specialty [2009.07.27]
Title: Forteo Approved for Drug-Related Osteoporosis
Category: Health News
Created: 7/25/2009 7:00:00 AM
Last Editorial Review: 7/27/2009
Hormone Effective for Steroid-Induced Osteoporosis (CME/CE)
Source: MedPage Today Endocrinology [2009.10.29]
The synthetic parathyroid hormone teriparatide (Forteo) is an effective treatment for glucocorticoid-induced osteoporosis, a form of bone loss seen in patients treated with steroids, according to a study funded by the manufacturer.
Teriparatide Outperforms Alendronate In Treating Steroid-Induced Osteoporosis
Source: Arthritis / Rheumatology News From Medical News Today [2009.10.30]
A recent study determined glucocorticoid-induced osteoporosis (OP) is now treatable with Teriparatide, a synthetic form of the human parathyroid hormone. Researchers found patients with glucocorticoid-induced OP who were treated with teriparatide for 36 months had a greater increase in bone mineral density (BMD) and fewer new vertebral fractures than those treated with alendronate.
Better Drug Emerges for Steroid-Induced Bone Loss (HealthDay)
Source: Y! Health Bones, Joints & Muscles News [2009.10.29]
HealthDay - THURSDAY, Oct. 29 (HealthDay News) -- The drug teriparatide is
better at increasing bone density and reducing vertebral fractures in
patients with glucocorticoid-induced osteoporosis than the drug
alendronate, a new study finds.
Mutation In A MiroRNA: New Cause Of Osteoporosis
Source: Biology / Biochemistry News From Medical News Today [2009.11.17]
Many biological processes are controlled by small molecules known as microRNAs, which work by suppressing the expression of specific sets of genes. Xiang-Hang Luo and colleagues, at Second Xiangya Hospital of Central South University, People's Republic of China, have now identified a previously unknown microRNA (miR-2861) as crucial to bone maintenance in mice and humans.
Published Studies Related to Forteo (Teriparatide)
Effects of teriparatide retreatment in osteoporotic men and women. [2009.07]
CONTEXT: The stimulatory effect of teriparatide on bone mineral density (BMD) and bone turnover is initially exuberant, but then diminishes. OBJECTIVE: Our objective was to determine whether retreating with teriparatide after a drug-free period can restore the initial exuberant response to teriparatide... CONCLUSION: The response to teriparatide is attenuated when readministered after a 12-month hiatus.
Teriparatide and raloxifene reduce the risk of new adjacent vertebral fractures in postmenopausal women with osteoporosis. Results from two randomized controlled trials. [2009.06]
BACKGROUND: Vertebral fractures increase the risk of new vertebral fractures; however, we are not aware of any study addressing the risk of new vertebral fractures adjacent to existing vertebral fractures. Therefore, we sought to determine the influence of the number and severity of prevalent (preexisting) vertebral fractures on the risk of new adjacent vertebral fractures and to determine whether teriparatide (rhPTH [recombinant human parathyroid hormone] [1-34]) or raloxifene treatment reduces the incidence of adjacent vertebral fractures in postmenopausal women with osteoporosis... CONCLUSIONS: In untreated postmenopausal women with osteoporosis, nearly half of the incident vertebral fractures occur adjacent to an existing vertebral fracture. Both teriparatide and raloxifene can significantly reduce the occurrence of new adjacent and nonadjacent vertebral fractures.
Retreatment with teriparatide one year after the first teriparatide course in patients on continued long-term alendronate. [2009.06]
Patients treated with teriparatide after prior and ongoing alendronate therapy experience spine BMD increases; however, some continue to be at high risk for fracture, based on persistently low BMD and/or fracture history. The objective of this study was to determine whether a second discrete retreatment course with teriparatide could produce similar biochemical and BMD changes as seen during the first teriparatide course...
Vertebral fracture risk is reduced in women who lose femoral neck BMD with teriparatide treatment. [2009.06]
Response to osteoporosis therapy is often assessed by serial BMD testing. Patients who lose BMD without secondary causes of bone loss may be considered to be "nonresponders" to treatment... In conclusion, loss of FN BMD at 12 mo in postmenopausal women with osteoporosis treated with TPTD is nevertheless consistent with a good treatment response in terms of VF risk reduction.
Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment. [2009.04]
CONCLUSIONS: As assessed by QM plus SQ, teriparatide reduced the incidence of vertebral fractures.
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 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.
Teriparatide Use in Hip Replaced Subjects [Completed]
A pilot study on the use of Teriparatide in severe osteoporotic women with hip fracture and
submitted to hip replacement
The primary objective of this study is to obtain preliminary data, in a pilot group of
postmenopausal women with established osteoporosis and a recent hip fracture, who underwent
hip replacement 3-6 months before screening phase, about the effect of teriparatide on:
- bone turnover markers: CTx, PINP and BSAP when given at the dose of 20 mcg/day by
subcutaneous route for 18 months.
The secondary objectives of the study are as follows:
- Effects of teriparatide on lumbar spine and non-prosthetic femur bone density, as
assessed by BMD measurement with dual energy x-ray absorptiometry (DXA)
- Effects of teriparatide on quality of life and back pain during treatment.
Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis [Completed]
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