forteo

Teriparatide has been effective in treating people diagnosed with medication-related osteonecrosis of the jaw (MRONJ). However, its efficacy is not well established to be accepted as a standard of care. The objective of this paper was to investigate the efficacy of recombinant human parathyroid hormone for the treatment of MRONJ. We report three cases of MRONJ patients with osteoporosis as the primary disease who were treated with a teriparatide agent along with other adjunctive measures. Each patient was administered a teriparatide injection subcutaneously for 16 weeks, 36 weeks, or 60 weeks...

Stress fractures are a common injury that present in athletes because of the high intensity and repetitive nature of many sports. These injuries require a high index of suspicion in the treating clinician to allow for timely management. Though most low-risk fractures heal well with conservative management, high-risk stress fractures as well as any fracture in the elite athlete may warrant surgical intervention as well as an augmented treatment and rehabilitation regimen.

The phase 3 trials of the bone anabolic drug teriparatide were prematurely terminated because of a preclinical finding of osteosarcoma in rats treated with high doses of teriparatide for near lifetime. Even so, results from these and subsequent clinical trials showed efficacy and tolerability. Based on the phase 3 results and additional preclinical investigations, Forteo (teriparatide) was approved for use in the United States with an indication for the treatment of osteoporosis in patients at high risk for fracture, a boxed warning regarding potential risk of osteosarcoma, a 2-year lifetime limitation of use, other risk mitigations, and a requirement to assess for risk of osteosarcoma in humans treated with teriparatide...

Understanding, predicting, and minimizing the immunogenicity of peptide-based therapeutics are of paramount importance for ensuring the safety and efficacy of these products. The so-called anti-drug antibodies (ADA) may have various clinical consequences, including but not limited to the alteration in the product's distribution, biological activity, and clearance profiles. The immunogenicity of biotherapeutics can be influenced by immunostimulation triggered by the presence of innate immune response modulating impurities (IIRMIs) inadvertently introduced during the manufacturing process...

The Forteo Patient Registry estimated the incidence of osteosarcoma in US patients treated with teriparatide and enrolled in the study between 2009 and 2019. No incident cases of osteosarcoma were identified among patients registered, and the crude incidence rate was 0 (95% confidence interval [CI], 0-10.2) cases per million person-years. PURPOSE: The prospective, voluntary Forteo Patient Registry was established to estimate the incidence of osteosarcoma in patients who have received treatment with teriparatide (Forteo)...

CASE: A 78-year-old woman who underwent reverse total shoulder arthroplasty (RTSA) for proximal humerus fracture developed a Type-3 acromial stress fracture, resulting in increased pain and decreased function 9 months post-op. She was managed nonoperatively with adjunctive teriparatide (FORTEO), and after a 4-month course, she had regained excellent motion and achieved union. CONCLUSION: Teriparatide is a viable adjunct in treating patients nonoperatively with acromial stress fractures after RTSA...

Osteoporosis is a common and debilitating condition characterized by diminished bone mass and architecture leading to bone fragility. Antiresorptive medicines like bisphosphonates (and less commonly denosumab) are the typical first-line agents for the medical treatment of osteoporosis. However, newer anabolic agents have been shown to improve bone mass and architecture, as well as reduce fracture risk, to a greater degree than traditional antiresorptive therapies. Teriparatide (human recombinant parathyroid hormone (PTH) 1-34, Forteo, Ely Lilly, Indianapolis, IN), which was the first in class to be approved in the United States, is the most widely used anabolic osteoporosis medicine and has shown significant benefit over traditional antiresorptive therapies...

BACKGROUND CONTEXT: Despite the increasing national incidence, osteoporosis and its associated comanagement, often remain an overlooked issue in the orthopedic world. Screening and associated management of osteoporosis is often only considered by providers when patients present with multiple fragility fractures. Current evidence with regard to the trends in screening and medical comanagement/antiosteoporotic therapy of osteoporotic vertebral compression fractures (VCFs) remains limited...

Background: Due to high cost and burden of osteoporosis, it is reasonable to focus on the reduction of fractures as the main goal of treatment. We compared the efficacy and safety of a new biosimilar recombinant human parathyroid hormone (CinnoPar®, CinnaGen, Iran) to the reference product (Forteo®, Eli Lilly, USA) in a randomized double-blind clinical trial (RCT). Methods: Overall, 104 osteoporotic postmenopausal women aged 45-75 yr were randomized to receive 20 μg daily subcutaneous injections of either Forteo® or CinnoPar® for 6-months from 2011-2012...

UNLABELLED: The Forteo Patient Registry (FPR) aims to estimate the incidence of osteosarcoma in US patients treated with teriparatide. Enrollment began in 2009 and will continue through 2019, with linkage planned through 2024. To date, no incident cases of osteosarcoma have been identified among patients registered in the FPR. INTRODUCTION: The Forteo Patient Registry (FPR) was established in 2009 to estimate the incidence of osteosarcoma in US patients treated with teriparatide...

We present the case of a patient who presented with worsening chest pain and tachycardia. We were able to monitor her remotely through her pacemaker. She had been started on the injectable medication teriparatide (Forteo) and since then she had an increase in her symptoms. She was found to have intermittent atrial tachycardia with 1:1 conduction and occasional atrioventricular block transiently, coinciding with her injection of teriparatide. This specific-associated arrhythmia has yet to be described.

Approximately 10 million men and women in the U.S. have osteoporosis,1 a metabolic bone disease characterized by low bone density and deterioration of bone architecture that increase the risk of fractures.2 Osteoporosis-related fractures can increase pain, disability, nursing home placement, total health care costs, and mortality.3 The diagnosis of osteoporosis is primarily determined by measuring bone mineral density (BMD) using noninvasive dual-energy x-ray absorptiometry. Osteoporosis medications include bisphosphonates, receptor activator of nuclear factor kappa-B ligand inhibitors, estrogen agonists/antagonists, parathyroid hormone analogues, and calcitonin...

Teriparatide (TPTD) (recombinant DNA origin human parathormone [1-34]) is approved for the treatment of glucocorticoid-induced osteoporosis (GIO). There are reports of factors that affect the response to TPTD in GIO treatment. This work describes the case of a 71-yr-old woman diagnosed with lupus nephropathy treated with 40 mg/d of meprednisone, and who suffered multiple vertebral fractures. Despite treatment with a single 5 mg dose of zoledronic acid, the patient continued to have vertebral fractures. Treatment with 20 µg/d of subcutaneous TPTD (PTH1-34, Forteo; Eli Lilly Co...

Bisphosphonates (BPs) are the most widely used drugs to treat osteoporosis. However, recent reports associated to long-term BPs use with atypical low-impact fractures and prodromal pain. It is estimated that 26% of the cases of atypical fractures associated with the long-term use of BPs show delayed healing or nonunion. Teriparatide [PTH1-34] (TPTD) is an anabolic drug shown to be effective in stimulating bone formation. The aim was to describe the course of a right diaphyseal femoral fracture sustained by a patient on long-term BPs treatment...

UNLABELLED: There is a strong impetus to prevent and treat osteoporosis to prevent fractures. $990 million dollars was spent on anti-osteoporosis drugs in 2013. As we shift our focus on primary prevention of fractures, providers are encouraged to find the most cost-effective anti-osteoporosis therapy for patients. PURPOSE: Osteoporosis is a major global problem with osteoporotic fractures posing a potentially avoidable burden on healthcare resources. We studied the utilization and cost of anti-osteoporotic therapy using the 2013 Medicare Part D data...

Although most fractures heal, critical defects in bone fail due to aberrant differentiation of mesenchymal stem cells towards fibrosis rather than osteogenesis. While conventional bioengineering solutions to this problem have focused on enhancing angiogenesis, which is required for bone formation, recent studies have shown that fibrotic non-unions are associated with arteriogenesis in the center of the defect and accumulation of mast cells around large blood vessels. Recently, recombinant parathyroid hormone (rPTH; teriparatide; Forteo) therapy have shown to have anti-fibrotic effects on non-unions and critical bone defects due to inhibition of arteriogenesis and mast cell numbers within the healing bone...

OBJECTIVE: To compare the pharmacokinetics, relative bioavailability (RB), immunogenicity, and safety after a single dose of test or reference formulation of teriparatide in healthy human volunteers in order to demonstrate whether both products are similar. RESEARCH DESIGN AND METHODS: We compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers...

BACKGROUND: There is a medical need for therapies that improve hip fracture healing. Teriparatide (Forteo(®)/ Forsteo(®), recombinant human parathyroid hormone) is a bone anabolic drug that is approved for treatment of osteoporosis and glucocorticoid-induced osteoporosis in men and postmenopausal women at high fracture risk. Preclinical and preliminary clinical data also suggest that teriparatide may enhance bone healing. QUESTIONS/PURPOSES: We wished to test the hypotheses that treatment with teriparatide versus placebo would improve femoral neck fracture healing after internal fixation as measured by (1) frequency of revision surgery, (2) radiographic fracture healing, and (3) other outcomes including pain control, gait speed, and safety...

BACKGROUND AND PURPOSE: There is solid evidence from animal experiments that parathyroid hormone (PTH) improves fracture healing. So far, only 3 papers on PTH and fracture repair in humans have been published. They suggest that PTH may enhance fracture healing, but the results do not appear to justify specific clinical recommendations. This study was carried out to determine whether teriparatide enhances fracture healing of proximal humerus fractures. PATIENTS AND METHODS: 40 post-menopausal women with a proximal humerus fracture were randomized to either daily injections with 20 µg teriparatide (PTH 1-34 (Forteo)) for 4 weeks or control treatment...

BACKGROUND: The bioanalysis of Teriparatide (PTH 1-34) is extremely challenging due to the low plasma concentrations present at a therapeutic level. An LC-MS/MS-based method was developed that detected PTH 1-34 at 15 pg/ml in porcine plasma, and was validated using the bioanalytical method validation guidelines. RESULTS: The analytical methodology demonstrated good linearity over a range of 15-1000 pg/ml, and demonstrated good precision and accuracy. The validated method was used to support a trial comparing a solid state dose to a solution-based injection (Forteo™)...