Teriparatide
Encyclopedia
Teriparatide is a recombinant
form of parathyroid hormone
, used in the treatment of some forms of osteoporosis
. It is manufactured and marketed by Eli Lilly and Company
.
Coming in the form of a penfill designed for self injection like this of insulin,2 units or 20ug is given daily, subcutaneous.
.
Teriparatide should not be prescribed for patients who are at increased risks for osteosarcoma. This includes those with Paget's Disease
of bone or unexplained elevations of serum alkaline phosphate, open epiphysis
, or prior radiation therapy involving the skeleton.
, at least as seen in rat studies. Cases of bone tumor and osteosarcoma have been reported rarely in the postmarketing period.
(PTH), amino acid sequence 1 through 34, of the complete molecule (containing 84 amino acids). Endogenous PTH is the primary regulator of calcium and phosphate metabolism in bone and kidney. PTH increases serum calcium, partially accomplishing this by increasing bone resorption. Thus, chronically elevated PTH will deplete bone stores. However, intermittent exposure to PTH will activate osteoblasts more than osteoclasts. Thus, once-daily injections of teriparatide have a net effect of stimulating new bone formation leading to increased bone mineral density.
Teriparatide is the first, and to date only, FDA approved agent for the treatment of osteoporosis that stimulates new bone formation.
(FDA) on 26 November 2002, for the treatment of osteoporosis
in men and postmenopausal women who are at high risk for having a fracture. The drug is also approved to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.
Recombinant DNA
Recombinant DNA molecules are DNA sequences that result from the use of laboratory methods to bring together genetic material from multiple sources, creating sequences that would not otherwise be found in biological organisms...
form of parathyroid hormone
Parathyroid hormone
Parathyroid hormone , parathormone or parathyrin, is secreted by the chief cells of the parathyroid glands as a polypeptide containing 84 amino acids...
, used in the treatment of some forms of osteoporosis
Osteoporosis
Osteoporosis is a disease of bones that leads to an increased risk of fracture. In osteoporosis the bone mineral density is reduced, bone microarchitecture is deteriorating, and the amount and variety of proteins in bone is altered...
. It is manufactured and marketed by Eli Lilly and Company
Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States...
.
Administration
Teriparatide is administered by injection once a day in the thigh or abdomen. The recommended dose is 20 μg per day.Coming in the form of a penfill designed for self injection like this of insulin,2 units or 20ug is given daily, subcutaneous.
Uses
Teriparatide is indicated for use in patients with severe osteoporosis. The drug also has an ongoing clinical trial to evaluate its effectiveness in treating the symptoms of osteogenesis imperfectaOsteogenesis imperfecta
Osteogenesis imperfecta is a genetic bone disorder. People with OI are born with defective connective tissue, or without the ability to make it, usually because of a deficiency of Type-I collagen...
.
Teriparatide should not be prescribed for patients who are at increased risks for osteosarcoma. This includes those with Paget's Disease
Paget's disease
Sir James Paget, a surgeon and pathologist, described several diseases, including:* Paget's disease of bone * Paget's disease of the breast* Paget-Schroetter disease* Extramammary Paget's disease...
of bone or unexplained elevations of serum alkaline phosphate, open epiphysis
Epiphysis
The epiphysis is the rounded end of a long bone, at its joint with adjacent bone. Between the epiphysis and diaphysis lies the metaphysis, including the epiphyseal plate...
, or prior radiation therapy involving the skeleton.
Side effects
The most commonly reported side effects are nausea, leg cramps and dizziness. The main risk of teriparatide is an increased risk of osteosarcomaOsteosarcoma
Osteosarcoma is an aggressive cancerous neoplasm arising from primitive transformed cells of mesenchymal origin that exhibit osteoblastic differentiation and produce malignant osteoid...
, at least as seen in rat studies. Cases of bone tumor and osteosarcoma have been reported rarely in the postmarketing period.
Mechanism of action
Teriparatide is the portion of human parathyroid hormoneParathyroid hormone
Parathyroid hormone , parathormone or parathyrin, is secreted by the chief cells of the parathyroid glands as a polypeptide containing 84 amino acids...
(PTH), amino acid sequence 1 through 34, of the complete molecule (containing 84 amino acids). Endogenous PTH is the primary regulator of calcium and phosphate metabolism in bone and kidney. PTH increases serum calcium, partially accomplishing this by increasing bone resorption. Thus, chronically elevated PTH will deplete bone stores. However, intermittent exposure to PTH will activate osteoblasts more than osteoclasts. Thus, once-daily injections of teriparatide have a net effect of stimulating new bone formation leading to increased bone mineral density.
Teriparatide is the first, and to date only, FDA approved agent for the treatment of osteoporosis that stimulates new bone formation.
FDA approval
Teriparatide was approved by the Food and Drug AdministrationFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) on 26 November 2002, for the treatment of osteoporosis
Osteoporosis
Osteoporosis is a disease of bones that leads to an increased risk of fracture. In osteoporosis the bone mineral density is reduced, bone microarchitecture is deteriorating, and the amount and variety of proteins in bone is altered...
in men and postmenopausal women who are at high risk for having a fracture. The drug is also approved to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.