Osteoporosis Disease Specific Site

Teriparatide

Teriparatide is a recombinant parathyroid hormone (PTH) that increases serum calcium and decreases serum phosphate by altering their metabolism in the bone and kidney. Teriparatide stimulates bone formation and resorption. Therefore, it can either increase or decrease bone mass, depending on the level of exposure. Continuous infusions result in greater bone resorption, whereas intermittend exposure results in decreased bone turnover, increased formation of new bone, and increased bone mass due to a net stimulation of osteoblast activity.

Indications and Dosage

Osteoporosis in postmenopausal women and in men with primary or hypogonadal osteoporosis

Dose: 20 mcg SC once daily for up to 2 years

Corticosteroid-induced osteoporosis

Dose: 20mcg or 25 mcg SC once daily for up to one year

Hypoparathyroidism (not FDA approved)

Dose: Initially 0.7mcg/kg/dose SC once or twice daily, and increased or decreased by 5-10% to maintain urine and calcium levels within normal values.

Administration and Storage

Subcutaneously in the thigh or abdominal wall; under circumstances where the patient can sit or lie down if symptoms of orthostatic hypotension occur.

Refrigerate at 2-8 C (36-46 F)

Each pen can be used for up to 28 days after the first injection.

Patient should visually inspect injection solution for particulate matter and discoloration prior to administration.

Adverse Reactions

Hypertension, syncope, angina, dizziness

Warning

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. Patients who are at increased baseline risk for osteosarcoma are: including those with Paget disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, or prior radiation therapy involving the skeleton).

Clinical Studies

Intermittent weekly administration of hPTH-34 (human parathyroid hormone) has increased lumbar bone mineral density, suggesting usefulness in the treatment of osteoporosis.⁵² Recently, it has been reported that in 1637 women with prevalent vertebral fractures, 21 months of therapy with PTH reduced vertebral fractures by 63% (95% CI, 45%-78%) and nonvertebral fractures by 54% (95%CI, 12%-75%).⁵³ The authors concluded that treatment of postmenopausal osteoporosis with parathyroid hormone (1-34) decreases the risk of vertebral and nonvertebral fractures; increases vertebral, femoral, and total-body bone mineral density; and is well tolerated. The 40-microgram dose increased bone mineral density more than the 20-microgram dose, but had similar effects on the risk of fracture and was more likely to have side effects (nausea and headache).

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