Teriparatide

Teriparatide (Forteo) — Recombinant PTH 1-34

Evidence & Status

  • FDA Approved
  • Strong Human Evidence
  • Strong

At a Glance

An FDA-approved 34-amino-acid fragment of human parathyroid hormone used as an anabolic, bone-building therapy for osteoporosis in people at high fracture risk.

Plain English

Teriparatide helps researchers understand one of the most interesting features of parathyroid hormone biology: continuous exposure to high PTH can promote bone loss, while brief intermittent exposure can stimulate new bone formation. That discovery helped establish teriparatide as one of the major bone-building therapies for people with severe osteoporosis or high fracture risk.

Overview

Teriparatide is the recombinant 34-amino-acid N-terminal fragment of human parathyroid hormone (PTH 1-34). It is an anabolic osteoporosis therapy that stimulates new bone formation when administered intermittently. FDA-approved uses include treatment of postmenopausal women at high fracture risk, increasing bone mass in men with primary or hypogonadal osteoporosis at high fracture risk, and treatment of glucocorticoid-induced osteoporosis in men and women at high fracture risk. Intermittent PTH exposure produces a different skeletal effect from chronically elevated endogenous PTH, favoring bone formation.

Research Summary

Teriparatide has strong human evidence from randomized trials and long clinical experience. In the pivotal study of 1,637 postmenopausal women with prior vertebral fractures, daily PTH(1-34) reduced the relative risk of new vertebral fractures by about 65% with the 20 mcg dose and reduced nonvertebral fragility fractures by about 53% compared with placebo. Teriparatide also increased bone mineral density at the lumbar spine, femoral neck, and other skeletal sites. Later studies expanded its use to men with osteoporosis and to glucocorticoid-induced osteoporosis. Osteosarcoma occurred in rat studies, but human observational studies have not shown an increased risk. Current FDA labeling allows consideration of treatment beyond 2 years when a patient remains or returns to high fracture risk.

Research Areas

  • Osteoporosis
  • Bone mineral density
  • Fracture prevention
  • Anabolic bone therapy
  • PTH receptor pharmacology
  • Glucocorticoid-induced osteoporosis

Safety & Risks

Serious Risks

  • Osteosarcoma occurred in rat studies; human observational studies have not shown an increased risk, but data beyond 2 years of use are limited
  • Avoid use in patients with increased baseline risk of osteosarcoma, including Paget’s disease or other metabolic bone diseases, bone metastases or skeletal malignancy, prior skeletal radiation, open epiphyses, or hereditary disorders predisposing to osteosarcoma
  • Teriparatide can cause hypercalcemia and should be avoided in patients with underlying hypercalcemic disorders
  • Orthostatic hypotension can occur, particularly with early doses
  • Use caution in patients with active or recent urolithiasis or hypercalciuria

Reported Side Effects

  • Nausea
  • Leg cramps
  • Dizziness
  • Arthralgia
  • Transient increases in serum calcium
  • Injection site reactions
United States
FORTEO labeling supports treatment of specified patients at high fracture risk with postmenopausal, male primary/hypogonadal, or sustained-systemic-glucocorticoid-associated osteoporosis. Use beyond 2 years may be considered only when a patient remains or returns to high fracture risk.
United Kingdom
Product- and jurisdiction-specific.
Australia
Product- and jurisdiction-specific.
Canada
Product- and jurisdiction-specific.

Citations & Sources