Teriparatide
Parathyroid hormone analogue (bone-building agent)
Status
Approved
Approved by FDA (Forteo, 2002) and the EU (Forsteo, 2003) for osteoporosis at high risk of fracture; the US label no longer carries a boxed osteosarcoma warning but still advises weighing use beyond 2 years.
Evidence
Strong
Large randomized trials, including the 1,637-woman Fracture Prevention Trial and the head-to-head VERO trial, show fewer vertebral fractures.
Teriparatide is the active first 34 amino acids of human parathyroid hormone, made by recombinant technology. Given as a daily injection, it stimulates new bone formation and is approved for osteoporosis in people at high risk of fracture.
Structure
34 residuesPoint at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.
Sequence as text
H-S-V-S-E-I-Q-L-M-H-N-L-G-K-H-L-N-S-M-E-R-V-E-W-L-R-K-K-L-Q-D-V-H-N-F-OH
What it is used for
- Postmenopausal osteoporosis at high risk of fracture (approved)
- Primary or hypogonadal osteoporosis in men at high risk of fracture (approved)
- Osteoporosis caused by long-term glucocorticoid treatment (approved)
How it works
Teriparatide binds the same receptors as natural parathyroid hormone, with the same affinity, on bone and kidney cells. Continuously high parathyroid hormone breaks bone down, but a brief once-daily peak stimulates bone-forming cells (osteoblasts) more than bone-resorbing cells, so bone mass and strength increase, especially in the spine. This makes it an anabolic, or bone-building, treatment, unlike bisphosphonates, which mainly slow bone loss.
How strong the evidence is
Strong
In the Fracture Prevention Trial, 1,637 postmenopausal women with prior vertebral fractures received placebo or teriparatide (median about 19 months): new vertebral fractures fell from 14% to 5% (relative risk 0.35) and non-vertebral fragility fractures from 6% to 3% (Neer 2001, NEJM). In VERO, 1,360 women with severe osteoporosis had fewer new vertebral fractures on teriparatide than on the bisphosphonate risedronate (5.4% versus 12.0%) (Kendler 2018, Lancet). A 15-year US surveillance study found osteosarcoma incidence among teriparatide users no different from background rates (Gilsenan 2021).
Risks and side effects
- Dizziness or light-headedness from a drop in blood pressure after early doses
- Joint pain, general pain and nausea
- Raised blood calcium, possible worsening of kidney stones and digoxin toxicity
- Osteosarcoma in rats; avoid in people at higher risk, such as those with Paget's disease, prior skeletal radiation or open growth plates
- Serious allergic reactions, including anaphylaxis
Label dosing
Label: 20 mcg injected under the skin of the thigh or abdomen once daily; use beyond 2 years in a lifetime only if fracture risk remains high.
Regulatory status
| Region | Year | Approved for |
|---|---|---|
| USFDA | 2002 | Osteoporosis at high risk for fracture in postmenopausal women and men, including glucocorticoid-induced osteoporosis |
| EUEMA | 2003 | Osteoporosis in postmenopausal women and in men at increased risk of fracture |
Status by country
| Jurisdiction | Status | Source |
|---|---|---|
| USUnited States | Authorised medicine | Source 2 |
| EUEuropean Union | Authorised medicine | Source 3 |
| UKUnited Kingdom | Authorised medicine | Source 9 |
| AUAustralia | Authorised medicine | Source 10 |
| CACanada | Authorised medicine | Source 11 |
Trials of Teriparatide to watch
Abaloparatide vs teriparatide in China(opens the source in a new tab)
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
Timeline
2027
2026
2003
- Approved, EU (EMA)Osteoporosis in postmenopausal women and in men at increased risk of fracture
2002
- Approved, US (FDA)Osteoporosis at high risk for fracture in postmenopausal women and men, including glucocorticoid-induced osteoporosis
Sources
- 01FORTEO (teriparatide injection) label(opens the source in a new tab)
- 02FORTEO NDA 021318: approval history(opens the source in a new tab)
- 03Forsteo (teriparatide): EPAR(opens the source in a new tab)
- 04Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis(opens the source in a new tab)
- 05Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO)(opens the source in a new tab)
- 06Teriparatide did not increase adult osteosarcoma incidence in a 15-year US postmarketing surveillance study(opens the source in a new tab)
- 07Teriparatide and osteosarcoma risk: history, science, elimination of boxed warning, and other label updates(opens the source in a new tab)
- 08Parathyroid hormone (P01270)(opens the source in a new tab)
- 09Forsteo 20 micrograms/80 microlitres solution for injection in pre-filled pen: Summary of Product Characteristics(opens the source in a new tab)
- 10TERROSA teriparatide (rbe) 250 microgram/mL solution for injection cartridge in a pre-filled pen (405710)(opens the source in a new tab)
- 11Drug Product Database: Teva-Teriparatide Injection (DIN 02486423)(opens the source in a new tab)
Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.