Teriparatide

Teriparatide is best known for building new bone - unlike most osteoporosis drugs, which just slow bone loss, teriparatide actively grows it, given as a small once-daily injection. It's a lab-made copy of the active part of parathyroid hormone (the first 34 amino acids). It's an FDA-approved prescription medicine (brand names include Forteo and Bonsity), not a research chemical, used for people with osteoporosis at high risk of fracture.

Teriparatide builds bone, and it's an FDA-approved osteoporosis drug (parathyroid hormone 1-34). Its approval rests on a large randomized trial: in 1,637 postmenopausal women with prior spine fractures, once-daily self-injected teriparatide reduced the risk of new spine fractures by roughly two-thirds and roughly halved new non-spine fragility fractures versus placebo over a median of 21 months, while increasing bone density at the spine and hip. Side effects were minor: occasional nausea and headache. This is high-quality human evidence, which sets teriparatide apart from the preclinical-only peptides in this library.

FDA-approved prescription drug (approved 2002 as Forteo; generic teriparatide and Bonsity also approved). Indicated for osteoporosis at high fracture risk in postmenopausal women and men, and for glucocorticoid-induced osteoporosis. This is a genuine prescription medicine — distinct from the research-only peptides elsewhere in this library. WADA status: Not prohibited. Teriparatide (PTH 1-34) is a bone-anabolic hormone and is not listed on the WADA Prohibited List; however, athletes should always verify the current list. Not DEA-scheduled (prescription, non-controlled). Historically carried a boxed warning about osteosarcoma (bone cancer) seen in rats; the FDA removed the boxed warning and the 2-year lifetime-use limit in 2020, though caution in patients at increased osteosarcoma risk remains in labeling.

Teriparatide is a prescription medicine that should be used under medical supervision. It can cause transient increases in blood calcium, dizziness on standing, leg cramps, nausea, and headache. It is not recommended for people at increased risk of osteosarcoma (for example, prior skeletal radiation, Paget's disease of bone, or unexplained high alkaline phosphatase). It is not on the WADA Prohibited List, but athletes should verify the current list. VialWise is a research and educational reference, not medical advice — teriparatide use should be directed by a licensed clinician.

⚠️ For research and educational purposes only (this entry). This entry is informational and not medical advice or a substitute for the FDA-approved prescribing information. Always confirm dose calculations with the in-app calculator and follow your prescriber's instructions and the product labeling.

⚠️ Osteosarcoma history. Rats given high, near-lifelong doses of teriparatide developed osteosarcoma (a bone cancer), which drove a boxed warning and a 2-year lifetime-use limit for years. The FDA removed the boxed warning and the lifetime limit in 2020, but labeling still advises caution in people at increased baseline risk of osteosarcoma. This is a real regulatory history worth understanding.

Teriparatide is a recombinant human parathyroid hormone fragment, PTH(1-34) — the first 34 amino acids of the 84-amino-acid natural parathyroid hormone, which retain its biological activity on bone. It is a genuine, FDA-approved prescription osteoporosis drug, first approved in 2002 as Forteo (Eli Lilly); a generic teriparatide and the branded Bonsity have since been approved as well.

Why "anabolic." Continuously elevated parathyroid hormone (as in hyperparathyroidism) pulls calcium *out* of bone. But given as a small once-daily pulse, PTH(1-34) has the opposite net effect: it preferentially stimulates osteoblasts (bone-forming cells) over osteoclasts, producing net new bone formation. This makes teriparatide one of the few bone-anabolic osteoporosis treatments, in contrast to the more common antiresorptive drugs (bisphosphonates, denosumab) that primarily slow bone breakdown.

Pivotal evidence. Teriparatide's approval rests on a large, high-quality randomized trial. According to PubMed, Neer and colleagues (2001) randomized 1,637 postmenopausal women with prior vertebral fractures to daily self-injected PTH(1-34) at 20 or or placebo, over a median of 21 months.[¹] New vertebral fractures occurred in 14% of the placebo group versus 5% and 4% — relative risks of roughly 0.35 and 0.31. New nonvertebral fragility fractures were roughly halved (relative risk ~0.47). BMD rose by ~9 and ~13 percentage points at the lumbar spine versus placebo, and at the femoral neck. Side effects were minor — occasional nausea and headache. The dose raised BMD more but had similar fracture benefit and more side effects, which is why became the approved dose.[¹] This is a genuine fracture-outcomes trial — a much stronger evidence base than the surrogate-endpoint or preclinical data behind most research peptides.

Approved indications (FDA labeling). Teriparatide is indicated for postmenopausal women with osteoporosis at high risk of fracture, to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk, and for glucocorticoid-induced osteoporosis at high fracture risk. It is typically reserved for high-risk patients or those who have failed or cannot tolerate other therapies. After a course of teriparatide, an antiresorptive agent is usually started to preserve the gains.

Regulatory status (US). FDA-approved prescription drug (2002). Not DEA-scheduled (prescription but not a controlled substance). The former boxed warning about osteosarcoma and the 2-year lifetime-use limit were removed by the FDA in 2020; labeling still advises against use in patients at increased baseline osteosarcoma risk.

Regulatory status (sport — WADA). Teriparatide (PTH 1-34) is a bone-anabolic hormone and is not listed on the WADA Prohibited List. It is not a performance-enhancing category. Athletes should nonetheless verify the current WADA Prohibited List and consult their National Anti-Doping Organization, as list details can change.

Common uses. Osteoporosis at high fracture risk (its approved use). It is also used off-label by clinicians for selected difficult fracture-healing scenarios, though that use is not an approved indication.

Commonly reported

• Nausea and headache (the most commonly noted in the pivotal trial)
• Orthostatic hypotension — transient dizziness/lightheadedness on standing, typically in the first few doses
• Leg cramps
• Transient hypercalcemia — a mild, usually transient rise in blood calcium after dosing; transient increases in serum uric acid can also occur
• Injection-site reactions

Serious

• Osteosarcoma — seen in rats at high lifetime doses; drove a former boxed warning (removed 2020). Caution in patients at increased baseline osteosarcoma risk.
• Symptomatic hypercalcemia — uncommon; more likely with predisposing conditions.

Increased risk of osteosarcoma — avoid in Paget's disease of bone, unexplained elevated alkaline phosphatase, open epiphyses (young patients), prior skeletal radiation, or bone metastases/skeletal malignancy

Pre-existing hypercalcemia (e.g., primary hyperparathyroidism) — contraindicated

Severe renal impairment — use with caution

Pregnancy and lactation — not established; use only if clearly needed and directed by a clinician

Pediatric / young adults with open growth plates — contraindicated

Known hypersensitivity to teriparatide or excipients — contraindicated

Regulatory note (US): FDA-approved prescription drug; should be obtained and used by prescription. Not DEA-scheduled.

Regulatory note (sport): Not listed on the WADA Prohibited List; verify the current list and consult your anti-doping organization.

Parathyroid hormone (PTH)

A natural hormone that regulates calcium and bone turnover. Teriparatide is the first 34 amino acids of PTH, which retain its bone-building activity.

Anabolic (bone)

Bone-building. Teriparatide stimulates the formation of new bone, in contrast to "antiresorptive" drugs that mainly slow bone breakdown.

Vertebral fracture

A fracture of a spinal bone, a common and serious consequence of osteoporosis. Reducing these was the main endpoint of the pivotal trial.

Bone mineral density (BMD)

A measure of how much mineral (mostly calcium) is in bone, used to assess osteoporosis and treatment response.

Osteosarcoma

A type of bone cancer. It was seen in rats given high, lifelong doses of teriparatide, which drove a former boxed warning; the FDA removed that warning in 2020.

1. Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH. (2001). Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. The New England Journal of Medicine, 344(19):1434–1441.(PMID 11346808)

• Abaloparatide — same mechanism class