Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-25. ← Back to Evidence Library

title: "Teriparatide: What the evidence says" slug: teriparatide status: Draft (v1), pending review by Dr. Nova Reyes (Batch F #66) last_checked: 2026-10-25 evidence_verdict: "Osteoporosis (labeled): Strong · Fracture healing: Limited (mixed results) · Gray-market: No human data" card_verdict: "Strong (osteoporosis fractures) · Fracture healing: mixed results · Gray-market: No human data" related: [abaloparatide]

Draft (v1), pending review. Not public. · ← Library · DRAFT · not published · last checked 2026-10-25

Teriparatide: what the evidence says

At a glance

What it is: recombinant human parathyroid hormone (1-34), a 34-amino-acid peptide that builds bone, sold as Forteo (also Bonsity and a generic) for osteoporosis at high fracture risk. ^{R1, R2} Gray-market sellers market it for "bone healing" after fractures.

What the evidence says: in the pivotal trial of 1,637 women with prior spine fractures, new spine fractures fell from 14% to 5% (RR 0.35) and other fragility fractures from 6% to 3%. ^R3 For speeding fracture healing, a 102-woman wrist-fracture trial missed its main goal; a secondary comparison was positive but the authors urged caution. ^R4

Biggest risks: hypercalcemia, kidney stones, dizziness on standing after early injections, and digoxin interaction. ^R1 Osteosarcoma (bone cancer) was seen in rats; FDA removed the boxed warning in 2020 after US surveillance found no increase in humans, but the label still says to avoid use in people at higher baseline risk. ^{R1, R5, R6}

Rating


Human Human evidence	Strong for postmenopausal osteoporosis fracture reduction ^R3; Limited (mixed results) for speeding fracture healing ^R4; No human data on gray-market products
Animal Animal / lab evidence	Rat osteosarcoma (label) ^R1; rodent fracture-healing benefit (cited by trial authors) ^R4
Regulatory	FDA-approved: Forteo NDA 021318 (Nov 26, 2002); Bonsity NDA 211939; generic ANDA 213641 (Amphastar, Dec 12, 2025) ^R2 · no boxed warning on current label ^R1 · WADA: not named on the 2026 List ^R7
Established human dose	For labeled use: on the FDA label ^R1. Study details lists what trials used

Evidence verdict: Osteoporosis (labeled): Strong · Fracture healing: Limited (mixed results) · Gray-market: No human data Card verdict: Strong (osteoporosis fractures) · Fracture healing: mixed results · Gray-market: No human data Card note: Not approved for fracture healing; osteosarcoma precautions remain, see page.

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: the pivotal and fracture-healing trials included Eli Lilly authors ^{R3, R4}; the osteosarcoma surveillance study was run by RTI Health Solutions with Lilly involvement. ^R5

What is it?

Taken as a short daily injection, teriparatide switches on bone-building cells more than bone-removing ones, raising bone density. ^{R1, R3} Related page: Abaloparatide.

Does it work?

Human Osteoporosis (Neer 2001): 1,637 women, median 21 months: spine fractures 5% vs 14%; spine density up 9 points more than placebo. ^R3
Human Wrist-fracture healing (Aspenberg 2010): 102 women: the higher amount did not shorten healing (primary test, p=0.52); the lower amount did in a secondary test (median 7.4 vs 9.1 weeks to bridging). ^R4

Is it safe?

Human Osteosarcoma: increased in rats; postmarketing human cases reported, but observational studies found no increased risk; limited data beyond 2 years. Avoid with open growth plates, Paget's disease, bone metastases, prior skeletal radiation or hereditary risk. ^R1
Human Surveillance: 15-year US study: 3 exposed cases vs 4.17 expected (SIR 0.72). ^R5 The boxed warning and the 2-year lifetime limit were revised in the 2020 label update. ^R6
Human Other warnings: hypercalcemia, urolithiasis, orthostatic hypotension (5% of volunteers in short studies), digoxin toxicity risk. ^R1

Gray-market "research use only" Teriparatide: extra risks

Not the approved product. "Research" teriparatide or "PTH 1-34" is not Forteo, Bonsity or the generic; identity, strength and sterility are unknown. Unknown No study has tested gray-market PTH products for fracture healing.

What we don't know

Unknown Whether teriparatide speeds healing of fractures in younger people without osteoporosis
Unknown Osteosarcoma risk beyond 2 years of use ^R1
Unknown Quality of gray-market PTH products

Is it legal?

US: FDA-approved as Forteo (NDA 021318), Bonsity (NDA 211939) and a generic (ANDA 213641) for osteoporosis at high fracture risk, including glucocorticoid-induced osteoporosis. ^{R1, R2} Not approved for fracture healing. EU, UK and others: UNVERIFIED. WADA: not named on the 2026 Prohibited List ^R7; whether a catch-all class applies: UNVERIFIED.

Study details

These are amounts researchers used, not recommendations. ### R3 Human RCT: pivotal fracture trial (Neer 2001) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Neer 2001 | 1,637 postmenopausal women with prior vertebral fracture | Subcutaneous | 20 or 40 mcg daily | Median 21 months | Vertebral fracture RR 0.35 / 0.31 | Stopped early because of the rat finding ^R6 | [PMID 11346808](https://pubmed.ncbi.nlm.nih.gov/11346808/) | ### R4 Human RCT: distal radius healing (Aspenberg 2010) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Aspenberg 2010 | 102 postmenopausal women with wrist fracture | Subcutaneous | 20 or 40 mcg daily | 8 weeks of treatment | Primary (40 mcg) not met; 20 mcg faster in post hoc | Author caution | [PMID 19594305](https://pubmed.ncbi.nlm.nih.gov/19594305/) | ### R5 Human Surveillance: osteosarcoma (Gilsenan 2021) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Gilsenan 2021 | US cancer registries, 2003–2016 | — | — | 15 years | SIR 0.72 (90% CI 0.20–1.86) | 24% interview rate | [PMID 32990990](https://pubmed.ncbi.nlm.nih.gov/32990990/) |

Full reference list (PubMed, ClinicalTrials.gov, openFDA and DailyMed entries checked Oct 25, 2026)

^R1 DailyMed. FORTEO (teriparatide) label, Eli Lilly, effective Aug 3, 2026. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=aae667c5-381f-4f92-93df-2ed6158d07b0
^R2 FDA. Drugs@FDA data (openFDA drugsfda): NDA 021318 (Forteo), 2002-11-26; NDA 211939 (Bonsity), 2019-10-04; ANDA 213641 (Amphastar), 2025-12-12; checked Oct 25, 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:teriparatide
^R3 Neer RM, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001. PMID 11346808
^R4 Aspenberg P, et al. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010. PMID 19594305
^R5 Gilsenan A, et al. Teriparatide Did Not Increase Adult Osteosarcoma Incidence in a 15-Year US Postmarketing Surveillance Study. J Bone Miner Res. 2021. PMID 32990990
^R6 Krege JH, et al. Teriparatide and Osteosarcoma Risk: History, Science, Elimination of Boxed Warning, and Other Label Updates. JBMR Plus. 2022. PMID 36111201
^R7 WADA. The 2026 Prohibited List (in force 1 January 2026). https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Teriparatide. Talk to a clinician you trust before using any drug, and report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).

Approved for Adam Greene by Dr. Nova Reyes, 2026-10-25.