Teriparatide
approvedAlso known as: Forteo, PTH(1-34)
**Mechanism of Action** Teriparatide (recombinant human parathyroid hormone [1-34]) exerts its effects through intermittent activation of the PTH1 receptor on osteoblasts. Unlike continuous PTH exposure, which promotes bone resorption, daily subcutaneous administration of teriparatide preferentially stimulates osteoblast activity, increasing bone formation markers (e.g., P1NP, osteocalcin) and enhancing trabecular connectivity and cortical thickness. This anabolic action is mediated via upregulation of Wnt/β-catenin signaling, IGF-1, and Runx2 transcription factors, leading to improved bone mineral density (BMD) and microarchitecture. **Key Research Findings** Over 2,964 PubMed-indexed studies support teriparatide’s efficacy. The pivotal Fracture Prevention Trial (Neer et al., 2001) demonstrated a 65% reduction in vertebral fractures and 53% reduction in nonvertebral fractures in postmenopausal women with severe osteoporosis. Subsequent research confirmed its superiority over antiresorptives in increasing lumbar spine BMD (9–13% over 18–24 months) and reducing fracture risk in glucocorticoid-induced osteoporosis and hypogonadal men. Duration of therapy is limited to 24 months due to theoretical osteosarcoma risk observed in rat models, though human data show no confirmed causal link. **Clinical Relevance** Teriparatide is FDA-approved for postmenopausal women and men with severe osteoporosis (T-score ≤ -3.5 or fragility fractures), glucocorticoid-induced osteoporosis, and hypogonadal osteoporosis. It is reserved for patients at high fracture risk or those who fail/intolerant to bisphosphonates. Sequential therapy with antiresorptives (e.g., denosumab) is recommended post-treatment to maintain gains. Monitoring includes serum calcium and renal function due to transient hypercalcemia risk. For research purposes only — not medical advice.
Key data
C181H291N55O51S2Research & studies
29 osteosarcoma cases were reported among 112,798 teriparatide ICSRs; Most cases were female (72.4%) and older patients (48.3%); 96.6% were serious, with death the most common outcome (44.8%); Disproportionality versus all other drugs was significant (ROR 15.31, 95% CI 10.53-22.26; IC 3.56, 95% CI 2.95-4), consistent in the post-2006 subset; No safety signal was confirmed when teriparatide was compared with romosozumab
MACE incidence rates were 1.09 per 100 person-years for romosozumab and 1.22 per 100 person-years for teriparatide.; The adjusted hazard ratio for MACE comparing romosozumab with teriparatide was 1.00 (95% CI 0.94-1.06).; Subgroup analyses by MACE history showed no significant differences: aHR 1.01 (0.95-1.08) for no history, 0.93 (0.72-1.21) for within one year before t0, and 1.00 (0.85-1.18) for more than one year before t0.; No statistically significant difference in MACE risk was observed between romosozumab and teriparatide regardless of MACE history.
Strong evidence of superior efficacy over monotherapy existed for only 3 of 7 combinations: teriparatide+denosumab, teriparatide+zoledronic acid, and alendronate+raloxifene.; Three small studies of teriparatide plus denosumab showed significantly greater BMD increases at the lumbar spine and/or hip than either medication alone.; One large study of teriparatide plus zoledronic acid found greater lumbar spine BMD gains versus zoledronic acid alone and greater hip BMD gains versus teriparatide alone, plus reduced clinical fracture risk versus zoledronic acid alone but not versus teriparatide alone.; Evidence was insufficient for other combinations, several beneficial studies were small, and fracture outcome data were lacking.
Lumbar spine BMD percent change from baseline to 48 weeks was 8.58% for biosimilar vs 8.02% for reference, with a between-group difference of -0.56% (95% CI: -2.43% to 3.54%), within the noninferiority margin.; Femoral neck BMD percent change was 3.94% for biosimilar vs 2.50% for reference, with a between-group difference of 1.44% (95% CI: -1.44% to 4.32%), within the noninferiority margin.; Changes in serum P1NP, a pharmacodynamic marker, were similar between groups.; Safety profiles, including immunogenicity, were comparable between the biosimilar and reference teriparatide.
Abaloparatide showed advantage over teriparatide for non-vertebral fractures (OR: 0.87, 95% CI: 0.80-0.95) and hip fractures (OR: 0.81, 95% CI: 0.71-0.93).; Teriparatide and abaloparatide were superior to placebo, raloxifene, and calcitonin in reducing vertebral fractures; teriparatide was also superior to denosumab and risedronate.; For non-vertebral fractures, abaloparatide was better than any other treatment, while teriparatide was only superior to alendronate or placebo.; Both agents had comparable safety to other osteoporosis treatments, with no increased cardiovascular risk.
Hip fracture incidence was lower with abaloparatide (1.1%) vs teriparatide (1.4%) over 18 months (HR 0.83, p=0.027).; Nonvertebral fracture incidence was lower with abaloparatide (4.4%) vs teriparatide (5.0%) (HR 0.88, p=0.003).; No significant treatment-subgroup interactions were observed for age, prior antiresorptive use, or prior fracture.; Cardiovascular event rates were similar between the two treatment groups.
Weighted incidence rate difference for nonvertebral fracture was -0.08 per 100 person-years (HR 0.95, 95% CI 0.81-1.12).; Weighted incidence rate difference for hip fracture was 0.00 per 100 person-years (HR 0.99, 95% CI 0.76-1.29).; Weighted incidence rate difference for major adverse cardiac events was -0.06 per 100 person-years (HR 0.90, 95% CI 0.68-1.19).; Romosozumab and teriparatide showed comparable fracture prevention and cardiovascular safety over 365 days of follow-up.
Frequently asked questions
What is Teriparatide?
**Mechanism of Action** Teriparatide (recombinant human parathyroid hormone [1-34]) exerts its effects through intermittent activation of the PTH1 receptor on osteoblasts. Unlike continuous PTH exposure, which promotes bone resorption, daily subcutaneous administration of teriparatide preferentially stimulates osteobla
How does Teriparatide work?
Recombinant PTH(1-34) that, given intermittently, stimulates osteoblastic bone formation; approved for severe osteoporosis.
What is the research status of Teriparatide?
Teriparatide is currently classified as approved, with 3,068 research references on record. This is for research purposes only and is not medical advice.
What is the molecular weight of Teriparatide?
Teriparatide has a molecular weight of approximately 4118 g/mol (formula C181H291N55O51S2).
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