Teriparatide

Summary

Teriparatide (rhPTH 1-34) is an anabolic bone agent approved for the treatment of osteoporosis in postmenopausal women, men with primary or hypogonadal osteoporosis, and glucocorticoid-induced osteoporosis at high fracture risk. It is the first approved anabolic therapy for osteoporosis and stimulates new bone formation rather than merely inhibiting resorption.

Mechanism of Action

Recombinant human parathyroid hormone fragment (1-34) that binds to the PTH/PTHrP receptor on osteoblasts and osteoclasts, stimulating new bone formation by preferentially activating osteoblastic activity over osteoclastic resorption when administered intermittently, increasing bone mineral density and improving bone microarchitecture.

Routes of Administration

Goals & Uses

• Treatment of male osteoporosisBone HealthModerate
• Treatment of glucocorticoid-induced osteoporosisBone HealthHigh
• Increase in bone mineral densityBone HealthHigh
• Reduction of vertebral fracture riskBone HealthHigh
• Reduction of nonvertebral fracture riskBone HealthHigh
• Fracture healingBone RepairLow

Contraindications

• Prior radiation therapy involving the skeletonOncologicHigh
• HypercalcemiaMetabolic DisorderHigh
• Severe renal impairmentOrganModerateKidney function concerns
• Pediatric patients with open epiphysesPediatricHigh
• Paget's disease of boneBone DisorderHigh
• Osteosarcoma or prior skeletal malignancyOncologicHigh

Adverse Effects

• Dizziness/orthostatic hypotensionCardiovascularCommon
• HypercalcemiaMetabolicUncommon
• Injection site reactionsLocalCommon
• HypercalciuriaMetabolicCommon
• NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
• Leg crampsMusculoskeletalCommon

Drug Interactions

• DigoxinHigh
• Calcium supplements and vitamin DLow
• Antiresorptive agents (bisphosphonates)Moderate
• Thiazide diureticsModerate

Population Constraints

• PregnancyReproductive SafetyAbsolute
• Patients with prior osteosarcomaOncologicAbsolute
• Pediatric patientsAgeAbsolute
• Patients with active urolithiasisUrologicRelative
• Severe renal impairment (CrCl <30 mL/min)Organ ImpairmentRelative

Regulatory Status

• European UnionApprovedApproved: Treatment of osteoporosis in postmenopausal women, Treatment of osteoporosis in men at increased risk of fracture, Treatment of glucocorticoid-induced osteoporosis in men and postmenopausal womenEMA approved 2003 (Forsteo). Biosimilars approved (Terrosa, Movymia). Duration of use limited to 24 months over a lifetime in EU label.
• United StatesApprovedApproved: Postmenopausal osteoporosis at high fracture risk, Male osteoporosis at high fracture risk, Glucocorticoid-induced osteoporosis in men and women at high fracture riskFDA approved 2002. Boxed warning for osteosarcoma removed January 2020; 2-year treatment limit also removed at that time.
• United KingdomApprovedApproved: Postmenopausal osteoporosis, Male osteoporosis, Glucocorticoid-induced osteoporosisMHRA approved; post-Brexit maintains EU-era approval. NICE guidance recommends for severe osteoporosis in postmenopausal women.

Originally limited to a 24-month lifetime treatment course due to osteosarcoma risk observed in rat studies; FDA removed the boxed warning and 2-year duration limit in January 2020 based on post-marketing safety data. Black box warning on osteosarcoma was previously included.

Evidence & Sources

No sources recorded yet.