Teriparatide (Forteo) - Recombinant PTH(1-34) for Osteoporosis — Bone & Mineral
FDA-approved recombinant parathyroid hormone (PTH 1-34) for severe osteoporosis and fracture prevention - first anabolic bone agent.
Overview
Teriparatide (Forteo) is recombinant human parathyroid hormone consisting of the first 34 amino acids of PTH. FDA-approved November 2002 as the first anabolic agent for osteoporosis. Landmark Phase 3 trial (n=1,637) showed 65% reduction in vertebral fractures, 53% reduction in non-vertebral fractures, +9% lumbar spine BMD, and +3% femoral neck BMD. Unlike antiresorptive agents, teriparatide stimulates new bone formation via intermittent PTH exposure. Maximum treatment duration: 24 months (2-year lifetime limit). Indicated for postmenopausal women, men, and glucocorticoid-induced osteoporosis at high fracture risk. Requires sequential therapy with antiresorptive (bisphosphonate/denosumab) to maintain gains.
Indications
- Severe osteoporosis in postmenopausal women at high fracture risk
- Men with osteoporosis at high fracture risk
- Glucocorticoid-induced osteoporosis (men & women)
- Prior osteoporotic fractures or very low BMD (T-score ≤-2.5)
- Failed or intolerant to antiresorptive therapy
Mechanism of Action
Low bone mass, prior fractures, or failed antiresorptive therapy
Dosing
| Compound | Dose | Frequency | Notes |
|---|---|---|---|
| Teriparatide 20 mcg pre-filled pen | 20 mcg SC daily | Once daily | Inject into thigh or abdomen; rotate sites; maximum 24 months lifetime use |
| Teriparatide 20 mcg pre-filled pen | 20 mcg SC daily | Once daily | Superior to alendronate; approved 2009 for GC-induced osteoporosis |
Evidence Grade
GRADE A
Safety & Contraindications
- ⚠️ PRESCRIPTION MEDICATION - Physician supervision required
- LIFETIME LIMIT: 24 months maximum cumulative use (2-year limit)
- Former FDA boxed warning for osteosarcoma (based on rat studies) was REMOVED after 15+ years of human data showed no increased risk
- Transient hypercalcemia: Self-limiting mild elevations common; monitor calcium if symptomatic
- Orthostatic hypotension: May cause transient dizziness; inject while sitting
- CONTRAINDICATIONS: Paget's disease, unexplained elevated alkaline phosphatase, skeletal malignancies, prior radiation to skeleton, hyperparathyroidism, severe renal impairment
- NOT for children/adolescents (open growth plates)
- Common side effects: Nausea (14%), gastritis, leg cramps, dizziness
- Must refrigerate pen; expensive (~$1,000/month brand, lower for generics)