Drug updated on 4/23/2024
| Dosage Form | Injection (subcutaneous; 600 mcg/2.4 mL [250 mcg/mL]) |
| Drug Class | Parathyroid hormone analogs |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
- Indicated for the increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
- Indicated for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
Summary
- Teriparatide (Forteo) is indicated for the treatment of osteoporosis in postmenopausal women, men with primary or hypogonadal osteoporosis, and individuals undergoing sustained systemic glucocorticoid therapy. It has demonstrated significant efficacy in increasing bone mineral density (BMD) and reducing fracture risk.
- The study was based on 17 systematic reviews/meta-analyses that compared teriparatide's safety and effectiveness to other treatments for osteoporosis.
- Teriparatide significantly accelerated early bone union and reduced time to bone union in cases of atypical femoral fractures compared to controls. This suggests its potential role in promoting callus formation and aiding the healing of delayed/non-healing fractures.
- Compared to bisphosphonates, which have been associated with serious side effects such as atypical femoral fractures (AFF) and osteonecrosis of the jaw (ONJ), teriparatide showed fewer adverse events while fostering direct anabolic effects on bones.
- Combination therapy involving teriparatide with denosumab proved more effective than monotherapy by enhancing BMD at the lumbar spine & hip without an increased incidence of adverse events; this indicates a synergistic effect when used together.
- Some studies suggest romosozumab might offer better improvements in BMD than teriparatide, but both had comparable risks regarding serious adverse events.
- In terms of the safety profile, most studies reported very few or no severe negative side effects from using Forteo; common mild symptoms included pain at the injection site, though it did increase withdrawal rates due to these adversities especially when compared against bisphosphonates/denosumab use.
- For specific populations: Postmenopausal women saw reductions in vertebral/nonvertebral fracture risks under Forteo treatment - similar benefits were seen among men suffering from osteoporosis, indicating gender-neutral advantages offered by this drug.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Forteo (teriparatide) Prescribing Information. | 2021 | Lilly USA LLC, Indianapolis, IN |