Drug updated on 9/4/2024
| 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.
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Summary
- Forteo (teriparatide) is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or for patients who have failed or are intolerant to other available osteoporosis therapies. It is also used for the increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, or for patients who have failed or are intolerant to other available osteoporosis therapies. Additionally, Forteo is indicated for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture, or for patients who have failed or are intolerant to other available osteoporosis therapies.
- This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
- Teriparatide (TPTD) significantly increased the incidence of early bone union (RR = 1.45, 95% CI [1.13, 1.87], P = 0.004) and reduced time to bone union (MD = -1.56, 95% CI [-2.86, -0.26], P = 0.02), with no significant impact on complete bone healing or progression of incomplete atypical femoral fracture (AFF) to complete AFF.
- TPTD improved bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck in men with osteoporosis and significantly increased lumbar spine and femoral neck BMD in glucocorticoid-induced osteoporosis (GIOP) patients compared to alendronate.
- TPTD reduced the risk of new vertebral fractures in GIOP patients and postmenopausal women with osteoporosis compared to bisphosphonates and decreased the incidence of vertebral fractures compared to placebo.
- TPTD enhanced alveolar bone formation in conditions such as osteonecrosis of the jaws, chronic periodontitis, and osseointegration of dental implants.
- TPTD increased the risk of withdrawals due to adverse events (WAEs) compared to placebo, with moderate to high certainty of evidence.
- There was no significant difference in adverse events between TPTD and bisphosphonates, and combination therapy with TPTD and denosumab did not show a higher incidence of adverse events compared to monotherapy.
- Common adverse effects of TPTD included arthralgia and extremity pain, with a lower incidence compared to placebo or control groups, but TPTD was associated with increased WAEs compared to bisphosphonates and denosumab.
- TPTD significantly improved BMD in men with osteoporosis, reduced vertebral fractures and increased BMD in postmenopausal women with osteoporosis, was more effective than alendronate in increasing BMD and reducing vertebral fracture risk in GIOP patients, promoted fracture healing in delayed union and nonunion fractures, and showed potential in enhancing alveolar bone regeneration in oral cavity conditions like osteonecrosis of the jaws and chronic periodontitis.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Forteo (teriparatide) Prescribing Information. | 2021 | Lilly USA LLC, Indianapolis, IN |