Teriparatide Injection 20mg

Osteoporosis is a systemic skeletal disease characterized by significant bone loss and microarchitectural deterioration. Its major consequence is increased bone fragility, which predisposes patients to fragility fractures in the vertebrae, hip, and other sites, severely impairing quality of life and raising disability and mortality rates in the elderly. Conventional osteoporosis therapies are predominantly anti‑resorptive; while they slow bone loss, they do not fundamentally regenerate or repair bone tissue. As the only anabolic osteoporosis agent currently approved for clinical use in China, Teriparatide Injection 20mg occupies an important role in the management of osteoporosis, especially in patients at high fracture risk, providing novel clinical strategies and options.

Pharmacologically, it differs fundamentally from traditional anti‑osteoporosis medications (e.g., bisphosphonates, calcitonins). Conventional agents act as passive protective therapies that primarily inhibit bone resorption by reducing osteoclast activity to slow bone loss. In contrast, it acts as an active bone‑forming therapy: intermittent low‑dose administration preferentially stimulates osteoblast proliferation and activity, promotes new bone formation in both cancellous and cortical compartments, and moderately modulates osteoclast function. This establishes a positive balance where bone formation exceeds resorption, fundamentally increasing bone mineral density, improving bone microarchitecture, and representing its key clinical advantage over other agents.

(1) Treatment of Osteoporosis in Postmenopausal Women

Postmenopausal women experience a sharp decline in estrogen levels, leading to suppressed osteoblast activity, enhanced osteoclast activity, and rapid bone loss. They constitute a high‑risk population for osteoporosis, with a significantly higher fracture risk than men. The product is one of the first‑line treatments for such patients, especially suitable for those at high fracture risk (e.g., history of vertebral or non‑vertebral fractures, markedly reduced bone mineral density), or those intolerant or unresponsive to other anti‑osteoporosis medications.

Clinical studies have confirmed that postmenopausal women receiving daily subcutaneous injections of 20 μg the product for 12–24 months show significant increases in lumbar spine and hip bone mineral density (BMD), with lumbar spine BMD increasing by more than 9%. Meanwhile, it effectively reduces the risk of vertebral fractures by 65% and non‑vertebral fragility fractures by 53%, relieves low back pain caused by osteoporosis, and improves patients' mobility and quality of life.

Notably, although the drug significantly reduces the risk of vertebral and non‑vertebral fractures, its effect on reducing hip fracture risk has not been fully confirmed; comprehensive evaluation based on individual patient conditions is required in clinical practice.

(2) Treatment of Primary Osteoporosis in Men

Primary osteoporosis in men mostly occurs in the elderly. With aging, decreased testosterone levels, impaired nutrient absorption, reduced physical activity, and other factors jointly cause bone loss. Although fracture risk is lower than in postmenopausal women, the prognosis is poor once fractures occur. Teriparatide Injection 20mg can be used for the treatment of primary osteoporosis in men, especially those with markedly reduced BMD and high fracture risk.

A domestic phase 3, open‑label, multicenter, active‑controlled clinical trial showed that in men with osteoporosis, daily injections of 20 μg the product for 24 weeks resulted in significantly greater BMD improvement than calcitonin therapy, effectively improved bone microarchitecture, and reduced the risk of refracture. In addition, the drug was well tolerated in male patients, with no significant difference in adverse reaction rates compared with female patients; no gender‑based dose adjustment is needed.

(3) Treatment of Glucocorticoid‑Induced Osteoporosis

Long‑term use of glucocorticoids (e.g., prednisone, dexamethasone) is a major cause of secondary osteoporosis. Glucocorticoids directly inhibit osteoblast activity and promote osteoclast proliferation, leading to rapid bone loss and increased fracture risk, particularly in patients receiving long‑term immunosuppressive therapy or those with chronic inflammatory diseases (e.g., rheumatoid arthritis). The product is one of the preferred treatments for such secondary osteoporosis, effectively counteracting skeletal damage caused by glucocorticoids.

In patients with osteoporosis due to long‑term glucocorticoid use, treatment with it effectively activates osteoblasts, promotes bone formation, reverses partial bone loss, and reduces fracture risk, with superior efficacy to traditional anti‑resorptive agents. In clinical practice, the drug can be prioritized for patients on long‑term glucocorticoids with significantly reduced BMD, combined with calcium and vitamin D supplementation to further enhance therapeutic effects.

Compared with traditional anti‑osteoporosis drugs, the core advantage of it lies in its anabolic ("active bone‑forming") mechanism, which fundamentally improves bone quality rather than merely slowing bone loss. Traditional anti‑resorptive agents only produce modest BMD gains (usually ≤3%), whereas this drug increases lumbar spine BMD by more than 9% and provides superior improvement in bone microarchitecture, effectively enhancing bone toughness and strength and reducing fragility fracture risk.

In addition, the drug has a broad indication spectrum: postmenopausal women, men with primary osteoporosis, and patients with glucocorticoid‑induced secondary osteoporosis, especially those intolerant or unresponsive to other therapies, expanding clinical options. Furthermore, its convenient administration (prefilled injection pen) supports self‑administration without professional assistance, improving patient compliance. Serum calcium shows only a transient elevation after dosing; safety is favorable, with mostly mild and transient adverse reactions and high patient tolerability.