teriparatide
Regulatory sources consulted
Approved indications
- Osteoporosis in postmenopausal women and men at high fracture risk, and osteoporosis from prolonged systemic glucocorticoids in adults at high risk.
Contraindications
Absolute
- Hypercalcemia, severe renal impairment, Paget disease or another metabolic bone disease, unexplained alkaline phosphatase elevation, prior skeletal radiation, bone tumor, or bone metastases.
- Pregnancy, breastfeeding, or hypersensitivity.
Clinical warnings
- Major warning · Avoid in people with increased baseline osteosarcoma risk. Respect the 24-month lifetime limit. — CIMA/AEMPS, ficha técnica 85653
- Major warning · It may cause hypercalcemia, hypercalciuria, urolithiasis, and post-dose dizziness/orthostatic hypotension. — CIMA/AEMPS, ficha técnica 85653
Drug interactions
- HighDigitalis glycosides
Mechanism: The transient calcium increase may predispose to digitalis toxicity.
Recommendation: Use cautiously and monitor calcium, ECG, and toxicity.
CIMA/AEMPS, ficha técnica 85653
Adverse events
Common (≥1%)
Nausea, limb pain, headache, and dizziness
Rare but serious
Anaphylaxis and clinically significant hypercalcemia
Pregnancy and lactation
Contraindicated during pregnancy and breastfeeding. Use effective contraception and stop if pregnancy occurs.
Recent literature (PubMed)
Osteoporosis is characterized by low bone mass, increased bone fragility, and increased susceptibility to fracture, which is associated with substantial morbidity, mortality, and economic costs. Worldwide, 1 in 3 women and 1 in 5 men older than 50 years of age experience osteoporotic fractures in their lifetime. Risk factors for osteoporosis include older age, female sex, prior fractures, prior falls, low body weight, history of hip fracture in a parent, glucocorticoid use, cigarette smoking, excess alcohol consumption, certain comorbidities (eg, inflammatory bowel disease, rheumatoid arthritis, and chronic liver and kidney disease), and low level of bone mineral density (BMD; measured by dual-energy x-ray absorptiometry). The fracture risk assessment algorithm combines these clinical risk factors and BMD measurement to estimate the 10-year absolute fracture risk for hip, spine, shoulder, and forearm fractures. For patients at high risk of fracture, such as those with a T score of -2.5 or less (equivalent to a bone mass that is ≥2.5 SDs below that of young adults) for BMD, history of vertebral or hip fracture, multiple fractures, or high 10-year absolute fracture risk (eg, ≥20%), antiresorptive agents (bisphosphonates or, if contraindicated, denosumab) are recommended to reduce vertebral fractures (risk difference, -52 [95% CI, -95 to -18 per 1000 person-years]) and hip fractures (risk difference, -6 [95% CI, -11 to -1 per 1000 person-years]). Anabolic medications (teriparatide, abaloparatide, and romosozumab) should be considered in very high-risk individuals (eg, recent vertebral fractures, hip fracture with a T score of ≤-2.5 for BMD), followed by an antiresorptive agent. The use of fracture liaison services (comprehensive inpatient or outpatient management program for patients after a fracture) was shown to increase medication initiation and adherence by 38% compared with 17% for patients who did not receive fracture liaison services (risk difference, 20% [95% C
The prevalence of osteoporosis is increasing in the United States. To evaluate low bone mass and osteoporosis treatments to prevent fractures. Ovid MEDLINE ALL, Ovid Evidence Based Medicine Reviews: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and ClinicalTrials.gov from 2014 through February 2022. Adults receiving eligible interventions for low bone mass or osteoporosis. Randomized controlled trials (RCTs) for fracture outcomes, and RCTs and large observational studies (n ≥1000) for harms. Abstracted by 1 reviewer and verified by a second. Independent, dual assessments of risk of bias and certainty of evidence (CoE). We included 34 RCTs (in 100 publications) and 36 observational studies. Bisphosphonates and denosumab reduced hip, clinical and radiographic vertebral, and other clinical fractures in postmenopausal females with osteoporosis (moderate to high CoE). Bisphosphonates for 36 months or more may increase the risk for atypical femoral fractures (AFFs) and osteonecrosis of the jaw (ONJ), but the absolute risks were low. Abaloparatide and teriparatide reduced clinical and radiographic vertebral fractures but increased the risk for withdrawals due to adverse events (WAEs; moderate to high CoE). Raloxifene and bazedoxifene for 36 months or more reduced radiographic vertebral but not clinical fractures (low to moderate CoE). Abaloparatide, teriparatide, and sequential romosozumab, then alendronate, may be more effective than bisphosphonates in reducing clinical fractures for 17 to 24 months in older postmenopausal females at very high fracture risk (low to moderate CoE). Bisphosphonates may reduce clinical fractures in older females with low bone mass (low CoE) and radiographic vertebral fractures in males with osteoporosis (low to moderate CoE). Few studies examined participants with low bone mass, males, or Black-identifying persons, sequential therapy, or treatment beyond 3 years. Bisphosphonates, denosumab, abalopara
Osteoporosis in men is a common but often overlooked disorder by clinicians. The criterion for osteoporosis diagnosis in men is similar to that in women-namely, a bone mineral density (BMD) that is 2·5 standard deviations or more below the mean for the young adult population (aged 20-29 years; T-score -2·5 or lower), measured at the hip or lumbar spine. Sex steroids are important for bone health in men and, as in women, oestrogens have a key role. Most men generally have bigger and stronger bones than women and typically have less bone loss during their lifetime. Men typically fracture less often than women, although they have a higher mortality rate after a fracture. Secondary osteoporosis is more common in men than in women. Lifestyle changes, adequate calcium, vitamin D intake, and exercise programmes are recommended for the management of osteoporosis in men. Bisphosphonates, denosumab, and teriparatide have been shown to increase BMD and are used for pharmacological treatment. In this Review, we report an updated overview of osteoporosis in men, describe new treatments and concepts, and discuss persistent controversies in the area.
Postmenopausal osteoporosis is a chronic progressive disease related to estrogen deficiency at menopause, aging, and superimposed genetic and environmental factors. Many patients with osteoporosis are not diagnosed, and the majority are not treated. Current therapies for osteoporosis include antiresorptive treatments, including bisphosphonates, denosumab, and raloxifene, and osteoanabolic treatments, including teriparatide, abaloparatide, and romosozumab, which is a dual-action agent. Sequential therapies aim to optimize fracture prevention and bone density outcomes for long-term management. Recent guidelines have suggested categorical risk stratification and a goal-directed individualized therapy strategy. New treatments under investigation also hold promise for further improving bone health in postmenopausal osteoporosis.
The goal of osteoporosis management is to prevent fractures. Several pharmacological agents are available to lower fracture risk, either by reducing bone resorption or by stimulating bone formation. Bisphosphonates are the most widely used anti-resorptives, reducing bone turnover markers to low premenopausal concentrations and reducing fracture rates (vertebral by 50-70%, non-vertebral by 20-30%, and hip by ~40%). Bisphosphonates bind avidly to bone mineral and have an offset of effect measured in months to years. Long term, continuous use of oral bisphosphonates is usually interspersed with drug holidays of 1-2 years, to minimise the risk of atypical femoral fractures. Denosumab is a monoclonal antibody against RANKL that potently inhibits osteoclast development and activity. Denosumab is administered by subcutaneous injection every 6 months. Anti-fracture effects of denosumab are similar to those of the bisphosphonates, but there is a pronounced loss of anti-resorptive effect from 7 months after the last injection, which can result in clusters of rebound vertebral fractures. Two classes of anabolic drugs are now available to stimulate bone formation. Teriparatide and abaloparatide both target the parathyroid hormone-1 receptor, and are given by daily subcutaneous injection for up to 2 years. Romosozumab is an anti-sclerostin monoclonal antibody that stimulates bone formation and inhibits resorption. Romosozumab is given as monthly subcutaneous injections for 1 year. Head-to-head studies suggest that anabolic agents have greater anti-fracture efficacy and produce larger increases in bone density than anti-resorptive drugs. The effects of anabolic agents are transient, so transition to anti-resorptive drugs is required. The optimal strategy for cycling anabolics, anti-resorptives, and off-treatment periods remains to be determined.