Drug that stimulates bone formation. Used in osteoporosis with high fracture risk.
Regulatory status
Approved (FDA / EMA)
Family
PTH-related protein (PTHrP) analog
Scientific evidence
High
Number of findings
2
Where it acts
Bones and muscles · Hormones and metabolism
Also known as
abaloparatide, Tymlos, Eladynos, BA058
Regulatory status
FDA (US): Approved (2017, Tymlos) for postmenopausal women with osteoporosis at high risk of fracture; expanded in 2022 to men with osteoporosis at high risk of fracture.
EMA (EU): Rejected in 2018–2019 (doubts about non-vertebral fractures and cardiac effects); later approved (2022, Eladynos) only for postmenopausal women with osteoporosis and increased risk of fracture.
Dose
80 µg subcutaneously once a day, for a maximum of 18 months (FDA Tymlos and EMA Eladynos labels), with calcium and vitamin D if the diet is insufficient.
Safety
Dizziness and a drop in blood pressure on standing (administer seated or lying down the first few times), palpitations and tachycardia, nausea, headache, rises in calcium and uric acid. Do not use in children or young people with growing bones, Paget's disease, or at risk of osteosarcoma. Only with a prescription.
Interactions
Caution with drugs that lower blood pressure or cause orthostatic hypotension; with digoxin, hypercalcemia may favor toxicity.
Differences between women and men
In the EU it is approved only for postmenopausal women; in the US also for men since 2022. In men, an RCT showed bone density gains similar to those in women. Not indicated in pregnancy or in women who could become pregnant. View the study →
Effect by goal · level of evidence
Fewer vertebral fractures after menopause
reducesHighRCT (AA)in people
Fewer fractures vs placebo
ACTIVE trial with 2,463 women over 18 months: fewer new vertebral and non-vertebral fractures than with placebo and greater bone density gain in the hip and spine. Less hypercalcemia than with teriparatide (3.4% vs 6.4%).
It activates the PTH receptor (PTH1R) intermittently, with one daily injection. This brief stimulus makes osteoblasts build new bone faster than it is broken down. It increases bone mineral density and reduces fractures.
What the evidence says
In people
Fewer vertebral fractures after menopause. ACTIVE trial with 2,463 women over 18 months: fewer new vertebral and non-vertebral fractures than with placebo and greater bone density gain at the hip and spine. Less hypercalcemia than with teriparatide (3.4% vs 6.4%). PubMed 27533157
Bone density in men with osteoporosis. ATOM RCT with 228 men over 12 months: spine bone density +8.5% versus +1.2% with placebo, and total hip +2.1% versus 0%. PubMed 36190391