Peptide Graded

Abaloparatide

Does Abaloparatide work?

Yes, in large controlled trials: 2,463 women were followed for 18 months.

AStrong human evidenceFDA approvedas of 2026-10-26

Approval for osteoporosis rests on ACTIVE, a randomized, double-blind, placebo- and active-controlled phase 3 trial in 2,463 postmenopausal women with fracture endpoints, plus the ATOM trial in 228 men with a bone-density endpoint. Fracture reduction in women was shown directly; the men's approval relies on bone density as a surrogate. 56

The ACTIVE trial randomized 2,463 postmenopausal women with osteoporosis. They got abaloparatide, placebo or open-label teriparatide for 18 months. New spine fractures hit 0.58% of women on abaloparatide and 4.22% on placebo. Non-spine fractures hit 2.7% versus 4.7%. Bone mineral density rose at the spine, hip and femoral neck, compared with placebo. 5

Next to teriparatide, abaloparatide gave bigger gains in total hip and femoral neck density at 18 months. It also caused less hypercalcemia (3.4% versus 6.4%). Fracture rates did not differ significantly between the two drugs. 5

Evidence checklist

  • Randomised controlled trial ACTIVE, placebo and teriparatide controlled
  • Human study over 100 people ACTIVE 2,463 women; ATOM 228 men
  • More than one research group Sponsor-run trials; no independent replication cited
  • Clinical outcomes, not surrogate markers Fracture reduction in women
  • Human safety data beyond case reports Phase 3 safety plus label warnings

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More on Abaloparatide

Citations

  1. StatPearls: Abaloparatide ncbi.nlm.nih.gov
  2. PMC review: PTH1 receptor pharmacology of abaloparatide pmc.ncbi.nlm.nih.gov
  3. StatPearls: Physiology, bone remodeling ncbi.nlm.nih.gov
  4. NIAMS: Bone mineral density tests, what the numbers mean niams.nih.gov
  5. Miller 2016, JAMA: ACTIVE trial of abaloparatide vs placebo in postmenopausal osteoporosis jamanetwork.com
  6. FDA: Tymlos (abaloparatide) prescribing information, 2024 accessdata.fda.gov
  7. Radius Health: Tymlos product site tymlos.com
  8. Biochemical Pharmacology 2019: abaloparatide, a first-in-class PTHrP analog sciencedirect.com

Reference information only, not medical advice. Drawn from the Abaloparatide article, fact-checked against the cited sources. No dosing anywhere on this site.