We use essential cookies (authentication, your saved goals/stack) by default. With your permission we'll also enable privacy-respecting analytics (Vercel Web Analytics, anonymous load-time metrics) and error-replay diagnostics (Sentry — DOM snapshots only when an error fires) so we can fix bugs faster. Learn more about cookies
Aba6.0
Abaloparatide Research
Mostly mechanism / observationalLimited safety
11 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Abaloparatide studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from medium-quality meta-analyses and randomised trials published 2016–2025 with a typical study size of 982 participants.
Based on 11 studies · 3 meta-analyses · 5 RCTs · 4,835 total participants
Confidence
High
By outcome
Bone density & anabolic bone formation
Mostly mechanism / observational10 studies
Fracture & skeletal endpoints
Mostly mechanism / observational5 studies
Safety profile
Mostly mechanism / observational4 studies
Active research area
5 studies in the last 5 years · Latest meta-analysis: 2025
20162025
1RCTn=2,463 · very large study2016
Among postmenopausal women with osteoporosis, the use of subcutaneous abaloparatide, compared with placebo, reduced the risk of new vertebral and nonvertebral fractures over 18 months.
Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators. · JAMA (2016)
Pivotal phase-3, double-blind ACTIVE RCT (n=2463 postmenopausal women, mean age 69) randomized to abaloparatide 80 µg/day, placebo, or open-label teriparatide 20 µg/day subcutaneously for 18 months
Abaloparatide is a selective activator of the PTH type-1 receptor; new morphometric vertebral fractures occurred far less frequently than placebo (~86% relative reduction) and nonvertebral fractures were also reduced
BMD increases were greater with abaloparatide than placebo at all sites (all P<0.001)
During the full 43-month treatment period, 0.9% of evaluable women in the ABL/ALN group experienced a new radiographic vertebral fracture vs 5.6% of women in the PBO/ALN group, an 84% relative risk reduction.
Bone HG, Cosman F, Miller PD, Williams GC, Hattersley G, Hu MY, Fitzpatrick LA, Mitlak B, Papapoulos S, Rizzoli R, Dore RK, Bilezikian JP, Saag KG. · J Clin Endocrinol Metab (2018)
Extension of ACTIVE: women who completed abaloparatide (ABL) or placebo (PBO) received up to 24 months of alendronate (ALN); 558 ABL and 581 PBO completers enrolled
Over the full 43 months, vertebral fracture was reduced 84% with ABL/ALN vs PBO/ALN (P<0.001); BMD gains from the anabolic phase were preserved and increased further during the antiresorptive phase
Kaplan-Meier rates for other fracture types were significantly lower with ABL/ALN; a regulatory supplemental analysis found no hip fractures in ABL/ALN vs five in PBO/ALN
Bone anabolic treatments were more effective than bisphosphonates in the prevention of clinical and vertebral fractures, irrespective of baseline risk indicators.
Händel MN, Cardoso I, von Bülow C, Rohde JF, Ussing A, Nielsen SM, Christensen R, Body JJ, Brandi ML, Diez-Perez A, Hadji P, Javaid MK, Lems WF, Nogues X, Roux C, Minisola S, Kurth A, Thomas T, Prieto-Alhambra D, Ferrari SL, Langdahl B, Abrahamsen B. · BMJ (2023)
Systematic review, network meta-analysis and meta-regression of 69 trials (>80,000 postmenopausal women), including the bone anabolic agents abaloparatide and romosozumab
Parathyroid-hormone-receptor agonists (abaloparatide/teriparatide) and romosozumab protected against clinical fractures vs placebo; bisphosphonates were less effective than PTH-receptor agonists (OR 1.49)
PTH-receptor agonists, denosumab and romosozumab were more effective than oral bisphosphonates for vertebral fractures; no harm signals seen, certainty moderate-to-low
At 12 months, BMD gains were greater with abaloparatide compared with placebo at the lumbar spine (8.48 versus 1.17), total hip (2.14 versus 0.01), and femoral neck (2.98 versus 0.15) (all p<0.0001).
Czerwinski E, Cardona J, Plebanski R, Recknor C, Vokes T, Saag KG, Binkley N, Lewiecki EM, Adachi J, Knychas D, Kendler D, Orwoll E, Chen Y, Pearman L, Li YH, Mitlak B. · J Bone Miner Res (2022)
ATOM phase-3 RCT (n=228 men aged 40-85 with osteoporosis) randomized 2:1 to abaloparatide 80 µg/day or placebo subcutaneously for 12 months; primary endpoint was lumbar-spine BMD
Significantly greater BMD gains with abaloparatide at lumbar spine (~8.5% vs ~1.2%), total hip and femoral neck (all P<0.0001)
Most common adverse events were injection-site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension and headache — consistent with prior studies
Abaloparatide showed an advantage over teriparatide for non-vertebral fractures (OR: 0.87, 95% CI: 0.80-0.95) and hip fractures (OR: 0.81, 95% CI: 0.71-0.93).
Beaudart C, Veronese N, Douxfils J, Thiyagarajan JA, Bolzetta F, Albanese P, Voltan G, Alokail M, Harvey NC, Fuggle NR, Bruyère O, Rizzoli R, Reginster JY. · Osteoporos Int (2025)
Systematic review and Bayesian network meta-analysis of PTH1-receptor agonists (17 studies: 11 RCTs, 6 real-world-evidence) up to May 2024
Teriparatide and abaloparatide both reduced vertebral and nonvertebral fractures vs placebo; abaloparatide had an advantage over teriparatide for nonvertebral (OR 0.87) and hip (OR 0.81) fractures
Both PTH1 analogs were superior to placebo, raloxifene and calcitonin for vertebral fracture; both showed acceptable safety with no increased cardiovascular risk
Abaloparatide and teriparatide reduced clinical and radiographic vertebral fractures but increased the risk for withdrawals due to adverse events (moderate to high CoE).
Ayers C, Kansagara D, Lazur B, Fu R, Kwon A, Harrod C. · Ann Intern Med (2023)
Living systematic review and network meta-analysis for the ACP (34 RCTs in 100 publications + 36 observational studies)
Abaloparatide and teriparatide reduced clinical and radiographic vertebral fractures (moderate-to-high certainty) but increased withdrawals due to adverse events
Abaloparatide, teriparatide, and sequential romosozumab-then-alendronate may be more effective than bisphosphonates in reducing clinical fractures over 17-24 months in very-high-risk older postmenopausal women
At months 6, 12, and 18, there were significantly more >3% BMD responders in the abaloparatide group compared with placebo and teriparatide: month 18, 44.5% vs 1.9% and 32.0% (P<0.001).
Miller PD, Hattersley G, Lau E, Fitzpatrick LA, Harris AG, Williams GC, Hu MY, Riis BJ, Russo L, Christiansen C. · Bone (2019)
Prespecified BMD responder analysis from the ACTIVE phase-3 trial; abaloparatide selectively binds the RG conformation of the PTH type-1 receptor
Significantly more patients reached >3% BMD gains at all three sites with abaloparatide than placebo or teriparatide (44.5% vs 1.9% vs 32.0% at 18 months)
Findings were consistent across >0%, >3% and >6% responder thresholds
Ultradistal radius BMD changes from baseline were 2.25 percentage points greater for abaloparatide compared with placebo... and 1.54 percentage points greater for abaloparatide compared with teriparatide.
Watts NB, Hattersley G, Fitzpatrick LA, Wang Y, Williams GC, Miller PD, Cosman F. · Osteoporos Int (2019)
Exploratory ACTIVE analysis (forearm BMD subset n=982; wrist fractures in the full n=2463) comparing abaloparatide vs placebo and teriparatide
Abaloparatide increased ultradistal radius (trabecular-rich) BMD more than placebo and teriparatide, and lost less cortical (1/3 radius) BMD than teriparatide
Numerically lower wrist-fracture incidence with abaloparatide vs teriparatide (HR 0.43, P=0.052) and placebo (HR 0.49)
Treatment with abaloparatide for 3 months stimulated bone formation on cancellous, endocortical, intracortical, and periosteal envelopes in transiliac bone biopsies.
Dempster DW, Zhou H, Rao SD, Recknor C, Miller PD, Leder BZ, Annett M, Ominsky MS, Mitlak BH. · J Bone Miner Res (2021)
Open-label single-arm histomorphometry study (n=23 postmenopausal women) with paired double-fluorochrome-labeled transiliac biopsies before and after 3 months of abaloparatide 80 µg/day
Mineralizing surface and bone-formation rate increased significantly on all four bone envelopes (cancellous, endocortical, intracortical, periosteal)
Modeling-based (de novo) formation accounted for a substantial share of the new bone-forming surface, with serum turnover markers tracking the histomorphometric changes
Abaloparatide is recombinant human parathyroid hormone-related peptide 1-34... an anabolic agent that appears more potent than teriparatide, and it may have more rapid onset of fracture reduction than teriparatide.
Chew CK, Clarke BL. · Maturitas (2017)
Narrative review of abaloparatide as a PTHrP(1-34) anabolic osteoporosis therapy, contextualizing it against teriparatide (the previously sole approved anabolic agent)
Describes the anabolic (bone-formation-stimulating) mechanism and the possibility of more potent, more rapid fracture reduction than teriparatide
Written during FDA review, anticipating 2017 approval — establishes the PTHrP-analog identity and class framing
Near life-long treatment with abaloparatide in rats resulted in dose and time dependent formation of osteosarcomas, with a comparable response to hPTH(1-34) at similar exposure.
Jolette J, Attalla B, Varela A, Long GG, Mellal N, Trimm S, Smith SY, Ominsky MS, Hattersley G. · Regul Toxicol Pharmacol (2017)
2-year rat carcinogenicity study: Fischer F344 rats given daily subcutaneous abaloparatide (10/25/50 µg/kg) or hPTH(1-34) 30 µg/kg as positive control
Abaloparatide produced dose- and time-dependent osteosarcomas comparable to PTH(1-34) at similar human-exposure multiples; no increase in non-bone tumors
This rat finding is the HISTORICAL basis of the original osteosarcoma boxed warning and 2-year use limit — both later removed by the FDA (2020-2021) given rat-specific mechanism and absence of a human signal