Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-25. ← Back to Evidence Library

title: "Abaloparatide: What the evidence says" slug: abaloparatide status: Draft (v1), pending review by Dr. Nova Reyes (Batch F #67) last_checked: 2026-10-25 evidence_verdict: "Osteoporosis (labeled): Strong · Gray-market use: No human data" card_verdict: "Strong (osteoporosis fractures) · Gray-market: No human data" related: [teriparatide]

Draft (v1), pending review. Not public. · ← Library · DRAFT · not published · last checked 2026-10-25

Abaloparatide: what the evidence says

At a glance

What it is: a 34-amino-acid analog of parathyroid hormone-related protein (PTHrP 1-34), sold as Tymlos for osteoporosis at high fracture risk in postmenopausal women and men. ^{R1, R2}

What the evidence says: in the ACTIVE trial (2,463 women, 18 months) it reduced new spine and non-spine fractures compared with placebo, and caused less high blood calcium than teriparatide (3.4% vs 6.4%). ^R3

Biggest risks: osteosarcoma in rats (unknown in humans; avoid in people at higher baseline risk), dizziness on standing within 4 hours of injection, hypercalcemia, and kidney stones. ^R1

Rating


Human Human evidence	Strong for postmenopausal osteoporosis fracture reduction ^R3; No human data on gray-market products
Animal Animal / lab evidence	Dose-dependent rat osteosarcoma (label) ^R1
Regulatory	FDA-approved: Tymlos NDA 208743 (Apr 28, 2017) ^R2 · no boxed warning on current label ^R1 · WADA: not named on the 2026 List ^R4
Established human dose	For labeled use: on the FDA label ^R1. Study details lists what trials used

Evidence verdict: Osteoporosis (labeled): Strong · Gray-market use: No human data Card verdict: Strong (osteoporosis fractures) · Gray-market: No human data Card note: Osteosarcoma precautions, see page.

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: ACTIVE was run by the developer, Radius Health (several authors employed by Radius). ^R3

What is it?

Abaloparatide activates the same receptor as teriparatide (PTH1R) but was designed to favor bone building with less calcium release. ^{R1, R3} Related page: Teriparatide.

Does it work?

Human ACTIVE: 2,463 women, 1,901 completed: fewer new vertebral and nonvertebral fractures vs placebo; larger bone density gains (all P<.001). ^R3 Exact fracture rates: see paper (not in abstract).

Is it safe?

Human Osteosarcoma: dose-dependent in rats at 4–28 times human exposure; unknown in humans; limited data beyond 2 years. ^R1
Human Orthostatic hypotension (within 4 hours), hypercalcemia, hypercalciuria and kidney stones. ^R1
Human ACTIVE: hypercalcemia 3.4% vs 6.4% on teriparatide. ^R3

Gray-market "research use only" Abaloparatide: extra risks

Not the approved product. "Research" abaloparatide is not Tymlos; identity, strength and sterility are unknown.

What we don't know

Unknown Head-to-head fracture superiority over teriparatide (ACTIVE was not designed for it) ^R3
Unknown Quality of gray-market products

Is it legal?

US: FDA-approved as Tymlos (NDA 208743) for postmenopausal women and men with osteoporosis at high fracture risk. ^{R1, R2} EU, UK and others: UNVERIFIED. WADA: not named on the 2026 Prohibited List. ^R4

Study details

These are amounts researchers used, not recommendations. ### R3 Human RCT: ACTIVE (Miller 2016) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Miller 2016 | 2,463 postmenopausal women with osteoporosis | Subcutaneous | 80 mcg daily (vs placebo or open-label teriparatide 20 mcg) | 18 months | Fewer vertebral and nonvertebral fractures; hypercalcemia 3.4% vs 6.4% | Radius-funded | [PMID 27533157](https://pubmed.ncbi.nlm.nih.gov/27533157/) · [NCT01343004](https://clinicaltrials.gov/study/NCT01343004) |

Full reference list (PubMed, ClinicalTrials.gov, openFDA and DailyMed entries checked Oct 25, 2026)

^R1 DailyMed. TYMLOS (abaloparatide) label, Radius Health, effective Aug 11, 2026. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=712143d9-e21e-4013-bb3b-3426a21060a8
^R2 FDA. Drugs@FDA data (openFDA drugsfda), NDA 208743 (Tymlos), original approval 2017-04-28, checked Oct 25, 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:abaloparatide
^R3 Miller PD, et al. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial. JAMA. 2016. PMID 27533157
^R4 WADA. The 2026 Prohibited List (in force 1 January 2026). https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Abaloparatide. Talk to a clinician you trust before using any drug, and report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).

Approved for Adam Greene by Dr. Nova Reyes, 2026-10-25.