Clinical Trials

Abaloparatide has been evaluated in numerous clinical trials investigating its efficacy and safety across diverse skeletal disorders, primarily targeting postmenopausal osteoporosis, age-related bone loss, spinal fusion, pelvic fractures, and femoral fractures. These investigations span Phase 1 through Phase 4 clinical studies, reflecting progression from bioequivalence evaluations to post-marketing observational assessments. Research is sponsored by both pharmaceutical entities, such as Radius Health and Qilu Pharmaceutical, and major academic medical centers, including the Hospital for Special Surgery and the State University of New York at Buffalo. Recruitment statuses across these trials range from completed and active recruiting to enrolled by invitation or withdrawn, underscoring the ongoing therapeutic evaluation of this agent in enhancing bone repair and density.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07616401 RECRUITING
Osteoporosis; Menopause
Istituto Auxologico Italiano
 2025-08-31
NCT07587775 ENROLLING_BY_INVITATION
Lumbar Degenerative Disease
State University of New York at Buffalo
 2026-06-18 PHASE2
NCT06898060 NOT_YET_RECRUITING
Postmenopausal Women With Osteoporosis
Qilu Pharmaceutical Co., Ltd.
 2025-06 PHASE3
NCT03841058 ACTIVE_NOT_RECRUITING
Spinal Fusion
Hospital for Special Surgery, New York
 2019-08-14 PHASE2
NCT04467983 ACTIVE_NOT_RECRUITING
Osteoporosis, Postmenopausal
Hospital for Special Surgery, New York
 2021-02-01 PHASE4
NCT04626141 WITHDRAWN
Femoral Fractures
Daniel Horwitz
 2024-06 PHASE4
NCT04167163 COMPLETED
Osteoporosis; Arthroplasties, Knee Replacement
University of Wisconsin, Madison
 2020-01-10 PHASE4
NCT04249232 COMPLETED
Fracture of Pelvis (Disorder)
Hospital for Special Surgery, New York
 2020-09-17 PHASE2
NCT04760782 TERMINATED
Odontoid Fracture
David Lunardini
 2022-05-18 PHASE2
NCT03708926 WITHDRAWN
Degeneration Disc Intervertebral
Johns Hopkins University
 2021-03 PHASE2
NCT03746041 COMPLETED
Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia
University of Rochester
 2019-02-14 PHASE1
NCT04064411 COMPLETED
Postmenopausal Osteoporosis
Radius Health, Inc.
 2019-08-05 PHASE3
NCT03512262 COMPLETED
Osteoporosis; Osteoporosis, Age-Related; Osteoporosis Localized to Spine; Age Related Osteoporosis; Osteoporosis Senile; Osteoporosis of Vertebrae
Radius Health, Inc.
 2018-05-03 PHASE3
NCT04663464 COMPLETED
Healthy Volunteers
Radius Health, Inc.
 2020-11-16 PHASE1
NCT04936984 COMPLETED
Osteoporosis
Radius Health, Inc.
 2020-11-16 PHASE1
NCT03710889 COMPLETED
Osteoporosis, Postmenopausal; Osteoporosis; Osteoporosis Vertebral; Osteoporosis Risk; Osteoporosis Fracture; Osteoporosis Localized to Spine; Osteoporosis, Age-Related; Osteoporosis Senile; Osteoporosis of Vertebrae
Radius Health, Inc.
 2018-09-20 PHASE3
NCT04366726 COMPLETED
Postmenopausal Osteoporosis
Radius Health, Inc.
 2019-04-09 PHASE1
NCT01657162 COMPLETED
Postmenopausal Osteoporosis
Radius Health, Inc.
 2012-11-20 PHASE3
NCT01343004 COMPLETED
Osteoporosis; Postmenopausal Osteoporosis
Radius Health, Inc.
 2011-04 PHASE3
NCT01674621 COMPLETED
Post Menopausal Osteoporosis
Radius Health, Inc.
 2012-09-25 PHASE2
NCT00542425 COMPLETED
Osteoporosis
Radius Health, Inc.
 2007-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-01)

Check the Abaloparatide (BA058) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Abaloparatide functions as a potent and selective agonist of the parathyroid hormone receptor 1 signaling pathway, activating downstream G protein-coupled signaling cascades to stimulate osteoblast proliferation and anabolic bone matrix synthesis. This selective activation promotes osteoblastic bone formation over resorption, thereby increasing bone mineral density and supporting fracture healing in clinical conditions such as postmenopausal osteoporosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.