Clinical Trials

Teriparatide Acetate has been evaluated across numerous clinical trials spanning Phase 1 to Phase 4 investigations. These studies explore diverse indications, including postmenopausal osteoporosis, stress fractures of the tibia or fibula, femur fractures, osteoarthritis of the knee, and hypoparathyroidism-related hypocalcemia. Trial sponsorships encompass major academic medical centers and health networks such as Assistance Publique - Hôpitaux de Paris, Eli Lilly and Company, and Odense University Hospital, with recruitment statuses ranging from completed protocols like NCT00005006 and NCT04921124 to active enrollment by invitation. Overall, clinical research continues to assess the osteoanabolic efficacy, safety, bioequivalence, and functional recovery outcomes of this recombinant parathyroid hormone analogue across varied metabolic and skeletal pathologies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06264609 ENROLLING_BY_INVITATION
Osteoporosis
Paul F Netzel
 2024-02-01 PHASE4
NCT06558188 RECRUITING
Osteoporosis, Postmenopausal; Osteoporosis
Massachusetts General Hospital
 2025-02-03 PHASE4
NCT06898060 NOT_YET_RECRUITING
Postmenopausal Women With Osteoporosis
Qilu Pharmaceutical Co., Ltd.
 2025-06 PHASE3
NCT05151484 ACTIVE_NOT_RECRUITING
Age-Related Osteoporosis
Madhumathi Rao
 2022-03-21 PHASE4
NCT06303284 NOT_YET_RECRUITING
Ankle Fractures
University of Calgary
 2025-01-01 PHASE1; PHASE2
NCT04589819 ENROLLING_BY_INVITATION
Stress Fracture of Tibia or Fibula
University of South Carolina
 2022-12-08 PHASE4
NCT05866029 RECRUITING
Osteoporotic Fractures
Peking Union Medical College Hospital
 2023-05-26
NCT04522622 RECRUITING
Adynamic Bone Disease; Chronic Kidney Diseases; Cardiac Disease; Chronic Kidney Disease-Mineral and Bone Disorder
Ditte Hansen
 2021-12-15 PHASE4
NCT03770338 ACTIVE_NOT_RECRUITING
Osteoporosis; Fusion of Spine, Lumbar Region
The University of Hong Kong
 2019-03-01
NCT07242612 COMPLETED
Osteoporosis; Osteoporosis, Postmenopausal
Khyber Medical University Peshawar
 2025-10-01
NCT06951776 NOT_YET_RECRUITING
Circadian Rhythm Disorders; Osteoporosis
Peking University Third Hospital
 2025-05-01
NCT03994172 COMPLETED
Male Osteoporosis
VA Office of Research and Development
 2019-07-01 PHASE4
NCT03735537 COMPLETED
Osteogenesis Imperfecta
University of Edinburgh
 2016-11-01 PHASE4
NCT06061354 UNKNOWN
Bone Regeneration
Universidad de Valparaiso
 2023-08-23 PHASE4
NCT04669782 TERMINATED
Bone Metabolism Disorder; Aging Disorder; Osteoporosis
University of Milano Bicocca
 2020-11-24
NCT07028320 COMPLETED
Postmenopausal Women With Osteoporosis
Shenzhen Salubris Pharmaceuticals Co., Ltd.
 2021-12-03 PHASE3
NCT04473989 UNKNOWN
Colles' Fracture
Peking University Third Hospital
 2021-06-01 PHASE2
NCT03702140 UNKNOWN
Osteoporosis
Shinshu University
 2018-10-09 PHASE2
NCT05018637 UNKNOWN
Vertebral Compression Fracture; Osteoporotic Fractures
Inbo Han
 2020-09-01 PHASE2
NCT03072147 COMPLETED
Knee Osteoarthritis; Cartilage Degeneration
Christopher Ritchlin
 2017-05-01 PHASE2
NCT03472846 COMPLETED
Postmenopausal Osteoporosis; Diabetes Type 2
Medical University of Vienna
 2017-03-01 PHASE4
NCT03133195 COMPLETED
Unstable Intertrochanteric Fracture; Pertrochanteric Fracture of Femur, Closed
King Chulalongkorn Memorial Hospital
 2017-05-17 PHASE3
NCT04196855 UNKNOWN
Stress Fracture; Parathyroid Hormone
University of East Anglia
 2019-12-23 PHASE3
NCT04026256 COMPLETED
Postmenopausal Osteoporosis
Massachusetts General Hospital
 2019-09-02 PHASE4
NCT04750460 COMPLETED
Secondary Hyperparathyroidism; Chronic Kidney Disease-Mineral and Bone Disorder; Dialysis; Hypocalcemia; Hypoparathyroidism
Saint Petersburg State University, Russia
 2021-03-01 PHASE3
NCT01896011 COMPLETED
Non Displaced Atypical Femoral Fractures
University Health Network, Toronto
 2013-07 PHASE3
NCT04921124 COMPLETED
Stress Fracture
Norfolk and Norwich University Hospitals NHS Foundation Trust
 2021-05-24 PHASE3
NCT02440581 COMPLETED
Kidney Failure, Chronic
Hartmut Malluche, MD
 2015-07-01
NCT02972424 COMPLETED
Osteoporotic Fractures
Hospital for Special Surgery, New York
 2017-05-01 PHASE2
NCT04747392 COMPLETED
Postmenopausal Osteoporosis
Shenzhen Salubris Pharmaceuticals Co., Ltd.
 2020-08-19 PHASE1
NCT01679080 TERMINATED
Osteogenesis Imperfecta
University of Aarhus
 2012-11 PHASE2
NCT03720886 UNKNOWN
Postmenopausal Osteoporosis
Shenzhen Salubris Pharmaceuticals Co., Ltd.
 2018-10-01 PHASE1; PHASE2
NCT02824718 COMPLETED
Autosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment
Assistance Publique - Hôpitaux de Paris
 2017-06-06 PHASE2
NCT02049866 COMPLETED
Adult Idiopathic Generalized Osteoporosis
Elizabeth Shane
 2014-11-19 PHASE2
NCT02176382 COMPLETED
Postmenopausal Osteoporosis
Massachusetts General Hospital
 2014-08 PHASE4
NCT02023411 COMPLETED
Diabetic Neuropathic Arthropathy
Post Graduate Institute of Medical Education and Research, Chandigarh
 2014-01 PHASE2
NCT02563353 COMPLETED
Osteoporosis
Odense University Hospital
 2015-11
NCT02130973 UNKNOWN
Osteoporosis
Health Research, Inc.
 2013-08 PHASE4
NCT02090244 COMPLETED
Spinal Stenosis
University Hospital, Linkoeping
 2012-08 PHASE4
NCT03002428 COMPLETED
Osteoporosis
Pfenex, Inc
 2016-12 PHASE3
NCT01440803 COMPLETED
Adult Idiopathic Generalized Osteoporosis
Elizabeth Shane
 2012-08-02 PHASE2
NCT02955056 UNKNOWN
Fracture, Ankle
Nottingham University Hospitals NHS Trust
 2016-10 PHASE4
NCT02571140 COMPLETED
Drug Safety and Bioavailability
Entera Bio Ltd.
 2013-10 PHASE1
NCT00926380 COMPLETED
Osteoporosis
Massachusetts General Hospital
 2009-06 PHASE2
NCT01705587 COMPLETED
Osteoporosis; Atypical Femoral Fracture
Susan L. Greenspan
 2012-12 PHASE4
NCT02195895 COMPLETED
Spinal Cord Injury; Bone Loss; Osteoporosis
Northwestern University
 2014-04 PHASE2
NCT01709110 COMPLETED
Postmenopausal Osteoporosis
Eli Lilly and Company
 2012-10 PHASE4
NCT02656810 COMPLETED
Osteoporosis
Pfenex, Inc
 2015-12 PHASE1
NCT01801397 UNKNOWN
Low Bone Mass in Anorexia Nervosa Patients
University of Zurich
 2014-03 PHASE3
NCT00759772 COMPLETED
Anorexia Nervosa; Osteoporosis
Massachusetts General Hospital
 2008-09 PHASE2
NCT00668941 UNKNOWN
Osteoporosis
Helen Hayes Hospital
 2005-09 PHASE2
NCT01292252 COMPLETED
Lumbar Spondylosis; Lumbar Spondylolisthesis; Adult Degenerative Lumbar Scoliosis
Shane Burch
 2011-08 PHASE4
NCT02091492 WITHDRAWN
Osteoporosis, Age-Related; Humeral Fractures
Medical University of Vienna
 2014-06 PHASE3
NCT01734824 SUSPENDED
Bone Marrow Oedema Syndrome; High Turnover Bone Disease; Quality of Life
Medical University of Vienna
 2012-05 PHASE4
NCT02025179 COMPLETED
Spinal Cord Injury; Bone Loss; Osteoporosis
Northwestern University
 2013-01 PHASE2
NCT00887354 COMPLETED
Osteoporosis
Eli Lilly and Company
 2009-04 PHASE4
NCT01293292 COMPLETED
Osteoporosis
Sheffield Teaching Hospitals NHS Foundation Trust
 2011-01 PHASE4
NCT01225055 COMPLETED
Spinal Cord Injury; Bone Loss; Osteoporosis
Thomas J. Schnitzer
 2010-10 PHASE2
NCT01400516 COMPLETED
Rheumatoid Arthritis
Brigham and Women's Hospital
 2011-08 PHASE4
NCT01796301 COMPLETED
Postmenopausal Osteoporosis
Amgen
 2013-01-31 PHASE3
NCT02156960 UNKNOWN
Osteoporosis
Shinshu University
 2014-05 PHASE4
NCT01279187 TERMINATED
Implant
University of Michigan
 2011-02 PHASE2
NCT02223416 COMPLETED
Healthy
Gedeon Richter Plc.
 PHASE1
NCT01309399 COMPLETED
Osteoporosis
Health Research, Inc.
 2010-08
NCT01945788 UNKNOWN
Postmenopausal Osteoporosis With Pathological Fracture
Bio Sidus SA
 2013-06 PHASE4
NCT01343004 COMPLETED
Osteoporosis; Postmenopausal Osteoporosis
Radius Health, Inc.
 2011-04 PHASE3
NCT01913834 UNKNOWN
Osteoporosis
Nottingham University Hospitals NHS Trust
 2013-09 PHASE1
NCT01753856 COMPLETED
Osteoporosis
Eli Lilly and Company
 2013-01 PHASE4
NCT01656629 TERMINATED
Low Bone Density
Johns Hopkins University
 2012-08
NCT01760798 UNKNOWN
Osteoporosis
Post Graduate Institute of Medical Education and Research, Chandigarh
 2012-01
NCT01173081 UNKNOWN
Fractures
Ohio Orthopedic Center of Excellence
 2010-07 PHASE4
NCT01750086 COMPLETED
Postmenopausal Osteoporosis
Massachusetts General Hospital
 2013-01 PHASE4
NCT01105832 COMPLETED
Humeral Fracture
University Hospital, Linkoeping
 2010-04 PHASE4
NCT01171690 TERMINATED
Hypoparathyroidism Post-surgical
Mayo Clinic
 2010-11 PHASE2
NCT01473589 COMPLETED
Femur Neck Fracture
Eli Lilly and Company
 2012-02 PHASE3
NCT01360424 COMPLETED
Osteoporosis
Helsinki University Central Hospital
 2011-05 PHASE4
NCT01473602 COMPLETED
Femur Neck Fracture
Eli Lilly and Company
 2012-01 PHASE3
NCT02202603 COMPLETED
Drug Safety
Entera Bio Ltd.
 2011-07 PHASE1
NCT01063504 COMPLETED
Osteoarthritis of the Knee
University Hospital, Linkoeping
 2010-02 PHASE2
NCT01153425 COMPLETED
Osteoporosis, Osteopenia
University of Pennsylvania
 2008-07 PHASE4
NCT01535027 COMPLETED
Osteoporosis
Medical University of Vienna
 2006-03 PHASE4
NCT01166958 COMPLETED
Osteoporosis
University of Wisconsin, Madison
 2010-09 PHASE4
NCT01604057 UNKNOWN
Osteoporosis; Osteopenia
Azelon Pharmaceuticals
 2011-11 PHASE2
NCT00594906 TERMINATED
Pelvic Fracture
University of Rochester
 2008-01
NCT00826228 COMPLETED
Osteoporosis; Bone Loss; Spinal Cord Injury
Thomas J. Schnitzer
 2009-06 PHASE4
NCT00697463 COMPLETED
Menopause; Fracture; Osteoporosis
Columbia University
 2008-08-20 PHASE2; PHASE3
NCT01430104 COMPLETED
Osteoporosis
Eli Lilly and Company
 2011-08 PHASE4
NCT01611571 COMPLETED
Osteoporosis
Columbia University
 2003-12 PHASE3
NCT01321723 COMPLETED
Postmenopausal Osteoporosis
Unigene Laboratories Inc.
 2011-02 PHASE2
NCT01011556 COMPLETED
Osteoporosis
Eli Lilly and Company
 2009-11 PHASE2
NCT01250145 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 2010-11 PHASE1
NCT00896532 COMPLETED
Low Bone Mineral Density; Postmenopausal Osteoporosis
Amgen
 2009-06-03 PHASE2
NCT00131469 COMPLETED
Osteogenesis Imperfecta
Oregon Health and Science University
 2005-06 PHASE4
NCT00927186 COMPLETED
Osteoporosis, Post-menopausal
Eli Lilly and Company
 2009-07 PHASE4
NCT00557310 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 2007-11 PHASE4
NCT00503399 COMPLETED
Osteoporosis
Eli Lilly and Company
 2007-07 PHASE3
NCT00623974 TERMINATED
Hypocalcemia
M.D. Anderson Cancer Center
 2008-05 PHASE2
NCT00393380 TERMINATED
Leukemia, Myeloid, Chronic; Anemia, Aplastic; Myelofibrosis; Lymphoma; Hodgkin Disease; Leukemia, Lymphocytic, Chronic; Leukemia, Myelocytic, Acute; Leukemia, Lymphocytic, Acute
The Emmes Company, LLC
 2006-09 PHASE2
NCT00259298 COMPLETED
Osteoporosis
Eli Lilly and Company
 2005-11 PHASE4
NCT00343252 COMPLETED
Osteoporosis, Postmenopausal; Back Pain; Spinal Fracture
Eli Lilly and Company
 2006-06 PHASE3
NCT00542425 COMPLETED
Osteoporosis
Radius Health, Inc.
 2007-04 PHASE2
NCT00624481 WITHDRAWN
Osteopenia; Osteoporosis
Nastech Pharmaceutical Company, Inc.
 2008-03 PHASE2
NCT00535860 COMPLETED
Osteoporosis
TransPharma Medical
 2008-04 PHASE2
NCT00439244 COMPLETED
Osteoporosis
Novartis
 2006-12 PHASE3
NCT00471237 TERMINATED
Osteoporosis
GlaxoSmithKline
 2007-05-14 PHASE2
NCT00433160 COMPLETED
Osteoporosis
Eli Lilly and Company
 2007-01 PHASE3
NCT00754442 COMPLETED
Secondary Hyperparathyroidism
University of Maryland, Baltimore
 2007-02
NCT00414973 COMPLETED
Osteoporosis
Eli Lilly and Company
 2006-12 PHASE3
NCT00577863 COMPLETED
Osteoporosis
Eli Lilly and Company
 2008-01 PHASE3
NCT00347737 WITHDRAWN
Osteoporosis
Leland Graves III, MD
 2006-06
NCT00489918 COMPLETED
Osteoporosis
Zosano Pharma Corporation
 2007-06 PHASE2
NCT00051558 COMPLETED
Osteoporosis
Eli Lilly and Company
 2002-11 PHASE3
NCT00065637 COMPLETED
Osteopenia; Osteoporosis
University of California, San Francisco
 2003-12 PHASE3
NCT02416271 COMPLETED
Osteoporosis
Eli Lilly and Company
 2001-04 PHASE4
NCT00005006 COMPLETED
Osteoporosis
Helen Hayes Hospital
 1987-09 PHASE2
NCT00670501 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 1996-08 PHASE3
NCT00446589 TERMINATED
Osteoporosis
Papageorgiou General Hospital
 2006-07 PHASE4
NCT00543023 COMPLETED
Osteoporosis, Post-Menopausal
Eli Lilly and Company
 2003-06 PHASE3
NCT00190944 COMPLETED
Colles' Fracture
Eli Lilly and Company
 2004-12 PHASE2
NCT00239629 COMPLETED
Postmenopausal Osteoporosis
Eli Lilly and Company
 2005-09 PHASE4
NCT00130403 COMPLETED
Osteoporosis, Postmenopausal
Sanofi
 2004-03 PHASE4
NCT00532545 COMPLETED
Osteoporosis, Post-Menopausal
Eli Lilly and Company
 2003-04 PHASE4
NCT00191425 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 2002-08 PHASE4
NCT00035256 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 2001-10 PHASE4
NCT00191867 COMPLETED
Osteoporosis
Eli Lilly and Company
 2005-02 PHASE2
NCT00532207 COMPLETED
Osteoporosis, Post-Menopausal
Eli Lilly and Company
 2003-11 PHASE3
NCT00542984 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 2003-08 PHASE3
NCT00543218 COMPLETED
Osteoporosis, Post-Menopausal
Eli Lilly and Company
 2002-12 PHASE3
NCT00191893 COMPLETED
Osteoporosis
Eli Lilly and Company
 2003-09 PHASE3
NCT00191802 COMPLETED
Osteoporosis
Eli Lilly and Company
 2003-09 PHASE3
NCT00079924 COMPLETED
Postmenopausal Osteoporosis
Eli Lilly and Company
 2004-11 PHASE4
NCT00191321 COMPLETED
Osteoporosis
Eli Lilly and Company
 2004-07 PHASE3
NCT00046137 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-04-01)

Check the Teriparatide Acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Teriparatide Acetate binds selectively to the parathyroid hormone receptor 1 (PTH1R), stimulating downstream adenylate cyclase activity and cyclic AMP-dependent intracellular signaling cascades. This activation promotes osteoblast differentiation and bone matrix deposition over osteoclast-mediated resorption, driving anabolic bone formation and increasing mineral density to effectively manage postmenopausal osteoporosis and accelerate fracture repair.

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.