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. 2023 May 17;8:202. doi: 10.1038/s41392-023-01467-8

Table 4.

Recent clinical trials targeting bone remodeling to treat bone diseases

Individual Agent Target Type Source Enrollment Sponsor Phase Status
Osteoporosis
Postmenopausal osteoporosis Denosumab RANKL Monoclonal antibody NCT00089791 7808 Amgen Phase III Completed
Glucocorticoid-induced Osteoporosis NCT03164928 24 Amgen Phase III Active, not recruiting
Osteoporosis associated to systemic mastocytosis NCT03401060 24 Assistance Publique - Hôpitaux de Paris Phase III Active, not recruiting
Postmenopausal osteoporosis Romosozumab (versus Alendronate Sclerostin NCT01588509 60 Amgen Phase I Completed
Chinese postmenopausal osteoporosis Romosozumab NCT05067335 564 UCB Biopharma SRL Phase III Active, not recruiting
Glucocorticoid-induced Osteoporosis Romosozumab (versus Denosumab) NCT04091243 72 Tuen Mun Hospital Phase IV Active, not recruiting
Women with low bone mineral density Blosozumab (LY2541546) NCT01144377 154 Eli Lilly and Company Phase II Completed
Postmenopausal osteoporosis SHR-1222 NCT04435158 107 Jiangsu HengRui Medicine Co., Ltd. Phase I Active, not recruiting
MK-0822 Cathepsin K Small-molecule inhibitor NCT00529373 16071 Merck Sharp & Dohme LLC Phase III Completed
Teriparatide PTH1R Recombinant polypeptide NCT01709110 1366 Eli Lilly and Company Phase IV Completed
Lactobacillus Reuteri Gut-bone axis Probiotics NCT04169789 239 Sahlgrenska University Hospital, Sweden Not applicable Completed
Lactobacillus Acidophilus NCT05332626 60 Poznan University of Life Sciences Enrolling by invitation
Motor-complete spinal cord injury-induced osteoporosis Rosuvastatin Calcium Hepatic hydroxymethyl-glutaryl coenzyme A Small-molecule inhibitor NCT03113994 8 Dr. B. Catharine. Craven Phase II Active, not recruiting
Simvastatin NCT02946424 20 Craig Hospital Phase II Active, not recruiting
Postmenopausal osteoporosis Atorvastatin NCT02342015 20 University of Padova Phase IV Completed
MK-0429 α5β3 NCT00533650 227 Merck Sharp & Dohme LLC Phase II Completed
Osteoporosis Fucosylated BMSCs Bone marrow Cell NCT02566655 10 Red de Terapia Celular Phase I Completed
Osteopenia secondary to glucocorticoids LLP2A-Ale MSC PDB NCT03197623 58 Nancy E. Lane, MD Phase I Completed
Postmenopausal osteoporosis Quercetin Senescent cell Natural senolytic NCT05371340 33 Kennesaw State University Not applicable Completed
Healthy elderly women Dasatinib, Quercetin, Fisetin Senolytics NCT04313634 120 Sundeep Khosla, M.D. Phase II Recruiting
Osteoarthritis (OA)
Patients scheduled for total knee replacement LNA043 Integrin α5β1 Small-molecule drug NCT02491281 28 Novartis Pharmaceuticals Phase I Completed
Knee OA NCT04864392 550 Phase II Recruiting
MIV-711 Cathepsin K NCT03037489 50 Medivir Phase II Completed
NCT02705625 244
TGF-β/SMAD signaling pathway level NCT05218122 340 Dongzhimen Hospital, Beijing Observational trial Recruiting
Tanezumab NGF Monoclonal antibody NCT00830063 832 Pfizer Phase III Completed
Quercetin with/without Fisetin Senescent cell Natural senolytic NCT05276895 60 Assiut University Not applicable Not yet recruiting
Fisetin NCT05482672 120 Cale Jacobs, PhD Phase II/ III Not yet recruiting
NCT04210986 75 Steadman Philippon Research Institute Phase I/II Active, not recruiting
OA of interphalangeal finger joints Denosumab RANKL Monoclonal antibody NCT02771860 100 University Hospital, Ghent Phase II Completed
OA of the hip or knee TPX-100 Subchondral matrix Small peptide NCT02528188 3021 OrthoTrophix, Inc Phase II Completed
NCT02837900 14 Phase II Completed
Rheumatoid arthritis (RA)
RA Denosumab RANKL Monoclonal antibody NCT01973569 679 Daiichi Sankyo, Inc. Phase III Completed
NCT00095498 227 Amgen Phase II Completed
Juvenile idiopathic arthritis Sema4A level NCT05534347 300 Assistance Publique - Hôpitaux de Paris Observational trial Not yet recruiting
Osteogenesis Imperfecta (OI)
OI Romosozumab Sclerostin Monoclonal antibody NCT04545554 25 Amgen Phase I Active, not recruiting
Type I, III or IV OI Setrusumab (BPS804) NCT03118570 112 Ultragenyx Pharmaceutical Inc Phase II Completed
OI NCT05125809 219 Ultragenyx Pharmaceutical Inc Phase II/III Recruiting
Fresolimumab TGF-β NCT03064074 11 Baylor College of Medicine Phase I Completed
Adult OI SAR439459 NCT05231668 24 Sanofi Phase I Recruiting
OI Bone marrow-derived mesenchymal stromal cells N.A. Cell NCT05559801 12 Emory University Phase I/II Not yet recruiting
Bone marrow-derived mesenchymal stromal cells NCT03706482 18 Karolinska Institutet Phase I/II Active, not recruiting
Nontraumatic osteonecrosis
Osteonecrosis of femoral head Zoledronic Acid Osteoclast BP NCT00939900 110 Seoul National University Bundang Hospital Phase III Completed
Nontraumatic osteonecrosis RAB001 MSC PDB CTR20222771 n.a. RabPharma Phase I Not yet recruiting
Nontraumatic osteonecrosis of the knee Ibandronate Osteoclast BP NCT00532220 30 University Hospital, Basel, Switzerland Phase III Completed
Osteosarcoma
Recurrent or refractory osteosarcoma Denosumab RANKL Monoclonal antibody NCT02470091 56 Children’s Oncology Group Phase II Active, not recruiting
Recurrent, refractory, or progressive pulmonary metastatic osteosarcoma Natalizumab α4-integrin NCT03811886 20 Case Comprehensive Cancer Center Phase I/II Recruiting
Osteosarcoma ALMB-0168 Connexin 43 NCT04886765 238 AlaMab Therapeutics (Shanghai) Inc. Phase I/II Not yet recruiting
Recurrent, relapsed, or refractory solid tumors including osteosarcoma Pepinemab Sema 4D NCT03320330 26 Children’s Oncology Group Phase I/II Active, not recruiting
Osteosarcoma Chemotherapy (with or without zoledronic acid) Osteoclast BP NCT00470223 318 UNICANCER Phase III Active, not recruiting
Bone metastasis
Hormone refractory prostate cancer Denosumab RANKL Monoclonal antibody NCT00286091 1435 Amgen Phase III Completed
Unresectable or metastatic melanoma Denosumab in combination with immune checkpoint inhibitors NCT03161756 72 Melanoma and Skin Cancer Trials Limited Phase I/II Active, not recruiting
Lung cancer with bone metastases Denosumab with Nivolumab NCT03669523 82 Centre Hospitalier Annecy Genevois Phase II Active, not recruiting
Paget’s Disease of Bone
Pathophysiology of Paget’s Disease of Bone N.A. N.A. N.A. NCT02802384 11 Johns Hopkins University Observational trial Active, not recruiting

BP bisphosphonate, PDC peptide-drug conjugate, MSC mesenchymal stem cell, NGF nerve growth factor, Sema semaphorin, TGF-β transforming growth factor-β