Table 4 Recent clinical trials targeting bone remodeling to treat bone diseases

From: Targeting strategies for bone diseases: signaling pathways and clinical studies

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	Gut-bone axis	Probiotics	NCT05332626	60	Poznan University of Life Sciences	Not applicable	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
Motor-complete spinal cord injury-induced osteoporosis	Simvastatin			NCT02946424	20	Craig Hospital	Phase II	Active, not recruiting
Postmenopausal osteoporosis	Atorvastatin			NCT02342015	20	University of Padova	Phase IV	Completed
Postmenopausal osteoporosis	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	Senescent cell	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	LNA043	Integrin α5β1		NCT04864392	550	Novartis Pharmaceuticals	Phase II	Recruiting
	MIV-711	Cathepsin K		NCT03037489	50	Medivir	Phase II	Completed
	MIV-711	Cathepsin K		NCT02705625	244	Medivir	Phase II	Completed
	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
	Fisetin			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
OA of the hip or knee	TPX-100	Subchondral matrix	Small peptide	NCT02837900	14	OrthoTrophix, Inc	Phase II	Completed
Rheumatoid arthritis (RA)
RA	Denosumab	RANKL	Monoclonal antibody	NCT01973569	679	Daiichi Sankyo, Inc.	Phase III	Completed
RA	Denosumab	RANKL	Monoclonal antibody	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	Setrusumab (BPS804)			NCT05125809	219	Ultragenyx Pharmaceutical Inc	Phase II/III	Recruiting
OI	Fresolimumab	TGF-β		NCT03064074	11	Baylor College of Medicine	Phase I	Completed
Adult OI	SAR439459	TGF-β		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
OI	Bone marrow-derived mesenchymal stromal cells	N.A.	Cell	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

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Table 4 Recent clinical trials targeting bone remodeling to treat bone diseases

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