| brazikumab (AMG 139) / AstraZeneca |
| Terminated | 3 | 18 | Europe, US, RoW | Brazikumab Induction Dose, Brazikumab Maintenance Dose | AstraZeneca | Crohn's Disease, IBD | 09/23 | 09/23 | | |
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| Terminated | 2/3 | 89 | Europe, Canada, US, RoW | Brazikumab low dose, Brazikumab high dose, Humira®, Placebo | AstraZeneca | Crohn's Disease, IBD | 10/23 | 10/23 | | |
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Expedition, NCT04718818: An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis |
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| Recruiting | 2 | 225 | Europe, Canada, US, RoW | Brazikumab, Vedolizumab, Placebo | AstraZeneca | Ulcerative Colitis | 07/22 | 09/23 | | |
| Terminated | 2 | 57 | Europe, Japan, US, RoW | Brazikumab Maintenance Dose, Brazikumab Induction Dose | AstraZeneca | Ulcerative Colitis | 10/23 | 10/23 | | |
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| Terminated | 2 | 242 | Europe, Canada, Japan, US, RoW | Brazikumab, Placebo | AstraZeneca | Ulcerative Colitis, IBD | 10/23 | 10/23 | | |
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| Prolia (denosumab) / Amgen |
ACTRN12621000728831: Open-Label Study to Evaluate the Inter-subject Variability of Single Dose Prolia Pharmacokinetics and Pharmacodynamics, Administered by Subcutaneous Injection in Healthy Postmenopausal Women |
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| Not yet recruiting | 4 | 20 | | | Christchurch Clinical Studies Trust, Christchurch Clinical Studies Trust | Osteoporosis | | | | |
ChiCTR2000037044: Multicenter clinical study on standardized diagnosis and treatment of thyroid cancer spinal metastasis |
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| Recruiting | 4 | 80 | | PD-1 monoclonal antibody combined with zoledronic acid and denosumab ;PD-1 monoclonal antibody combined with zoledronic acid | Affiliated Sixth People's Hospital, Shanghai Jiaotong University; Shanghai Jiao Tong University Affiliated Sixth People's Hospital, funding | Thyroid cancer bone metastasis | | | | |
NCT02156960: Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients |
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| Recruiting | 4 | 100 | Japan | Denosumab treatment in osteoporotic patients, Teriparatide treatment in osteoporotic patients, Denosumab and teriparatide treatment in osteoporotic patients | Shinshu University | Osteoporosis | 05/15 | 11/22 | | |
2012-003574-66: Bone anchored femoral amputation prostheses - Denusomab Trial |
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| Ongoing | 4 | 14 | Europe | Prolia, Prolia | Ortopædkirurgisk Forskning - Aarhus Universitetshospita, Aarhus Universitet, Karen Elise Jensens Fond | leg amputee | | | | |
2016-000852-91: Study to investigate changes in BMD of the lumbar spine (LS) one year after treatment discontinuation in denosumab-treated women and in denosumab-treated women who received a single infusion of zoledronic acid after treatment discontinuation. |
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| Ongoing | 4 | 80 | Europe | Solution for infusion, Aclasta | Leiden University Medical Center, Leiden University Medical Center | Treatment of patients with with postmenopausal osteoporosis, Diseases of bones that leads to an increased risk of fracture, Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
NCT03811509: Breast Cancer Women on Aromatase Inhibitors Treatment |
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| Recruiting | 4 | 1000 | Europe | bisphosphonate, denosumab | Parc de Salut Mar, Instituto de Salud Carlos III | Osteoporosis, Osteoporosis Fracture, Arthralgia Generalized | 01/21 | 12/22 | | |
2016-001925-15: Effects of a treatment with Denosumab, applied together with either Nivolumab oder Pembrolizumab, in patients with skin cancer and bone metastases Effekte einer Behandlung mit Denosumab in Kombination mit etnweder Nivolumab oder Pembrolizumab auf Patienten mit Hautkrebs und Knochenmetastasen |
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| Not yet recruiting | 4 | 20 | Europe | DENOSUMAB, OPDIVO, KEYTRUDA, YERVOY, Solution for injection, Concentrate for solution for infusion, Powder for concentrate for solution for infusion, XGEVA | Alcedis GmbH, Amgen GmbH | Metastatic malignant melanoma Metastasiertes malignes Melanom, Skin cancer with bone metastases Hautkrebs mit Knochenmetastatsen, Diseases [C] - Skin and Connective Tissue Diseases [C17] | | | | |
| Recruiting | 4 | 80 | | Denosumab ;Placebo | The First Affiliated Hospital (Shenzhen People's Hospital), Southern University of Science and Technology; Shenzhen People's Hospital, Basic Research Key Project of Shenzhen Science and Technology Innovation Commission | Lumber disease | | | | |
NCT03029442: The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury |
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| Terminated | 4 | 5 | US | Denosumab (Prolia), Xgeva, Placebo (normal saline) | James J. Peters Veterans Affairs Medical Center, Kessler Institute for Rehabilitation | Secondary Osteoporosis, Spinal Cord Injury | 12/21 | 10/22 | | |
| Recruiting | 4 | 80 | | denosumab ;placebo | The First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital); Shenzhen People's Hospital, Basic research key project of Shenzhen Science and Technology Innovation Commission | Degenerate meniscus lesions | | | | |
2020-004903-15: DMAB Discontinuation and Switching Study Discontinuazione e switch del denosumab |
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| Not yet recruiting | 4 | 50 | Europe | Alendronato, Acido Zoledronico, Denosumab, [Alendronato], [042337016], [Denosumab], Tablet, Infusion, Solution for injection in pre-filled syringe | University of Alabama at Birmingham, Amgen | Glucocorticoid-Induced Osteoporosis (GIOP) Osteoporosi indotta da glucocorticoidi (GIOP), Osteoporosis Osteoporosi, Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
NCT04467983: Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone |
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| Recruiting | 4 | 70 | US | Denosumab Injection, Prolia, Abaloparatide, Tymlos | Hospital for Special Surgery, New York, Radius Health, Inc., Crozer-Keystone Health System | Osteoporosis, Postmenopausal | 04/26 | 06/26 | | |
NCT05203588: Effects of Denosumab on Bone Fusion in Osteoporotic Patients After Lumbar Fusion |
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| Recruiting | 4 | 116 | RoW | Denosumab 60 mg/ml Injectable Solution [Prolia], calcium and vitamin D | Shanghai Changzheng Hospital | Osteoporosis, Fusion of Spine, Lumbar Region | 10/22 | 10/23 | | |
ChiCTR2100051404: Denosumab and vertebral kyphoplasty for osteoporotic vertebral compression fractures |
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| Not yet recruiting | 4 | 80 | | Denosumab ;Placebo | The First Affiliated Hospital, Southern University of Science and Technology (Shenzhen People's Hospital); Shenzhen People's Hospital, Basic Research Key Project of Shenzhen Science and Technology Innovation Commission | osteoporotic vertebral compression fractures | | | | |
| Not yet recruiting | 4 | 80 | | denosumab ;placebo | The First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital); Shenzhen People's Hospital, Basic research key project of Shenzhen Science and Technology Innovation Commission | lumber disease | | | | |
| Not yet recruiting | 4 | 80 | | denosumab ;placebo | The First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital); Shenzhen People's Hospital, Basic research key project of Shenzhen Science and Technology Innovation Commission | Cervical spondylosis | | | | |
ChiCTR2100051422: Denosumab effect on bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial |
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| Not yet recruiting | 4 | 80 | | denosumab ;placebo | Shenzhen People's Hospital; Shenzhen People's Hospital, Basic research key project of Shenzhen Science and Technology Innovation Commission | osteoporotic vertebral compression fractures | | | | |
ChiCTR2100051424: Internal screw fixation of dissulzumab vs zoledronic acid and osteoporotic vertebral compression fractures |
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| Not yet recruiting | 4 | 80 | | denosumab+placebo ;denosumab placebo+zoledronic acid | Shenzhen People's Hospital; Shenzhen People's Hospital, Basic research key project of Shenzhen Science and Technology Innovation Commission | osteoporotic vertebral compression fractures | | | | |
| Completed | 4 | 101 | RoW | Zoledronic Acid, Aclasta, Denosumab, Prolia | National Taiwan University Hospital | Osteoporosis | 07/23 | 12/23 | | |
NCT03623633: Comparative Antiresorptive Efficacy Discontinuation of Denosumab |
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| Active, not recruiting | 4 | 51 | US | denosumab, Prolia, alendronate, Fosamax, raloxifene, Evista | Massachusetts General Hospital | Osteoporosis, Postmenopausal, Osteoporosis | 02/23 | 08/23 | | |
| Enrolling by invitation | 4 | 40 | Europe | Denosumab 60 MG/ML Prefilled Syringe [Prolia], Xgeva, Zoledronic Acid, Aclasta | University Medical Centre Ljubljana | Primary Hyperparathyroidism, Osteoporosis | 05/23 | 05/23 | | |
2022-002611-29: DEnosumab for the treatment of FIbrous Dysplasia/McCune-Albright Syndrome in adults (DeFiD) Denosumab voor de behandeling van Fibreuze Dysplasie/McCune-Albright syndroom in volwassenen (de DeFiD studie) |
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| Not yet recruiting | 4 | 82 | Europe | Injection, Denosumab (Xgeva), Natrium Chloride 0.9% | Leiden University Medical Center, Leiden University Medical Center | Fibrous Dysplasia/ McCune Albright Syndrome Fibreuze Dysplasie/McCune Albright Syndroom, Fibrous Dysplasia/McCune-Albright syndrome (FD/MAS) is a rare disease, consisting of the replacement of normal bone tissue with fibrous tissue. Fibreuze dysplasie is een zeldzame genetische aandoening ve, waarbijgezond bot wordt vervangen door fibreus weefsel., Diseases [C] - Hormonal diseases [C19] | | | | |
| Completed | 4 | 85 | Europe, US, RoW | Denosumab, AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand | Amgen | Giant Cell Tumor of Bone | 07/23 | 07/23 | | |
| Completed | 4 | 201 | US | denosumab, Prolia, Placebo, Calcium and Vitamin D | Susan L. Greenspan, National Institutes of Health (NIH), National Institute on Aging (NIA) | Osteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures | 08/23 | 08/23 | | |
NCT04091243: Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users |
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| Completed | 4 | 70 | RoW | Romosozumab | Tuen Mun Hospital | Glucocorticoid-induced Osteoporosis | 10/23 | 11/23 | | |
ChiCTR2200066227: Clinical and imaging studies of denosumab on fracture healing of distal radius in postmenopausal women |
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| Not yet recruiting | 4 | 50 | | RANKL monoclonal antibodies + VitD3 + calcium carbonate ;VitD3 + calcium carbonate | Renji Hospital, Shanghai Jiaotong University School of Medicine; Renji Hospital, Shanghai Jiaotong University School of Medicine, China Medical Education Association | Osteoporosis | | | | |
NCT05559268: Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty |
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| Not yet recruiting | 4 | 60 | NA | Denosumab 60 MG/ML Injectable Solution [Prolia], Placebo | The Affiliated Hospital of Qingdao University | Osteoarthritis, Knee | 12/23 | 12/23 | | |
| Active, not recruiting | 4 | 45 | US | DMAB Discontinuation and Switching | University of Alabama at Birmingham, Maastricht University, Vrije Universiteit Brussel, Amgen | Osteoporosis | 08/25 | 08/25 | | |
NCT06272227: Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients |
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| Not yet recruiting | 4 | 340 | RoW | alfacalcidol, placebo, Denosumab | Yonsei University | Sarcopenia | 09/25 | 09/25 | | |
ChiCTR2200056463: Efficacy and safety of desomumab in the treatment of chronic kidney disease-mineral and bone disorder complicated with low bone mineral density |
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| Not yet recruiting | 4 | 60 | | Denosumab 60mg subcutaneously | Tianjin Hospital; Tianjin Hospital, Health Science and Technology Project of Tianjin | chronic kidney disease-mineral and bone disorder | | | | |
NCT06643780: RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis |
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| Recruiting | 4 | 120 | RoW | Denosumab, Zolendronic Acid | Prince of Wales Hospital, Shatin, Hong Kong, Chinese University of Hong Kong | Sarcopenia in Elderly | 04/27 | 10/27 | | |
NCT05010590: Anabolic Therapy in Postmenopausal Osteoporosis |
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| Active, not recruiting | 4 | 50 | US | Romosozumab, Denosumab | Massachusetts General Hospital | Postmenopausal Osteoporosis | 05/25 | 05/25 | | |
NCT04087096: Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery |
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| Active, not recruiting | 4 | 36 | US | Denosumab, Prolia, Placebo, Zoledronic Acid, Reclast | Massachusetts General Hospital, University of California, San Francisco, San Francisco VA Health Care System | Bariatric Surgery Candidate, Bone Loss | 08/24 | 08/24 | | |
NCT06332014: Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China |
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| Recruiting | 4 | 100 | RoW | Prolia, Denosumab | Amgen | Osteoporosis | 08/26 | 08/26 | | |
NCT06472050: Romosozumab Versus Denosumab in GIOP: a 2-year Extension Study |
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| Recruiting | 4 | 63 | RoW | Romosozumab, Evenity (brand names), Denosumab, Prolia (brand name) | Tuen Mun Hospital | Osteoporosis, Glucocorticoids Toxicity | 12/25 | 03/26 | | |
ChiCTR2200063438: A multicenter clinical study on the efficacy and safety of Denosumab in the treatment of myeloma bone disease |
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| Not yet recruiting | 4 | 120 | | Denosumab ;Zoledronic acid ;Denosumab | Tianjin Medical University General Hospital; Blood Diseases Hospital and Institute of Hematology, PUMC, Tianjin Medical University General Hospital | Multiple Myeloma | | | | |
NCT05630768: Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women |
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| Active, not recruiting | 4 | 155 | RoW | Risedronate Sodium 35 MG [Actonel], Calcium Vitamin D combination | Dong-A ST Co., Ltd. | Postmenopausal Osteoporosis | 07/25 | 07/25 | | |
REaCT-HOLD BMA, NCT04549207: Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer |
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| Active, not recruiting | 4 | 240 | Canada | Bone modifying agent, Zoledronate, Denosumab, Pamidronate | Ottawa Hospital Research Institute | Breast Cancer, Castration-resistant Prostate Cancer | 06/25 | 06/26 | | |
| Recruiting | 4 | 70 | Europe | Denosumab, Prolia, Alendronate Sodium, Fosamax | Aristotle University Of Thessaloniki, 424 General Military Hospital | Nonalcoholic Fatty Liver, Osteoporosis, Postmenopausal | 09/25 | 09/26 | | |
DeFiD, NCT05966064: DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults |
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| Recruiting | 4 | 82 | Europe | Denosumab 120 Mg/1.7 Ml Inj, Xgeva, Placebo | Natasha Appelman-Dijkstra | Fibrous Dysplasia, McCune Albright Syndrome | 12/27 | 12/28 | | |
NCT05884372: Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis. |
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| Recruiting | 4 | 100 | RoW | Eldecalcitol, Native Vitamin D, Denosumab, Calcium | Xi'an Honghui Hospital, Chugai Pharma China Co., Ltd. | Osteoporosis in Postmenopausal Women | 12/24 | 06/25 | | |
MORD, NCT06720350: Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures |
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| Not yet recruiting | 4 | 60 | RoW | Romosozumab and Denosumab Combination Therapy, Romosozumab Prefilled Syringe [Evenity], Denosumab (Prolia) | Marmara University | Osteoporosis in Post-menopausal Women | 10/26 | 12/26 | | |
| Recruiting | 4 | 200 | Europe | Zoledronate, Placebo | Aarhus University Hospital | Osteoporosis, Postmenopausal | 02/25 | 02/27 | | |
NCT05180032: Treatment With Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI |
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| Recruiting | 4 | 39 | US | Romoszumab, Evenity, Denosumab, Prolia, Placebo | James J. Peters Veterans Affairs Medical Center, Kessler Institute for Rehabilitation | Osteoporosis, Spinal Cord Injuries | 03/25 | 03/27 | | |
SAFEST, NCT06767150: StrAtegies for Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal OSTeoporosis |
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| Not yet recruiting | 4 | 200 | Europe | a second infusion of ZOL when crosslaps levels reach 300 pg/mL, a rescue second infusion at month-12 (standard traitment) | University Hospital, Toulouse | Postmenopausal Osteoporosis | 03/30 | 03/30 | | |
ChiCTR2300070789: Effect of Denosumab on Glucose Metabolism in Postmenopausal Osteoporotic Women with Prediabetes: A Study Protocol for a 12-month Multicenter, Randomized, Open-label, Controlled Trial |
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| Not yet recruiting | 4 | 212 | | Denosumab ;Alendronate | Chinese PLA General Hospital; Chinese People’s Liberation Army General Hospital, the Excellent Young Scholars Training Program (2020-YQPY-001)；Young Elite Scientist Sponsorship Program (BYESS2022); National Natural Science Foundation of China (81972102). | prediabetes；osteoporosis | | | | |
NCT06588153: A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China |
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| Not yet recruiting | 4 | 100 | NA | Prolia®, Denosumab | Amgen | Glucocorticoid-induced Osteoporosis | 05/27 | 05/27 | | |
ChiCTR2000031557: Comparison of efficacy and safety of denosumab versus zoledronic acid in adjuvant therapy in patients with bone metastasis: a multi-center randomized controlled trial |
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| Not yet recruiting | 4 | 200 | | zoledronic acid ;denosumab | Shanghai Changzheng Hospital; Shanghai Changzheng Hospital, Grants for Scientific Research | Bone metastasis | | | | |
| Active, not recruiting | 4 | 20 | US | Denosumab, Zoledronic Acid, Denosumab Placebo, Zoledronic Acid Placebo | Nami Safai Haeri, The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA) | Sarcopenia, Osteoporosis | 07/25 | 07/26 | | |
NCT05101018: Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI |
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| Active, not recruiting | 4 | 40 | US | Romosozumab, Evenity, Denosumab, Prolia | James J. Peters Veterans Affairs Medical Center, Kessler Institute for Rehabilitation | Osteoporosis, Spinal Cord Injuries | 11/25 | 11/27 | | |
| Active, not recruiting | 4 | 60 | Canada | Denosumab 60 mg/ml, Prolia, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate | Western University, Canada, ICES, Academic Medical Organization of Southwestern Ontario, Western University, The Kidney Foundation of Canada | Kidney Diseases, Dialysis; Complications, Fragility Fracture, Chronic Kidney Disease-Mineral and Bone Disorder | 12/25 | 12/25 | | |
NCT05091099: The Optimal Sequential Therapy After Long Term Denosumab Treatment |
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| Recruiting | 4 | 44 | RoW | Alendronate, Zoledronic acid | National Taiwan University Hospital | Osteoporosis | 12/25 | 12/25 | | |
ChiCTR2200066151: A study to evaluate the efficacy and safety of denosumab versus zoledronic acid in the treatment of osteopenia or osteoporosis in early breast cancer patients with aromatase inhibitors |
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| Not yet recruiting | 4 | 480 | | Denosumab 60mg SC / 6 months ;Zoledronic acid 5mg IV / 12months | The First Hospital of China Medical University; The First Hospital of China Medical University, Self-financing | Osteoporosis | | | | |
ChiCTR2300071406: Effect of continuous denosumab on PFS of multiple myeloma patients: a prospective multicenter observational study |
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| Recruiting | 4 | 163 | | None | Beijing Jishuitan Hospital; Beijing Jishuitan Hospital, None | Multiple myeloma | | | | |
ChiCTR2300067942: Prospective Precision Intervention Study for Osteoporotic Fractures Based on Risk Stratification |
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| Not yet recruiting | 4 | 15000 | | Active health/bone health basic supplements (calcium and vitamin D)/TCM treatment ;Oral alendronate therapy/oral risephosphate therapy/denosumab therapy/intravenous bisphosphonate therapy ;Teriparatide sequential oral alendronate sodium treatment/teriparatide sequential oral risephosphate sodium treatment/teriparatide sequential oral denosumab treatment/teriparatide sequential intravenous bisphosphonate treatment | The Second XiangYa Hospital, Central South University; The Second XiangYa Hospital, Central South University, National Key Research and Development Program (No.2021YFC2501705) | Osteoporotic fractures | | | | |
ChiCTR2300076108: Effect of desomumab combined with Teriparatide on interbody fusion rates after single-level lumbar fusion in postmenopausal osteoporosis: a prospective cohort study |
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| Recruiting | 4 | 72 | | Denosumab 60 mg subcutaneously every 6 months; Supplement with calcium and vitamin D; Teriparatide 20 ug subcutaneously daily the 1st day after surgery to 12 months after surgery; Supplement with calcium and vitamin D; Teriparatide 20 ug subcutaneously daily the 1st day after surgery to 12 months after surgery; Supplement with calcium and vitamin DDenosumab 60 mg subcutaneously every 6 months with Teriparatide 20 ug subcutaneously daily the 1st day after surgery to 12 months after surgery; Supplement with calcium and vitamin D; Calcium 600 mg/day and vitamin D 2000 IU/day | Dujiangyan People's Hospital; Dujiangyan People's Hospital, Chengdu Municipal Health Commission | spondylolisthesis or lumbar instability patients with primary osteoporosis | | | | |
| Not yet recruiting | 4 | 30 | | Initially Denosumab 60-120mg, every 3 months, subcutaneous injection, adjust following regimen based on serum ALP levels | Shanghai sixth people's hospital; Shanghai sixth people's hospital, horizontal project | Fibrous dysplasia of bone | | | | |
NCT05091086: The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy |
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| Recruiting | 4 | 60 | RoW | Denosumab, Zoledronic acid | National Taiwan University Hospital | Osteoporosis, Bone Mineral Density | 12/26 | 12/30 | | |
ChiCTR2400085597: A Phase 4, Single Arm, Open Label Study for the Efficacy and Safety of Prolia in Treatment of Male Subjects With Osteoporosis in Mainland China |
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| Not yet recruiting | 4 | 100 | | Prolia | The Sixth People‘s Hospital of Shanghai; Amgen Biotechnology Consulting (Shanghai) Co., Ltd, Amgen Biotechnology Consulting (Shanghai) Co., Ltd | Male osteoporosis | | | | |
NCT06118905: Preserving Geriatric Muscle With an Osteoporosis Medication |
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| Recruiting | 4 | 248 | US | Denosumab 60 MG/ML, Prolia, Zoledronic Acid 5Mg/Bag 100Ml Infusion, Reclast | Susan L. Greenspan | Osteoporosis | 04/27 | 04/28 | | |
ChiCTR2400082544: A multicenter, prospective, observational real-world study evaluating the efficacy and safety of Denosumab Injection in the treatment of postmenopausal osteoporotic fractures |
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| Not yet recruiting | 4 | 1000 | | | The First Affiliated Hospital of Suzhou University; The First Affiliated Hospital of Suzhou University, Provided by Marvelway (Shanghai) Biotech Co., LTD | fragility fracture | | | | |
ChiCTR2400090526: Effectiveness and Safety of Denosumab (Lukexin) in Patients with Rheumatoid Arthritis Who Have Achieved Disease Activity Target and Postmenopausal Osteoporosis: A 1-Year Follow-Up, Multicenter, Prospective, Real-World Study |
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| Recruiting | 4 | 200 | | None; None | Peking University First Hospital; Peking University First Hospital, Qilu Pharmaceutical Co., Ltd. | Rheumatoid Arthritis with Achieved Disease Activity Target and Postmenopausal Osteoporosis | | | | |
| Recruiting | 4 | 100 | US | Denosumab | University of Texas Southwestern Medical Center | Cystic Fibrosis | 07/27 | 07/27 | | |
ChiCTR2400090385: A Randomized Controlled Study on Different Frequencies of Denosumab Treatment in Patients with Bone Metastases from Advanced Non-Small Cell Lung Cancer (NSCLC) |
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| Not yet recruiting | 4 | 220 | | Denosumab 120 mg, subcutaneous injection, once every 6 weeks.; Denosumab 120 mg, subcutaneous injection, once every 4 weeks. | Affiliated Hospital of Guangdong Medical University; Affiliated Hospital of Guangdong Medical University, none | Patients with Bone Metastases from Advanced Non-Small Cell Lung Cancer (NSCLC) | | | | |
NCT04586660: Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone |
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| Recruiting | 4 | 35 | RoW | XGEVA®, Denosumab | Amgen | Giant Cell Tumor of Bone | 05/28 | 05/28 | | |
20190036, ChiCTR2400079411: A two-stage, prospective observational study describing the use and effectiveness of XGEVA/ANJIAWEI for the prevention of skeletal related events in patients with bone metastases from solid tumors rel |
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| Not yet recruiting | 4 | 1000 | | XGEVA/ANJIAWE; ZOMETA | Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center, Amgen Inc. | Patients with bone metastases from solid tumors (breast, prostate or lung cancer) | | | | |
ChiCTR2400088032: Efficacy and safety evaluation of denosumab in maintenance hemodialysis patients witn osteoporosis:a randomized controlled, multicenter, optimal efficacy study |
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| Not yet recruiting | 4 | 294 | | denosumab injection 60mg, injected subcutaneously every six months; coutinue with the original therapeutic schedule | The Third Affiliated Hospital of Southern Medical University; The Third Affiliated Hospital of Southern Medical University, Mabwell(Shanghai)Bioscience Co., Ltd. | maintenance hemodialysis patients witn osteoporosis | | | | |
2018-000552-18: Denosumab in the prevention of immobilization-induced bone loss in Intensive Care Unit patients Denosumab in der Vorbeugung des immobilisations-bedignten Knochenabbaus intensivpflichtiger Patienten |
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| Ongoing | 3 | 66 | Europe | Denosumab, Solution for injection, Prolia | Medical University of Vienna, Medical University of Vienna | Immobilization because of aneurysmal subarachnoidal haemorrhage (aSAH) with moderate-severe neurological deficits (e.g. hemiparesis) and reduced state of consciousness – equivalent to Hunt&Hess 4-5 – at the time of admission to ICU Immobilisation aufgrund einer aneurysmatischen Subarachnoidalblutung mit moderaten bis schweren neurologischen Defiziten (z.B.Hemiparese) aud reduziertem Bewusstsein – äquivalent Hunt&Hess 4-5 – zum Zeitpunkt der Aufnahme auf die Intensivstation, Immobilization because of reduced consciousness and neurological deficits because of an intracranial bleeding Immobilisation aufgrund von Bewusstseineintrübung und neurologischen Ausfällen bedingt durch eine Hirnblutung, Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
ACTRN12616001051437: A randomised, double-blind, placebo controlled trial to examine the effects of total oestradiol depletion on bone microstructure and the efficacy of denosumab in preventing microstructural bone decay in premenopausal women with early breast cancer
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| Completed | 3 | 114 | | | Professor Mathis Grossmann , University of Melbourne | premenopausal osteoporosis , breast cancer | | | | |
2018-003724-36: Efficacy of treatment with DENOsumab of an acute CHARCOT foot in patients with diabetes. |
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| Not yet recruiting | 3 | 38 | Europe | Solution for injection in pre-filled syringe, Prolia | Ole Lander Svendsen, Amgen Limited, Region Hovedstaden, GCP enhederne, Danske Regioner | acute Charcot foot (Charcot arthropathy; ICD-10: DM14.6) in patients with diabetes, Acute Charcot foot is a rare complication to diabetes, which is presenting as a red, swollen foot with increased skin temperature, that is followed by fractures of bones deformity of the foot., Diseases [C] - Hormonal diseases [C19] | | | | |
NCT04550949: To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors |
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| Recruiting | 3 | 700 | RoW | QL1206, recombinant human anti-RANKL monoclonal antibody injection, Xgeva, Denosumab Injection | Qilu Pharmaceutical Co., Ltd. | Bone Metastases | 03/21 | 06/22 | | |
2020-005974-91: Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis. |
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| Not yet recruiting | 3 | 440 | Europe | Prolia, CT-P41, Solution for injection in pre-filled syringe, Prolia | Celltrion, Inc, Celltrion, Inc | Osteoporosis is a systemic skeletal disease that is characterized by low bone mass and micro architectural deterioration of bone tissue, with a low bone mineral density (BMD) and consequent increase in bone fragility and susceptibility to fracture. The incidence of fractures varies greatly by country, but on average up to 50% of women > 50 years of age are at risk of fractures. Postmenopausal osteoporosis, resulting from estrogen deficiency, is the most common type of osteoporosis., Osteoporosis is defined as a systemic skeletal disorder characterized by low bone mass and micro architectural deterioration of bone tissue., Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
NCT04812509: Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors |
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| Completed | 3 | 708 | RoW | MW032, recombinant human anti-RANKL monoclonal antibody injection, Xgeva, Denosumab Injection | Mabwell (Shanghai) Bioscience Co., Ltd. | Bone Metastases | 04/21 | 01/22 | | |
2020-005343-23: Study of the antiresorptive treatment with alendronate versus no treatment after denosumab and aromatase inhibitors discontinuation in low fracture risk osteopenic postmenopausal women with non metastatic hormonal receptor positive breast cancer. Studio del trattamento anti-riassorbimento con alendronato rispetto a nessun trattamento dopo l’interruzione della terapia con denosumab e inibitori dell’aromatasi in donne a basso rischio di frattura osteopeniche in post-menopausa affette da carcinoma mammario non metastatico positivo al recettore ormonale. |
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| Not yet recruiting | 3 | 190 | Europe | Acido Alendronico, [Binosto], Effervescent tablet, BINOSTO - 70 MG COMPRESSE EFFERVESCENTI | IRCCS ISTITUTO ORTOPEDICO GALEAZZI S.P.A, Amgen, Abiogen Pharma S.p.A. | post-menopausal osteoporosis in women with non-metastatic hormonal receptor positive (HR+) breast cancer. osteoporosi post-menopausale in donne affette da carcinoma mammario non metastatico positivo per il recettore ormonale (HR+)., post-menopausal osteoporosis in women with non-metastatic hormonal receptor positive (HR+) breast cancer. osteoporosi post-menopausale in donne affette da carcinoma mammario non metastatico positivo per il recettore ormonale (HR+), Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
| Completed | 3 | 24 | Europe, Canada, US, RoW | Denosumab, Placebo | Amgen | Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With, Glucocorticoid-induced Osteoporosis | 12/21 | 12/23 | | |
2021-004811-26: A Phase 3 Study to Compare Enzene Denosumab (ENZ215) and Prolia®in Postmenopausal Women with Osteoporosis |
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| Ongoing | 3 | 504 | Europe | Enzene Denosumab (ENZ215), EU licensed Prolia®, ENZ215, Solution for injection in pre-filled syringe, Prolia | Alkem Laboratories Limited, Enzene BioSciences Ltd., | Postmenopausal osteoporosis, Osteoporosis in women after menopause, Body processes [G] - Bones and nerves physological processes [G11] | | | | |
2021-006545-36: Clinical trial to compare the efficacy, distribution within the body, safety and immune response between Bmab 1000 and Prolia in Postmenopausal Women with Osteoporosis Kliiniline uuring, et võrrelda Bmab 1000 ja Prolia efektiivsust, jaotumist organismis, ohutust ja immuunvastust osteoporoosiga menopausis naistel |
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| Not yet recruiting | 3 | 480 | Europe | Prolia, Bmab 1000, Solution for injection in pre-filled syringe, Prolia | Biocon Biologics UK Limited, Biocon Biologics UK Limited | Postmenopausal women diagnosed with osteoporosis, Postmenopausal women diagnosed with osteoporosis, Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
2021-005071-40: A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women with Osteoporosis, ALVOBOND Randomizované, dvojitě zaslepené, multicentrické klinické hodnocení sparalelním uspořádáním, opakovanými dávkami a dvěma rameny,porovnávající účinnost, bezpečnost, imunogenicitu a farmakokineticképrofily přípravku AVT03 a přípravku Prolia® (USA) u postmenopauzálníchžen s osteoporózou, ALVOBOND |
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| Not yet recruiting | 3 | 532 | RoW | denosumab, Prolia, AVT03, Solution for injection in pre-filled syringe, Prolia | Alvotech Swiss AG, Alvotech Swiss AG | Osteoporosis, Osteoporosis, Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
2022-002188-31: A randomized, double-blind, international multicenter, parallel-controlled phase III clinical study to compare the efficacy, safety, tolerability and immunogenicity of HLX14 vs. Denosumab Injection (Prolia®) in postmenopausal women with osteoporosis at high risk of fracture |
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| Not yet recruiting | 3 | 478 | Europe | Recombinant Anti-RANKL Human Monoclonal Antibody, Prolia, HLX14, Solution for injection, Prolia | Shanghai Henlius Biotech, Inc., Shanghai Henlius Biotech, Inc. | Osteoporosis at High Risk of Fracture, Osteoporosis at High Risk of Fracture, Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
NCT04729621: A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis |
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| Completed | 3 | 332 | Europe, US, RoW | TVB-009, Prolia® | Teva Pharmaceuticals USA, Teva Branded Pharmaceutical Products R&D, Inc. | Osteoporosis, Postmenopausal | 12/22 | 06/23 | | |
NCT04859569: Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors |
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| Recruiting | 3 | 850 | RoW | LY01011, recombinant anti-RANKL human monoclonal antibody injection, Xgeva®, Denosumab | Luye Pharma Group Ltd. | Bone Metastases From Solid Tumors | 12/22 | 06/23 | | |
| Recruiting | 3 | 100 | RoW | Denosumab 60 mg/ml [Prolia], Denosumab 6 month/subcutaneous, Zoledronate, Zoledronic acid | Shenzhen People's Hospital | Osteopenia, Lumbar Spondylolisthesis | 02/23 | 02/23 | | |
| Completed | 3 | 479 | Europe, RoW | CT-P41, US-licensed Prolia | Celltrion, Celltrion, Inc | Postmenopausal Women With Osteoporosis | 05/23 | 11/23 | | |
2022-002312-23: Comparative efficacy, safety, pharmacokinetic, and immunogenicity study of LY06006 and EU-Prolia in postmenopausal women with osteoporosis |
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| Not yet recruiting | 3 | 524 | Europe | LY06006, proposed denosumab biosimilar, EU sourced Prolia®, LY06006, Solution for injection in pre-filled syringe, Prolia | Shandong Boan Biotechnology Co., Ltd., Shandong Boan Biotechnology Co., Ltd. | Postmenopausal osteoporosis, Osteoporosis in women after menopause, Body processes [G] - Bones and nerves physological processes [G11] | | | | |
2020-005548-48: A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis |
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| Not yet recruiting | 3 | 326 | Europe | TVB-009 (denosumab) solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) (TVB-009P), PROLIA United States (US) (denosumab) solution for injection 60 mg/mL (1 mL) PFS, Solution for injection in pre-filled syringe | Teva Branded Pharmaceutical Products R&D, Inc., Teva Branded Pharmaceutical Products R&D, Inc. | Postmenopausal Osteoporosis, Postmenopausal Bone thinning, Diseases [C] - Musculoskeletal Diseases [C05] | | | | |
| Completed | 3 | 553 | Europe, RoW | FKS518, US-licensed Prolia | Fresenius Kabi SwissBioSim GmbH | Postmenopausal Osteoporosis | 08/23 | 08/23 | | |
NCT04591275: Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® . |
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| Recruiting | 3 | 278 | RoW | CMAB807 Injection, Denosumab Injection, Prolia® | Shanghai Biomabs Pharmaceutical Co., Ltd. | Postmenopausal Osteoporosis | 10/24 | 11/24 | | |
| Completed | 3 | 24 | Europe | Denosumab, XGeva®, Placebo | Assistance Publique - Hôpitaux de Paris, CEREMAST | Osteoporosis, Systemic Mastocytosis | 03/24 | 03/24 | | |
SIMBA, NCT05338086 / 2021-003609-24: A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis ( Study) |
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| Completed | 3 | 528 | Europe, RoW | MB09 (denosumab biosimilar), EU-Prolia, Elemental Calcium, Vitamin D | mAbxience Research S.L. | Postmenopausal Women With Osteoporosis | 12/23 | 05/24 | | |
| Completed | 3 | 473 | Europe, US, RoW | RGB-14-P, Prolia® | Gedeon Richter Plc. | Postmenopausal Osteoporosis | 10/23 | 11/23 | | |
NCT03324932: Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer |
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| Active, not recruiting | 3 | 160 | Japan | Denosumab Injection, pralia | Kyoto Prefectural University of Medicine | Breast Cancer | 12/23 | 12/27 | | |
NCT05405725: A Phase 3 Study to Compare Biosimilar Denosumab With Prolia® |
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| Recruiting | 3 | 504 | RoW | ENZ215, Prolia | Enzene Biosciences Ltd., Alkem Laboratories Ltd | Postmenopausal Osteoporosis | 02/24 | 08/24 | | |
NCT06154707: Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes |
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| Recruiting | 3 | 86 | RoW | Denosumab Injection, Normal saline injection (1.0ml/ branch) | Wuhan Union Hospital, China | Sarcopenia, Osteoporosis, Denosumab | 12/24 | 03/25 | | |
NCT06314698: Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease |
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| Not yet recruiting | 3 | 478 | NA | Narlumosbart, Narlumosbart Injection, JMT103, Denosumab, XGEVA®, AMG 162 | RenJi Hospital, Shanghai JMT-Bio Inc. | Multiple Myeloma, Bone Diseases | 12/24 | 04/27 | | |
NCT05352516 / 2022-002188-31: A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture |
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| Completed | 3 | 514 | RoW | HLX14, Prolia® | Shanghai Henlius Biotech, Shanghai Henlius Biotech, Inc. | Postmenopausal | 12/23 | 07/24 | | |
