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denosumab (RTPR045 / RTPR 045 / DenosteRel)

✓ Approved

Reliance Life Sciences Private Limited · TNFSF11 · 单克隆抗体

什么是 denosumab？

denosumab 是一种单克隆抗体，由Reliance Life Sciences Private Limited研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Subcutaneous Injection。

药物档案

商品名RTPR045, RTPR 045, DenosteRel
公司Reliance Life Sciences Private Limited
药物类别单克隆抗体, 抗体
分子靶点TNFSF11
给药途径Injectable (Others), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Reliance Life Sciences Private Limited

作用机制

分子靶点

denosumab 作用于 1 个分子靶点：

TNFSF11TNF superfamily member 11 (ODF, CD254)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

denosumab 针对 2 个适应症，涉及 2 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Bone cancer✓ Approved
Musculoskeletal and connective tissue disordersOsteoporosis✓ Approved

相关研究文献

PubMedJournal of endocrinological investigation2026-07-25

Chronic kidney disease: from mineral dysregulation to bone and cardiovascular disease.

Moustaki Melpomeni M, Paschou Stavroula A SA, Palioura Eleni E, Kassi Evanthia E et al.

Chronic kidney disease-mineral bone disorder (CKD-MBD) concerns more than 50% of patients with moderate/severe CKD, increasing their risk for fractures and cardiovascular events. To present its pathogenesis, clinical presentation and management. A Pubmed search for CKD-MBD until December 2025 was conducted using combinations of relevant terms. Total-body positive phosphate balance, increased levels of fibroblast-growth factor 23 (FGF-23) and sclerostin, and bone resistance to parathyroid hormone (PTH) are the earliest detected abnormalities, followed by calcitriol deficiency, secondary hyperparathyroidism, and bone minerals derangement. High bone turnover and adynamic bone disease stem from PTH excess and deficiency/resistance respectively, with the latter being prevalent in early CKD, peritoneal dialysis and post-kidney transplantation. Osteomalacia is rare, while mixed uremic osteodystrophy is rather common. Fracture risk assessment is based on fracture risk assessment tool, bone mineral density testing and vertebral morphometry, while bone biopsy remains the gold standard for renal osteodystrophy evaluation. Cardiovascular manifestations include vascular calcifications and left ventricular hypertrophy induced by mineral stress in the setting of disrupted buffering system, osteoblastic differentiation of vascular smooth cells and direct FGF-23 effects in myocardium. In severe secondary hyperparathyroidism, active vitamin D and analogues, calcimimetics, and, in refractory cases, parathyroidectomy effectively lower PTH. In mild/moderate CKD, the efficacy of all anti-osteoporotic agents is mainly proven in post-menopausal women without biochemical evidence of CKD-MBD. In dialysis patients, denosumab is the best-studied agent, while recent data highlight pronounced therapeutic benefit of romosozumab. Finally, teriparatide has demonstrated utility in treating adynamic bone disease. Fracture risk prevention in CKD-MBD should be prioritized. Dedicated research and validation of CKD-specific bone turnover markers may assist towards this direction.

PMID 42501286
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PubMedJournal of endocrinological investigation2026-07-24

Osteoprotegerin is strongly associated with calcium and magnesium in seminal fluid but not affected by denosumab.

Yahyavi Sam Kafai SK, Jorsal Mads Joon MJ, Wriedt Emil Brink EB, Jørgensen Niels N et al.

While the effect of the RANKL-inhibitor denosumab on serum minerals is well-documented, its impact on seminal fluid minerals is poorly understood. This study examines the correlation between the high levels of soluble-RANKL, osteoprotegerin (OPG), and minerals in seminal fluid and whether this can be influenced by denosumab. Two cohorts comprised this study: 100 young men from the general Danish population with no reported fertility issues, and 91 infertile men who were treated with a single dose of denosumab (60 mg), or placebo in a randomized controlled trial assessing the effect on semen quality. Each man underwent a physical examination and semen analysis, including analysis of soluble RANKL, OPG, calcium, magnesium, and phosphate in the seminal fluid. In both men from the general population and infertile men, seminal OPG concentrations were positively correlated with seminal calcium (rnormal=0.54 and rinfertile=0.81), seminal magnesium (rnormal=0.58 and rinfertile=0.75), and a weak negative correlation was seen with seminal phosphate (rnormal=-0.17 and rinfertile=-0.34) concentrations. Seminal soluble RANKL was not associated with seminal minerals. Following 60 mg denosumab treatment, no changes were observed after 160 days in seminal calcium (p = 0.42), magnesium (p = 0.55), or phosphate concentrations (p = 0.63). Changes in seminal OPG were moderately negatively correlated with changes in serum AMH (r=-0.32), LH (r=-0.30), and FSH (r=-0.31). A strong correlation between OPG and minerals in seminal fluids from both normal and infertile men suggests that the release of these factors by the prostate or seminal vesicle is regulated by the same factors, but cannot be modified by a short-term systemic RANKL inhibition with denosumab. ClinicalTrials.gov NCT03030196. Registered January 24, 2017.

PMID 42496818
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PubMedCase reports in oncology2026-07-24

A Rare and Life-Threatening Case of Giant Cell Tumor of Bone: Massive Posterior Rib Origin Causing Airway Obstruction.

Iijima Yuka Y, Asano Naofumi N, Watanabe Kota K, Suzuki Takahiro T et al.

Primary giant cell tumor of bone (GCTB) of the rib is rare. Herein, we report a rare case of posterior rib GCTB causing airway compression. A 35-year-old woman complained of back pain and dyspnea for 4 months. A bone tumor in the posterior fifth rib was suspected, and needle biopsy confirmed the diagnosis of GCTB. The tumor occupied the right thoracic cavity, compressing the main bronchus and extensively invading the vertebral body. Because complete resection was initially considered infeasible, an airway stent was placed, and denosumab therapy was initiated. However, dyspnea recurred; therefore, complete surgical resection was subsequently performed in two stages: intrathoracic and chest wall part. During the initial surgery, extracorporeal membrane oxygenation support was prepared because of the anticipated high-risk airway, and awake bronchoscopic intubation was performed with the patient in the sitting position. Postoperatively, denosumab therapy was continued, and no recurrence was observed during 60 months of follow-up. Posterior rib GCTB with airway compression is extremely rare and may be difficult to control with denosumab alone. In the present case, favorable long-term local control was achieved through a combination of surgical resection and denosumab therapy.

PMID 42494799
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PubMedTherapeutic advances in musculoskeletal disease2026-07-24

Longitudinal osteoporosis therapy: treat-to-target and sequential strategies-a narrative review.

Tskhakaia Irakli I, Danila Maria I MI

Osteoporosis is a chronic skeletal disorder in which reduced bone strength confers sustained fracture risk, often necessitating long-term pharmacotherapy with a multi-phase approach rather than a single "one and done" drug choice. Contemporary guidelines increasingly advocate a treat-to-target (TTT), goal-directed approach: clinicians define an explicit target, most often a total hip T-score threshold that corresponds to a lower fracture risk than baseline; select initial therapy according to baseline risk; and reassess and adjust treatment intensity until that target is achieved and maintained. Within this framework, sequential strategies are central. Anabolic-first sequences (e.g., abaloparatide or teriparatide followed by alendronate, or romosozumab followed by alendronate or denosumab) consistently produce larger and more durable gains in bone mineral density and fracture risk reduction in very-high-risk patients than antiresorptive monotherapy. Transitions from long-term bisphosphonates to teriparatide are complicated by transient increased remodeling and modest hip BMD responses, whereas switching to romosozumab yields more robust bone mineral density (BMD) gains at the hip. Notably, denosumab discontinuation demands structured bisphosphonate "exit" therapy to avoid rebound bone loss and multiple vertebral fractures. Across all pathways, rare but serious adverse events (e.g., atypical femoral fractures, medication-related osteonecrosis of the jaw, cardiovascular events), patient adherence and persistence, and insurance coverage constraints strongly shape the feasibility and desirability of specific regimens. This narrative review synthesizes mechanistic and clinical evidence underlying TTT osteoporosis care, summarizes the evidence base for sequential osteoporosis pharmacotherapy, and proposes practical strategies to help clinicians choose, transition, and discontinue therapies while preserving skeletal gains and minimizing harm over decades of longitudinal osteoporosis care.

PMID 42494964
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PubMedReports (MDPI)2026-07-24

Secondary Malignant Transformation of Giant Cell Tumor of Bone Nine Years After Initial Curettage: A Case Report and Literature Review.

Alshaygy Ibrahim S IS, Alanezi Mishari N MN, Aldosari Omar A OA, Alomar Safana M SM et al.

Background and Clinical Significance: Malignant transformation of giant cell tumor of bone (GCTB) is a rare but clinically significant event, most commonly associated with radiotherapy, denosumab therapy, or recurrent disease. Secondary malignant transformation occurring in the absence of recognized risk factors is exceptionally uncommon. We report a rare case of high-grade sarcomatous transformation of proximal humeral GCTB after a prolonged latency period without prior radiotherapy, denosumab exposure, or documented recurrence; Case Presentation: A 27-year-old female initially presented with right shoulder pain and was diagnosed with proximal humeral GCTB. She underwent intralesional curettage and bone grafting, with histopathological confirmation of benign GCTB. Nine years later, she developed progressive shoulder pain, functional limitation, and systemic symptoms. Imaging demonstrated an aggressive lytic lesion with cortical destruction and soft-tissue extension involving the proximal humerus. Repeat curettage and histopathological evaluation revealed high-grade spindle cell sarcoma consistent with malignant transformation of GCTB. The patient received neoadjuvant chemotherapy followed by wide resection and endoprosthetic reconstruction of the proximal humerus, with additional adjuvant chemotherapy postoperatively. At two-year follow-up, she remained disease-free with excellent functional recovery and satisfactory quality of life; Conclusions: This case highlights the potential for delayed malignant transformation of GCTB even in the absence of established predisposing factors. Clinicians should maintain long-term vigilance in patients treated for GCTB, particularly when new pain, functional decline, or aggressive radiologic features develop years after initial treatment. Early recognition and multidisciplinary management are essential to optimize oncologic and functional outcomes.

PMID 42496499
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PubMedFrontiers in endocrinology2026-07-24

Efficacy and safety of abaloparatide, denosumab, teriparatide, oral bisphosphonates, and intravenous bisphosphonates in the treatment of postmenopausal osteoporosis: a systematic review and Bayesian network meta-analysis.

Wang Yan Y, Wang Xiaoyan X, Yu Guihong G, Zhang Libao L et al.

Postmenopausal osteoporosis increases the risk of fractures, particularly in the lumbar spine, femoral neck, and total hip. Pharmacological interventions include anabolic agents (abaloparatide [ABA], teriparatide [TER]), antiresorptive agents (oral/intravenous bisphosphonates [OBP/IBP], denosumab [DEN]), and conventional therapy or placebo (PLA/CTRL). Evidence on their comparative efficacy and safety in postmenopausal women is limited. We conducted a Bayesian network meta-analysis of randomized controlled trials (RCTs) to evaluate the relative efficacy and safety of ABA, TER, OBP, IBP, DEN, and PLA/CTRL in postmenopausal women with osteoporosis. Primary outcomes included changes in lumbar spine, femoral neck, and total hip bone mineral density (BMD). Safety outcomes included all adverse events (AEs) and serious adverse events (SAEs). Data were synthesized using SUCRA rankings and network consistency was assessed via node-splitting and deviance information criteria (DIC). Twenty-three RCTs comprising 80-7, 808 postmenopausal women were included. ABA demonstrated the greatest improvement in lumbar spine and femoral neck BMD, followed by TER, while ABA showed the highest effect on total hip BMD. IBP and DEN provided moderate benefits, superior to PLA/CTRL. TER and OBP had the lowest risk for AEs, and ABA and PLA/CTRL showed the lowest risk for SAEs. Overall, anabolic agents significantly improved BMD at the spine and femoral neck, whereas antiresorptive agents were more effective for hip BMD. ABA and TER are most effective for improving spinal and femoral neck BMD in postmenopausal women, whereas ABA is superior for total hip BMD. Safety profiles were favorable for TER, OBP, and ABA. These findings provide evidence to guide individualized treatment selection based on fracture risk and high-risk skeletal sites in postmenopausal women.

PMID 42494861
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