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denosumab (RTPR045 / RTPR 045 / DenosteRel)

✓ Approved

Reliance Life Sciences Private Limited · TNFSF11 · Monoclonal Antibodies

What is denosumab?

denosumab is a monoclonal antibodies developed by Reliance Life Sciences Private Limited. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesRTPR045, RTPR 045, DenosteRel
CompanyReliance Life Sciences Private Limited
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetTNFSF11
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Reliance Life Sciences Private Limited

Mechanism of Action

Molecular Targets

denosumab acts on 1 molecular target:

TNFSF11TNF superfamily member 11 (ODF, CD254)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

denosumab is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Bone cancer✓ Approved
Musculoskeletal and connective tissue disordersOsteoporosis✓ Approved

Related Research Articles

PubMedSkeletal radiology2026-08-30

De novo osteosarcoma following prolonged denosumab treatment for giant cell tumor of bone at an anatomically distant site: a case report.

Burbank Katherine Elon KE, Henshaw Robert Mikael RM, Jelinek James Stephen JS, Murphey Mark D MD

Denosumab is a monoclonal antibody targeting RANKL, FDA-approved for the treatment of giant cell tumor of bone (GCTB). While it has shown efficacy in tumor regression and bone preservation, rare cases of malignant transformation to osteosarcoma have been associated with denosumab treatments. Previous literature has attributed such cases to either initial misdiagnosis of a malignant giant cell tumor at baseline presentation or, more rarely, transformation of previously histologically benign GCTB to a secondary malignant GCTB. To our knowledge, these cases involved or arose from an existing giant cell tumor neoplasm. We present a unique case of a patient who developed de novo osteosarcoma at a distant location from their original GCTB tumor following prolonged denosumab therapy, highlighting the clinical course, diagnostic challenges, and therapeutic considerations.

PMID 42668307
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PubMedJournal of bone oncology2026-08-28

Dissociated skeletal response to first-line immunotherapy in synchronous bone metastatic non-small cell lung cancer patients: Clinical profiles and survival benefit of denosumab adjunction.

Massy E E, Stacoffe N N, Fauvernier M M, Duruisseaux M M et al.

Patients with bone metastases (BM) from non-small cell lung cancer (NSCLC) derive less clinical benefit from immune checkpoint inhibitors (ICIs) than those without skeletal involvement. We aimed to characterize bone-specific disease control profiles under first-line ICI therapy and explore the association of denosumab with clinical outcomes. We conducted a multicenter retrospective study in BM-NSCLC patients, naïve to systemic therapy, treated with first-line ICI monotherapy, with or without denosumab. Radiological response in soft tissue and bone compartments was assessed at 6 months using iRECIST. Disease control (DCR: iCR, iPR, or iSD) and dissociated response (discordant DCR between compartments) were predefined. Denosumab impact was evaluated using logistic regression and Cox models. Sixty-one patients were included (16 women [26%]; mean age 65.8 ± 9.6 years). Soft tissue DCR was 64% and bone DCR was 62% at M6. Dissociated response occurred in 21% (n = 13), associated with female sex, KRAS mutations, and elevated C-reactive protein (all p < 0.05). Denosumab did not alter bone DCR (73% vs. 60%; adjusted OR 0.64; 95% CI: 0.12-2.99; p = 0.582) but was associated with improved progression-free survival (log-rank p = 0.06) and reduced hazard of progression or death (adjusted HR 0.28; 95% CI: 0.06-1.33; p = 0.110). ICI-driven immune activation does not translate uniformly across compartments. Female sex, KRAS mutation, and systemic inflammation are potential determinants of bone-specific resistance. While denosumab did not significantly modify bone DCR, its trend toward association with improved progression-free survival and reduced risk of progression or death generates the hypothesis of an immunomodulatory effect warranting prospective evaluation.

PMID 42662853
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PubMedFrontiers in aging2026-08-28

Age-related differences in BMD response during three years of denosumab treatment.

Ishikawa Koji K, Asada Tomoyuki T, Richardson William W, Marius Choiselle C et al.

Denosumab increases bone mineral density and reduces fracture risk in patients with osteoporosis. However, whether BMD response to denosumab differs by age, particularly during longer term treatment, remains unclear. This study investigated the association between baseline age and BMD gain during 3 years of denosumab treatment in patients with osteoporosis. This retrospective study included patients with osteoporosis who were treated with denosumab. DXA-based BMD and bone turnover markers were followed for up to 3 years. Percent BMD gain from baseline was evaluated. The longitudinal association between baseline age and %BMD gain was assessed using multivariable linear mixed effects models for the lumbar spine and total hip. Analyses were performed in the treatment naive cohort and the overall cohort according to prior osteoporosis treatment status. A total of 255 patients were included, of whom 110 were treatment naive. In multivariable linear mixed effects models, older baseline age was associated with smaller lumbar spine %BMD gain in the treatment naive cohort at both 1 and 3 years. Each 1 year increase in age was associated with a 0.187 percentage point lower lumbar spine %BMD gain at 1 year and a 0.293 percentage point lower gain at 3 years (1 year: β = -0.187, p = 0.006, 3 years: β = -0.293, p = 0.031). In contrast, baseline age was not significantly associated with total hip %BMD gain in the treatment naive cohort (1 year: β = -0.011, p = 0.826, 3 years: β = 0.028, p = 0.727). In the overall cohort, baseline age was not significantly associated with %BMD gain at either skeletal site. Older baseline age was associated with a modestly smaller lumbar spine BMD gain in treatment-naive patients, whereas no statistically significant age-related association was observed at the total hip. These findings indicate a modest, site-specific association between baseline age and BMD gain in treatment-naive patients.

PMID 42661953
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PubMedKlinicka onkologie : casopis Ceske a Slovenske onkologicke spolecnosti2026-08-28

Contribution of bone scintigraphy and PET/CT in the differential diagnosis of bone involvement in a patient with fibrous dysplasia and monoclonal gammopathy of undetermined significance and fibrous dysplasia treatment with denosumab.

Řehák Zdeněk Z, Ptáčník Václav V, Adam Zdeněk Z, Koukalová Renata R et al.

We describe a patient who has both fibrous dysplasia (FD) and monoclonal gammopathy of undetermined significance (MGUS). The simultaneous occurrence of these two pathological conditions is rare, and it is necessary to distinguish whether the bones are being affected by FD or multiple myeloma. The patient's problems began with a non-healing tooth extraction, raising suspicion of osteomyelitis. Later, he was also examined for fever of unknown origin, as he had elevated inflammatory markers, low-grade fever, and headaches. According to skeletal scintigraphy, the patient had a craniofacial skeleton affected by FD. Given the presence of IgG lambda type MGUS, it was necessary to rule out transformation of MGUS into multiple myeloma. PET/CT examination with the radiopharmaceuticals sodium fluoride (18F-NaF) and fluorodeoxyglucose (18F-FDG) was used to differentiate this. In the craniofacial skeleton area, the CT image corresponded to FD, and these lesions showed significant NaF accumulation. 18F-FDG accumulation was less pronounced, and none of the lesions with a high 18F-NaF uptake had an osteolytic character, which is indicative of skeletal involvement by FD rather than multiple myeloma. The patient was treated with denosumab, with an initial administration at 28-day intervals and a planned extension of the intervals to 3 months after stabilization of the condition. Immediately after the first denosumab injection, the headaches caused by craniofacial skeletal involvement due to FD disappeared. In the coexistence of MGUS and FD, it is necessary to precisely determine whether the bones are affected by FD or multiple myeloma by using PET/CT imaging and radiopharmaceuticals 18F-NaF and 18F-FDG. The text provides an overview of the drug treatment of FD from a 2026 perspective.

PMID 42663157
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PubMedCureus2026-08-28

Clival Aneurysmal Bone Cyst With Cavernous Sinus Extension: A Diagnostic Challenge.

Zimmermann Raphael R, Gomes Galvão da Trindade Érico Samuel ÉS, Borges Alves Lucas L, Escalante Encinas Williams W et al.

Aneurysmal bone cyst (ABC) is a benign but locally aggressive osseous neoplasm that predominantly affects children and young adults, with skull base involvement being uncommon. We report a 59-year-old woman with a progressively enlarging clival ABC extending into the sphenoid sinus and right cavernous sinus. She initially presented with right frontal headache and subsequently developed progressive diplopia, ptosis, ophthalmoplegia, and trigeminal sensory impairment. An initial endoscopic endonasal transsphenoidal biopsy was interpreted as a mucocele; however, continued clinical deterioration and radiological progression prompted repeat tissue sampling through a transcranial microsurgical approach. Histopathological and immunohistochemical findings, together with the detection of a USP6 gene rearrangement by fluorescence in situ hybridization, supported the diagnosis of primary ABC in the appropriate clinicopathological context. Complete surgical resection was not feasible because of extensive skull base and cavernous sinus involvement. The patient was referred to clinical oncology for consideration of denosumab; however, treatment was not recommended because the available supporting evidence was considered insufficient. The lesion continued to progress, with subsequent neurological deterioration, and the patient died approximately 10 months after the definitive diagnosis. This case illustrates the diagnostic challenges of ABC in an unusual anatomical location and age group and emphasizes the importance of clinicoradiological-pathological correlation, diagnostic reassessment when findings are discordant, and the appropriate use of ancillary molecular testing in selected cases.

PMID 42662863
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PubMedJournal of clinical medicine2026-08-27

Preventing Hip (Proximal Femoral) Fractures: An Evidence-Based Review for Clinicians.

Kawai Toshiyuki T, Okuzu Yaichiro Y, Takaoka Yusuke Y, Natsume Daichi D et al.

Hip fractures are among the most devastating fragility fractures, associated with excess mortality, disability, loss of independence, and substantial healthcare costs. Although age-standardized incidence has declined in several high-income countries, absolute case numbers continue to rise because of population aging. This review summarizes contemporary PubMed-indexed evidence on the epidemiology, risk stratification, and prevention of proximal femoral fractures, with emphasis on hip-fracture outcomes rather than vertebral or composite endpoints alone. We discuss secular trends, FRAX-based case findings and screening, non-pharmacologic strategies, pharmacologic therapy, and health-system interventions relevant to both primary and secondary prevention. Among non-pharmacologic measures, long-term balance-challenging and resistance-based exercise has the most consistent evidence for reducing falls and likely contributes to fracture prevention, whereas multifactorial interventions, home hazard modification, calcium/vitamin D supplementation, and hip protectors are best targeted to selected high-risk populations and care settings. Among medications, bisphosphonates, denosumab, and romosozumab-based sequential strategies show the strongest evidence for reducing hip-fracture risk, while teriparatide and abaloparatide have important roles in very-high-risk patients despite less direct hip-fracture evidence. Menopausal hormone therapy reduces hip fractures in younger postmenopausal women but is limited by extra-skeletal risk, and selective estrogen receptor modulators are primarily vertebral-fracture agents. A major message of this review is that effective prevention depends not only on drug efficacy but also on implementation. Fracture liaison services, orthogeriatric co-management, prompt treatment after fragility fracture, and sustained adherence support are essential to close persistent care gaps. Preventing hip fractures therefore requires an integrated, risk-stratified approach that combines skeletal protection, falls prevention, and reliable health-system delivery.

PMID 42652552
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