Reliance Life Sciences Private Limited · TNFSF11 · Monoclonal Antibodies
denosumab is a monoclonal antibodies developed by Reliance Life Sciences Private Limited. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.
| Brand Names | RTPR045, RTPR 045, DenosteRel |
| Company | Reliance Life Sciences Private Limited |
| Drug Class | Monoclonal Antibodies, Antibody |
| Molecular Target | TNFSF11 |
| Route | Injectable (Others), Subcutaneous Injection |
| Status | Approved |
denosumab acts on 1 molecular target:
| TNFSF11 | TNF superfamily member 11 (ODF, CD254) |
denosumab is developed for 2 unique indications across 2 therapeutic areas.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Bone cancer | ✓ Approved |
| Musculoskeletal and connective tissue disorders | Osteoporosis | ✓ Approved |
Bagchi Pareeksit Rajkumar PR, Baviskar Padmakar Sudhakar PS, Yennemadi Swathi S
Zhou Fengye F, Liu Ying Y, Liang Chunfang C, Yun Sufang S
To evaluate short-term changes in serum calcium and the occurrence of values below prespecified thresholds after denosumab treatment in institutional oncology and primary hyperparathyroidism (PHPT) cohorts, and to interpret these findings within the context of FAERS reporting patterns and published PHPT evidence. We retrospectively analysed denosumab-treated patients at the Affiliated Hospital of Inner Mongolia Medical University; the retrospective study was performed in the Department of Clinical Pharmacy (oncology cohort, 2024; PHPT cohort, 2022-April 2025). Total serum calcium was evaluated at baseline and around Days 3 and 7. A downstream FAERS reanalysis used the fixed 2014Q1-2023Q2 dataset, and published PHPT reports were re-extracted for actual follow-up and complications. In the oncology subgroup with baseline calcium > 2.55 mmol/L, mean paired calcium changed from 3.101 to 2.278 mmol/L at Day 3 (n = 12; p = 0.0002) and from 3.158 to 1.990 mmol/L at Day 7 (n = 11; p < 0.0001). In PHPT, the corresponding changes were 3.376 to 2.661 mmol/L at Day 3 (n = 9; p = 0.0038) and 3.351 to 2.289 mmol/L at Day 7 (n = 8; p = 0.0013). During Days 1-10, calcium < 2.10 mmol/L occurred in 57/102 oncology patients with non-low baseline calcium and 4/9 PHPT patients; values < 1.60 mmol/L occurred in 3/102 and 0/9, respectively. Among 1433 FAERS hypocalcaemia reports, 1186 (82.76%) had at least one serious-outcome code, most often hospitalisation/prolonged hospitalisation (769; 53.66%) or another medically important condition (725; 50.59%). Crude hypocalcaemia reporting proportions were higher for 120 mg than 60 mg, for male than female reports, and for tumour-related than osteoporosis indications; the youngest evaluable age strata also had higher proportions, but denominators were small, and the comparisons were unadjusted. In the analysed cohorts, denosumab was followed by short-term calcium reduction in patients with baseline hypercalcaemia and in the small PHPT cohort. Values below 2.10 mmol/L were common in early follow-up, whereas values below 1.60 mmol/L were uncommon, and clinical hypocalcaemia was not systematically adjudicated. FAERS hypocalcaemia reports often carried serious-outcome codes, mainly hospitalisation and other medically important conditions, without establishing incidence, causality or independent risk factors.
Huang Zhenfan Z, Zhang Yuyu Y, Wu Qiongyu Q, Meng Shaoda S
Accelerated bone loss is often observed in postmenopausal women with breast cancer receiving long-term aromatase inhibitor (AI) therapy; particularly, there is a growing need for targeted nutritional interventions. This multi-database bibliometric study evaluated 25 years of literature from 2000 to 2025 retrieved from the Web of Science Core Collection and Scopus. Following PRISMA guidelines, 768 publications were assessed using R-based analytical workflows to examine output trends, collaboration networks, thematic evolution, and citation impact. Annual scientific production expanded between 2005 and reached a peak in 2011, followed by a stable plateau of annual output through 2025. With strong institutional networks in North America and Europe, the United States was the productivity leader. A conceptual transition from isolated antiresorptive medications (bisphosphonates, denosumab) to an integrative bone microenvironment preservation strategy was suggested by keyword and thematic analyses. Keyword patterns suggested that Vitamin D and calcium are frequently integrated as universal baseline co-therapies, and topics including obesity, treatment-associated arthralgia, and survivorship exhibited high citation impact. Studies on AI-associated bone loss (AIBL) have moved beyond routine BMD measurement to the structured co-management of micronutrients and metabolism, which may in turn guide future breast cancer survivorship research.
Meszaros Szilvia S, Szili Balazs B, Szabo Boglarka B, Nemeth Zsuzsanna Z et al.
Teriparatide (TPTD) is an anabolic therapy for severe osteoporosis. Clinical trials have shown its efficacy in reducing vertebral and non-vertebral fractures, data on hip fracture prevention in real-world settings and the impact of sequential antiresorptive (AR) therapy remain limited. We conducted a retrospective cohort study using the Hungarian National Health Insurance Database, which covers the entire population (~9.7 million). Patients with osteoporosis who received TPTD between 2010 and 2023, with treatment initiated by January 1, 2022. Hip fractures were tracked from day 180 after TPTD initiation for up to five years. Adherence was assessed via medication possession ratio. Post-TPTD AR therapy (bisphosphonate or denosumab) and the timing of its initiation were evaluated as factors influencing hip fracture risk. Poisson regression models were applied, adjusting for demographics, prior fractures, and healthcare utilization. Among 8,893 eligible patients, 574 hip fractures occurred during follow-up. High adherence was associated with reduced hip fracture risk by 20% (p<0.05). The number of fractures prior to treatment was also associated with fracture risk, increasing it by 11% (p<0.05). Delayed AR initiation was closely related to a proportional increase in risk, which grew proportionally with the time elapsed between the two treatments. In a cohort of patients exhibiting high adherence, deferring AR treatment for over 90 days post-TPTD therapy was associated with an increase of 19% in hip fracture risk when subsequent treatment involved bisphosphonates, and a 31% increase when denosumab was utilized as the follow-up therapy. The efficacy of teriparatide treatment was associated with patient adherence and the number of prior fractures. Neglecting to initiate AR treatment following teriparatide therapy, or starting it late, was strongly linked to an increased risk of hip fractures. Our findings provide real-world data supporting timely initiation of AR therapy post-TPTD for sustained fracture prevention.
Jiang Li L, Li Jinmin J, Fan Yue Y, Ling Xiang X et al.
Malignant giant cell tumor of bone (MGCTB) refers to the presence of high-grade sarcomatous components within a giant cell tumor of bone (GCTB). MGCTB is classified into primary (PMGCTB) and secondary (SMGCTB) forms. It is extremely rare and often misdiagnosed as other sarcomas, especially when typical GCTB morphology is absent, leading to diagnostic pitfalls. In this study, we analyze 15 cases of MGCTB, reviewing clinical data, pathological features, immunohistochemistry, molecular characteristics, and follow-up outcomes. PMGCTB was found to be rarer than SMGCTB. Clinical symptoms predominantly include pain, mass detection, and restricted movement. MGCTB may lack GCTB components entirely, with malignant areas often presenting as high-grade sarcomas, though low-grade sarcomatous features can also be observed. Immunohistochemical markers such as H3.3G34W and H3G34W gene mutations exhibit high specificity and sensitivity for GCTB and MGCTB diagnosis. However, in cases with high dedifferentiation, few or absent mononuclear stromal cells may result in negative H3.3G34W expression and undetectable H3.3G34W gene mutations. The presence of high-grade sarcomatous morphology in a giant cell-rich tumor warrants thorough exclusion of PMGCTB. Additionally, misdiagnosis as SMGCTB can occur after denosumab treatment for GCTB. In conclusion, a comprehensive diagnostic approach combining patient age, tumor location, imaging, histology, immunohistochemistry, and molecular findings, with genetic testing when necessary, is essential for accurate diagnosis of GCTB and MGCTB. With a median follow-up of 12 months (range, 1-120 months), the 1-, 3-, and 5-year overall survival rates of the cohort were 76.9%, 76.9%, and 61.5%, respectively, and the median overall survival was not reached.
Serneels Jill J, Duriez Laurentin L, Mouroz Eloïse E, Lyssens Aurélie A et al.
To describe the clinical presentation, diagnosis, and management of hypocalcemia secondary to inadvertent administration of denosumab in a 4-month-old kitten. A 4-month-old neutered female domestic shorthair kitten was presented with acute weakness, tremors, third eyelid prolapse, and ataxia for several hours. Physical examination revealed lethargy, tachycardia, hypothermia, mild dehydration, and apparent nausea. Neurologic findings included tremors, cerebellar ataxia, bilateral mydriasis, and decreased bilateral direct and indirect pupillary reflexes. ECG confirmed sinus tachycardia. Blood work showed severe ionized hypocalcemia (0.74 mmol/L [2.96 mg/dL]; reference interval [RI]: 1.10-1.40 [4.40-5.60]), mild hypokalemia (3.38 mmol/L [3.38 mEq/L]; RI: 3.90-4.90 [3.90-4.90]), and moderate hyperglycemia (10.8 mmol/L [194 mg/dL]; RI: 3.6-6.2 [64.86-111.71]). The owner later disclosed an accidental subcutaneous injection to the kitten with denosumab 1 week earlier, strongly suggesting drug-induced hypocalcemia. Treatment with IV calcium gluconate 10% (0.5 mL/kg over 10 min twice) resolved signs and normalized iCa (1.20 mmol/L [4.8 mg/dL]). Isotonic crystalloids with potassium and maropitant were given for hydration, electrolyte correction, and nausea. Oral calcium (60 mg/kg, q 24 h) was started on Day 1; iCa remained normal (1.26 mmol/L [5.04 mg/dL]) at Day 2, and the kitten was discharged. At Day 11, iCa was 1.19 mmol/L [4.76 mg/dL], the dose was halved, and at Day 18, iCa remained normal (1.24 mmol/L [4.96 mg/dL]), allowing for discontinuation of therapy. This report describes hypocalcemia secondary to inadvertent administration of denosumab to a kitten. The clinical manifestations and diagnosis are described, along with the details of management that led to the kitten in this report making a full recovery.
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