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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

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

PubMedJournal of orthopaedic surgery (Hong Kong)2026-07-17

Real-world comparative effectiveness of denosumab versus zoledronic acid on bone mineral density changes in postmenopausal osteoporosis: An IPTW cohort study.

Li Qinglong Q, Shi Huagang H, Hou Wei W, Gu Tao T et al.

BackgroundTo compare the real-world effectiveness and safety of denosumab versus zoledronic acid in postmenopausal osteoporosis (PMO) and characterize baseline fracture risk profiles.MethodsThis retrospective cohort study included 250 PMO patients treated with denosumab (n = 148) or zoledronic acid (n = 102). Inverse probability of treatment weighting (IPTW) was applied to balance baseline covariates. The primary endpoint was 12-month change in lumbar spine bone mineral density (BMD). Fracture risk status was descriptively analyzed.ResultsThe cohort was predominantly high-risk (98.4%). IPTW achieved adequate covariate balance. At 12 months, denosumab showed greater increases in lumbar spine BMD than zoledronic acid (6.09% vs. 4.82%; difference 1.27%, 95% CI: 0.474-2.067; P = 0.002), with consistent findings at the hip. Most adverse events were comparable between groups; however, acute phase reaction occurred significantly less frequently with denosumab, while no differences were observed in hypocalcemia or renal events.ConclusionDenosumab was associated with greater BMD gains than zoledronic acid over 12 months, with broadly comparable safety in a real-world PMO population. These findings are limited to short-term BMD outcomes.

PubMedThe spine journal : official journal of the North American Spine Society2026-07-17

Clinical Implications of Denosumab Discontinuation for Spine Surgeons.

Jain Charu C, Drake Matthew T MT, Essig David D, Virk Sohrab S et al.

PubMedAdvanced genetics (Hoboken, N.J.)2026-07-17

Genetic Bone Diseases: A Scoping Review of Pathology, Symptoms, Diagnosis, Treatment, and New Horizons.

Jones Colin C, Jayasuriya Ambalangodage C AC

Genetic bone diseases are a rare group of afflictions suffered by the general population. However, their rarity should not diminish research efforts to help patients understand and treat their diseases. This review summarizes the pathology, symptoms, diagnosis, and treatment insight into six well-known genetic bone diseases. Only six bone diseases are included due to the relatively low prevalence of them as whole limiting our scope to ensure accurate information and attention is provided for each disease individually. A literature search of PubMed is conducted, including studies published within the past five years (January 2020-December 2025). Thirty-six studies met inclusion criteria, and no significant risk of bias is identified among the selected articles. Study findings are synthesized into disease overview, clinical and radiographic features, and diagnostic and treatment approaches. Actively developing or novel therapies relevant to each disease are also included. These treatments include: fresolimumab for osteogenesis imperfecta, small interfering ribonucleic acid (RNA) therapy for Osteopetrosis, denosumab for Paget's disease of bone, vosoritide/recifercept/infigratinib for achondroplasia, mesenchymal stem cell therapy for craniosynostosis, and combination losartan and atenolol therapy for Marfan syndrome. These treatments are generally more recently acknowledged in literature and are either actively undergoing research or require further research to determine their efficacy.

PubMedInternational journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics2026-07-17

Pregnancy- and lactation-associated osteoporosis: A position statement of the IAPM, IOF, ECTS, ESCEO, IMS, and EMAS.

Hadji Peyman P, Athanasiadis Apostolos A, Brandi Maria-Luisa ML, Chakhtoura Marlene M et al.

Pregnancy- and lactation-associated osteoporosis (PLO) is a syndrome characterized by fragility fractures (most commonly vertebral, often multiple) occurring in late pregnancy or the early postpartum period. This position statement summarizes the current knowledge of PLO, and the recommended procedure for assessment, diagnosis and treatment based on a review of published evidence. As PLO is a rare condition, controlled, comparative clinical studies are limited. Individual studies were reviewed, focusing on design, size, follow-up, evaluation of safety, and factors that impact PLO outcomes. Diagnosis of PLO should include a detailed clinical examination, a review of medical and treatment history, and laboratory tests to rule out secondary osteoporosis. Imaging techniques can be used to inform the appropriate treatment pathway, which will depend on whether the patient is antepartum or postpartum. Management of PLO and fractures includes calcium/vitamin D intake/supplementation, considering stopping breastfeeding, and analgesia, if necessary. Treatment with bone-specific agents should be evaluated on an individual basis to reduce subsequent fracture risk, noting that their use in PLO patients is off label. If pharmacological treatments are used, they must be given alongside effective contraceptive measures. Bisphosphonates can pass the placental barrier and are detectable in bone for years, so adverse effects on future pregnancies, although not yet reported, cannot be excluded. Preferred treatment options are teriparatide/abaloparatide or romosozumab. Second-choice treatments are denosumab followed by bisphosphonates or bisphosphonates alone. This position statement includes a pragmatic approach for identifying women with PLO and suggests developing an individualized treatment plan that might include pharmaceutical intervention.

PubMedOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2026-07-17

Dietary and supplemental calcium intake and bone changes during antiresorptive osteoporosis treatment in older women: a longitudinal observational study.

Papageorgiou Maria M, Gugler Yvan Y, Ferrari Serge S, Rizzoli René R et al.

Calcium supplements are often prescribed with osteoporosis medications without considering dietary adequacy. In calcium-replete older women, calcium supplements had little effect on the response to antiresorptives, whereas low protein intake blunted their benefits. Calcium supplementation may be unnecessary when intake is adequate, and nutrition should be optimized for osteoporosis treatment. Osteoporosis medications (OM) are commonly prescribed with calcium supplements (CaS) without considering dietary adequacy. We investigated whether calcium and protein intakes influence the effect of OM on total hip bone mineral density (BMD) and strength in calcium-replete women. Data from 586 women (median age 67 years) from the Geneva Retirees Cohort were analyzed: 101 on menopausal hormone therapy (MHT), 67 on antiresorptives (AR) (bisphosphonates, denosumab or raloxifene), and 418 without OM. Annual changes in total hip BMD, strength, and structure were assessed over a median 3.5 years using 2D/3D-DXA and finite element analysis. Calcium and protein intakes were assessed by food frequency questionnaire; CaS use was recorded at baseline and follow-up. Total calcium intake (diet + supplements) was 1503 mg/day; 71% women met recommendations (≥ 1200 mg/day), 51% used CaS, and 70% vitamin D. MHT or AR increased total hip BMD and strength versus no OM. Neither total calcium intake (above or below 1200 mg/day) nor CaS use significantly affected bone outcomes. However, in women with low calcium intake (< 800 mg/day), no difference in changes of BMD or bone strength was observed between women with and without OM in the absence of CaS. In women with protein intake < 0.8 g/kg/day, AR effects were blunted, with reduced improvements in trabecular BMD (P = 0.009) and total hip strength (P = 0.040). In calcium-replete older women, protein intake rather than CaS influences total hip bone changes with OM. These findings question routine CaS in women with adequate calcium intake and emphasize the importance of sufficient protein intake for optimal osteoporosis management. GERICO http://www.isrctn.com/ISRCTN11865958.

PubMedJAMA2026-07-16

Hip Fractures: A Review.

Johannesdottir Fjola F, Roberts Jimmie E JE, Kiel Douglas P DP, Tsai Joy N JN

More than 14.2 million people worldwide and 280 000 in the US experience a hip fracture each year. The median 1-year mortality rate after a hip fracture is 22% and approximately 42% to 71% of patients regain their prefracture level of basic activities of daily living within 6 months. Hip fractures are classified as intracapsular or extracapsular and most commonly occur after a fall. Intracapsular hip fractures include femoral neck (34%) and femoral head (rare). Extracapsular fractures consist of intertrochanteric (48%) and subtrochanteric fractures (5.8%). In the US, between 2008 and 2017, hip fractures were associated with 1-year mortality rates of 26.9% among men and 18.5% among women. Older age is a major risk factor for hip fracture, with a hazard ratio of 1.35 (95% CI, 1.25-1.47) per 5-year increase in age. Women have higher incidence of hip fractures than men due to accelerated bone loss after menopause and higher incidence of falls. Other risk factors for hip fractures include low bone mineral density (bone density of 1 SD or below that of healthy young adults measured by dual-energy x-ray absorptiometry), prior fracture, and factors contributing to falls, such as weak muscles, poor visual acuity, and smoking. Surgery for hip fracture typically consists of hip joint replacement or hip joint stabilization, using embedded hardware (open reduction and internal fixation). Patients with hip fracture benefit from physical therapy and fall reduction strategies, such as muscle-strengthening exercises and modifying medications associated with increased fall risk, such as antidepressants, and should be treated with antiresorptive medications, such as bisphosphonates (alendronate, zoledronic acid) or denosumab to prevent subsequent fracture. To prevent a hip fracture, patients with vertebral osteoporosis at the spine may require anabolic therapy, such as teriparatide, abaloparatide, or romosozumab, before starting an antiresorptive. Hip fractures may lead to mobility limitations; declines in physical, emotional, and social functioning; and reduced health-related quality of life. Hip fractures are common among older people and are associated with a 1-year mortality rate of 22% and with reduced mobility and quality of life. Surgical repair for hip fracture typically consists of joint replacement or open reduction and internal fixation. Hip fracture treatment also includes physical therapy, fall reduction strategies, and medications to protect against fracture, such as bisphosphonates; denosumab; or anabolic drugs, such as parathyroid hormone analogues or romosozumab.

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