target directory

denosumab clinical trial intelligence

Trials are included when the normalized target field matches this target directory. Full protocol, result, eligibility and IP analysis is available inside the premium workspace.

Validated reports

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target

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normalized field

NCT05402865

Source recordAI-normalized

A Real-world Study on Patients of Surgically Unsalvageable or Severe Post-surgery Morbidity Associated Giant Cell Tumor of Bone

This is a retrospective observational real-world study, which evaluates the efficacy and safety of denosumab and non-denosumab therapies in the treatment of Chinese populations of surgically unsalvageable or severe post-surgery morbidity associated giant cell tumor of bone (GCTB), collectively referred to as unresectable GCTB, during 2013-2021 in three medical centers, serving as the external control for a single arm phase Ib/II trial on JMT103 treatment of GCTB. 301 patients were enrolled and divided into 2 groups according to their actual previous exposures. Group 1 (n=135) was denosumab group. Group 2 (n=166) included two types of exposures other than denosumab: other anti-GCTB drug therapies, or no therapy on GCTB patients. The dosage, route, frequency and other administration methods was collected according to the actual previous treatment records. The primary outcome measure was the tumor response rate \[radiographic tumor response (CR/PR evaluated by ICDs or EORTC criteria) within 12 weeks, or at least 90% reduction of osteoclast like giant cells compared with baseline\]. The key secondary endpoint was the tumor response rate \[radiographic tumor response (CR/PR evaluated by ICDS or EORTC criteria), or at least 90% reduction of osteoclast like giant cells compared with baseline\]. Other secondary Outcome Measures include: proportion of patients whose tumors was surgically resectable; median duration of tumor response (DOR), disease control rate (DCR), and time to disease progression (TTP); and types and proportion of key adverse reactions.

AI analysis

Indication: Giant Cell Tumor of Bone

Modality: monoclonal antibody

Target: Denosumab

Sponsor: Shanghai JMT-Bio Inc.

Source URL: ClinicalTrials.gov

Source updated: Jun 02, 2022

Ingested: Jun 18, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by target_normalized: Denosumab

View original source fields

Condition raw: Giant Cell Tumor of Bone

Condition normalized: Giant Cell Tumor of Bone

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab

Target normalized: Denosumab

Open report

NCT05419050

Source recordAI-normalized

A Phase 2 Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia

Background: Fibrous dysplasia (FD) is a disease that affects the bones. It causes bone lesions that can become weak and lead to fractures, deformity, and nerve injuries. FD bone lesions begin to develop soon after birth and grow during childhood. The lesions stop growing in adults but can still cause disability. Researchers want to find ways to stop the growth of FD bone lesions. Objective: To test a study drug (denosumab) in children with FD. Eligibility: Children aged 4 to 14 years with FD and who are also enrolled in the Screening and Natural History protocol (98-D-0145). Design: Participants will have a screening visit at the NIH clinic or by telehealth. Their medical history will be reviewed. Participants will stay overnight in the hospital 4 times in 76 weeks. Each stay will last 5 to 7 nights. Participants will also visit a local lab for blood and urine tests every 4 weeks during the study. Participants will receive denosumab once every 4 weeks for 48 weeks. The medication is given as a shot injected under the skin using a small needle. Some injections may be performed at home by a caregiver. The caregiver will receive training for this procedure. Participants will undergo many tests that may be repeated throughout the study. They will have a dental exam. They will have tests of their strength and ability to move freely. They will have x-rays and other scans to get pictures of their bones. Participants will be given another medicine that is administered through a needle in the arm over 30 minutes.

AI analysis

Indication: Fibrous Dysplasia

Modality: monoclonal antibody

Target: denosumab

Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Source URL: ClinicalTrials.gov

Source updated: Jan 20, 2026

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by target_normalized: denosumab

View original source fields

Condition raw: Fibrous Dysplasia

Condition normalized: Fibrous Dysplasia

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: denosumab

Target normalized: denosumab

Open report

NCT01464931

Source recordAI-normalized

An Open-label Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg Administered Subcutaneously in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis

AI analysis

Indication: Renal Impairment

Modality: monoclonal antibody

Target: Denosumab

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Feb 19, 2016

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by target_normalized: Denosumab

View original source fields

Condition raw: Renal Impairment

Condition normalized: Renal Impairment

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab

Target normalized: Denosumab

Open report

NCT02049866

Source recordAI-normalized

Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)

The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis. Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months). The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women. Funding Source: FDA Office of Orphan Products Development (OOPD).

AI analysis

Indication: Adult Idiopathic Generalized Osteoporosis

Modality: monoclonal antibody

Target: Denosumab

Sponsor: Elizabeth Shane

Source URL: ClinicalTrials.gov

Source updated: Dec 12, 2022

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by target_normalized: Denosumab

View original source fields

Condition raw: Adult Idiopathic Generalized Osteoporosis

Condition normalized: Adult Idiopathic Generalized Osteoporosis

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab

Target normalized: Denosumab

Open report

NCT02352753

Source recordAI-normalized

To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI

This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.

AI analysis

Indication: Osteogenesis Imperfecta

Modality: monoclonal antibody

Target: Denosumab

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Dec 28, 2022

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by target_normalized: Denosumab

View original source fields

Condition raw: Osteogenesis Imperfecta

Condition normalized: Osteogenesis Imperfecta

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab

Target normalized: Denosumab

Open report

NCT03174366

Source recordAI-normalized

Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy

Charcot neuroarthropathy (CN) is a debilitating disease primarily affecting poorly controlled diabetic patients with peripheral neuropathy. The consequences of CN include ulcerations of the foot and ankle, osteomyelitis, and severe musculoskeletal deformity. These consequences frequently lead to below-knee amputation of the affected limb. Currently treatment options are limited, and no pharmaceutical treatment has been efficacious in the medical literature. The purpose of this pilot study is to investigate the potential of the medication denosumab for acute stage Charcot neuroarthropathy.

AI analysis

Indication: Charcot Joint of Foot

Modality: monoclonal antibody

Target: Denosumab

Sponsor: Western University of Health Sciences

Source URL: ClinicalTrials.gov

Source updated: Oct 23, 2019

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by target_normalized: Denosumab

View original source fields

Condition raw: Charcot Joint of Foot

Condition normalized: Charcot Joint of Foot

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab

Target normalized: Denosumab

Open report

NCT02435147

Source recordAI-normalized

Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index

This study evaluated the long-term effects of denosumab on trabecular bone score (TBS) and femur strength index (FSI) in postmenopausal women with osteoporosis. Conducted by HealthEast Care System, the observational study involved 86 participants, with 75 completing the study. The findings support denosumab's role in improving bone health metrics over 36 months.

AI analysis

Indication: Osteoporosis

Modality: monoclonal antibody

Target: denosumab

Sponsor: HealthEast Care System

Source URL: ClinicalTrials.gov

Source updated: Oct 29, 2018

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by target_normalized: denosumab

View original source fields

Condition raw: Osteoporosis, Bone Fracture

Condition normalized: Osteoporosis, Bone Fracture

Modality raw: small molecule

Modality normalized: monoclonal antibody

Target raw: denosumab

Target normalized: denosumab

Open report