Up-to-date List of Prolia Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Prolia Medical Research Studies

RankStatusStudy
1 Recruiting AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Patients With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: denosumab;   Drug: placebo
Outcome Measures: Change from baseline in Total Sharp Score (TSS) at month 12;   change form baseline in TSS at month 6;   change form baseline in Erosion Score at month 6;   change form baseline in Joint Space Narrowing at month 6;   change form baseline in Erosion Score at month 12;   change form baseline in Joint Space Narrowing at month 12;   percent change from baseline in Bone Mineral Density (BMD) at month 12
2 Recruiting Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip Arthroplasty
Condition: Revision Surgery of Total Hip Arthroplasty
Interventions: Drug: Denosumab;   Other: Placebo
Outcome Measures: Osteoclast number;   Change in serum or urine levels of βCTXI, NTXI/Cr, TRAcP5b, CTXMMP, PINP, OPG, RANKL;   Difference between the denosumab and placebo groups in mean eroded, quiescent, and osteoblast surfaces at the membrane bone interface;   Difference between the denosumab and placebo groups in ratio of viable to apoptotic osteoclast, macrophage fibroblast, and osteoblasts by TUNEL staining and relative number of cells staining positive for apoptosis markers
3 Recruiting Denosumab in Primary Hyperparathyroidism
Condition: Primary Hyperparathyroidism
Interventions: Drug: Denosumab;   Other: Placebo
Outcome Measures: Change in Bone Mineral Density (BMD) at the lumbar spine;   Change in Bone Mineral Density (BMD) at the distal 1/3 radius;   Change in Bone Mineral Density (BMD) at the hip
4 Not yet recruiting Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks
Conditions: Metastatic Breast Cancer;   Metastatic Prostate Cancer;   Bone Metastases
Interventions: Drug: Denosumab (reduced dosing);   Drug: Denosumab (standard dosing)
Outcome Measures: Time to first on-trial symptomatic skeletal event (SSE; Clinically significant pathological fracture, radiation therapy to bone, surgery to bone or spinal cord compression).;   Toxicity (focus on hypocalcaemia and osteonecrosis of the jaw);   Time to first and subsequent on-trial SSE;   Quality of Life;   Skeletal morbidity period rate (SMPR);   Skeletal morbidity rate (SMR);   Health economic analysis;   Bone turnover marker change;   Overall Survival (OS)
5 Recruiting The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab
Condition: Osteoporosis Treatment
Interventions: Drug: 18 months teriparatide followed by 18 months denosumab;   Drug: three separate 6 month cycles of daily teriparatide, each followed by one of denosumab
Outcome Measures: spine bone density;   bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg
6 Not yet recruiting Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
Condition: Adult Idiopathic Generalized Osteoporosis
Intervention: Drug: Denosumab
Outcome Measure: Percent change in lumbar spine areal BMD by DXA
7 Not yet recruiting Denosumab Administration After Spinal Cord Injury
Conditions: Osteoporosis;   Spinal Cord Injury
Interventions: Drug: Denosumab;   Drug: Placebo (identical Densoumab volume of normal saline)
Outcome Measures: Bone mineral density (BMD) of the distal femur;   Bone microarchitecture of the distal femur and proximal tibia.
8 Not yet recruiting Denosumab for Breast Cancer With Bone Mets
Condition: Breast Cancer
Intervention: Drug: Denosumab
Outcome Measure: Reduction of Circulating Tumor Cells (CTCs)
9 Recruiting A Double-Blind, Randomized, Single-Dose, Parallel-Group Study in Healthy Volunteers to Assess the Bioequivalence of a 120 mg Denosumab Subcutaneous Dose When Administered as Denosumab CP4 Drug Product or as Commercially Available Denosumab CP2 Drug Product
Condition: Healthy Volunteer
Interventions: Drug: Drug Product CP4;   Drug: Drug Product CP2
Outcome Measure: PK parameters AUC0-18 weeks and Cmax
10 Recruiting Anakinra or Denosumab and Everolimus in Advanced Cancer
Condition: Advanced Cancers
Interventions: Drug: Everolimus;   Drug: Anakinra;   Drug: Denosumab
Outcome Measure: Maximum Tolerated Dose (MTD)
11 Unknown  Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients
Conditions: Osteoporosis;   Chronic Kidney Disease
Intervention: Drug: Denosumab (Prolia)
Outcome Measures: Total hip bone mineral density (BMD) after one year of treatment;   Occurrence of fractures
12 Recruiting Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women
Condition: Hip Osteoarthritis
Interventions: Drug: Denosumb;   Drug: Placebo (for denosumab)
Outcome Measures: DXA measurement of periprosthetic BMD;   RSA measurement of prosthesis stem migration
13 Recruiting A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer
Condition: Breast Neoplasms
Intervention: Drug: Denosumab
Outcome Measures: Geometric mean change in tumor Ki67 expression;   Absolute Ki67 responders;   C-terminal telopeptide (CTX) serum levels;   RANK/RANKL gene expression and signalling;   gene expression (AURKA, Ki-67,GGI);   TUNEL and caspase-3 apoptosis markers;   expression of immature mammary epithelial cell population: MaSCs, luminal progenitors , ALDH1;   gene expression of the estrogen pathways (i.e. ESR1, PgR, BCL2) and estrogen-related gene expression modules (i.e. ESR module);   immune related genes;   Quantity of tumor infiltrating lymphocytes;   Safety and tolerability of a short course of denosumab
14 Recruiting Effect of RANKL Inhibition on UV-induced Immunosuppression
Conditions: Ultraviolet Rays;   Immunosuppression;   Hypersensitivity, Delayed;   Immune Tolerance/Drug Effects
Interventions: Drug: Denosumab;   Radiation: UVB exposure;   Drug: Diphenylcyclopropenone;   Drug: Normal Saline
Outcome Measures: Change in dermal thickness: denosumab group vs placebo group of Cohort 2;   Clinical score of contact hypersensitivity reactions: denosumab group vs placebo group of Cohort 2;   Diameters of contact hypersensitivity reactions: denosumab group vs placebo group of Cohort 2;   Change in dermal thickness: non UV-exposed (Cohort 1) vs UV-exposed (Cohort 2);   Clinical score of contact hypersensitivity reactions: non UV-exposed (Cohort 1) vs UV-exposed (Cohort 2);   Diameters of contact hypersensitivity reactions: non UV-exposed (Cohort 1) vs UV-exposed (Cohort 2);   Gene expression levels: denosumab group vs placebo group of Cohort 2;   Histological pattern of expression of RANKL and other proteins of interest: denosumab group vs placebo group of Cohort 2
15 Not yet recruiting RA Denosumab on Bone Microstructure Study
Condition: Rheumatoid Arthritis
Interventions: Drug: Denosumab;   Drug: Alendronate
Outcome Measures: Changes from baseline in bone volumetric density at distal radius at 6th month;   Changes from baseline in trabecular bone microarchitecture at distal radius at 6th month;   Changes from baseline in bone volumetric density at the 2nd metacarpal bone at 6th month;   Changes from baseline in trabecular bone microarchitecture at 2nd metacarpal bone at 6th month;   Changes from baseline in areal bone density at total hip at 6th month;   Changes from baseline in areal bone density at lumbar spine at 6th month;   Changes in areal bone density at distal radius at 6th month;   Changes from baseline in bone volumetric density at distal radius at 3rd month;   Changes from baseline in trabecular bone microarchitecture at distal radius at 3rd month;   Changes from baseline in bone volumetric density at the 2nd metacarpal bone at 3rd month;   Changes from baseline in trabecular bone microarchitecture at 2nd metacarpal bone at 3rd month;   Changes from baseline in areal bone density at total hip at 3rd month;   Changes from baseline in areal bone density at lumbar spine at 3rd month;   Changes in areal bone density at distal radius at 3rd month
16 Not yet recruiting Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy
Condition: Lung Cancer Non-small Cell Stage IV
Interventions: Drug: Denosumab;   Other: None, standard chemotherapy only
Outcome Measures: Overall survival;   Progression-free survival (PFS) based on RECIST 1.1;   Response based on RECIST 1.1;   Toxicity profile of denosumab;   Evaluation of potential predictive biomarkers for denosumab activity
17 Recruiting Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: Denosumab;   Drug: Zometa
Outcome Measures: Relative benefit on overall survival (OS);   Tumor tissue RANK expression in correlation with objective response rate (CR+PR) based on modified RECIST 1.1;   Tumor tissue RANKL expression in correlation with overall survival;   Tumor tissue RANKL expression in correlation with objective response (CR + PR);   Objective response, clinical benefit rate & progression-free survival based on modified RECIST 1.1;   Serum denosumab trough levels;   Treatment-emergent adverse events
18 Not yet recruiting A Study to Compare Denosumab With Zoledronic Acid in Subjects With Bone Metastases From Solid Tumors
Condition: Fractures, Bone
Interventions: Biological: Denosumab 70 mg/mL;   Drug: Zoledronic acid 4 mg;   Drug: Placebo IV;   Drug: Placebo SC
Outcome Measures: Percent change from Baseline in the bone turnover marker (BTM) uNTx/uCr;   Percent change from Baseline in bone-specific alkaline phosphatase (s-BALP);   Safety and tolerability assessment for adverse events (AEs);   Safety and tolerability assessment for Laboratory tests;   Safety and tolerability assessment for Incidence of anti-denosumab antibodies;   Pharmacokinetic properties of serum concentrations of denosumab
19 Recruiting Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer
Condition: Early Stage Breast Cancer
Intervention: Drug: Denosumab
Outcome Measures: Reduction of bone marrow DTC;   Disseminated tumor cell counts
20 Recruiting Study of Denosumab in Subjects With Giant Cell Tumor of Bone
Conditions: Cancer;   GCT;   Giant Cell Tumor of Bone;   Benign GCT
Intervention: Drug: Denosumab
Outcome Measures: Safety profile of denosumab characterized in terms of the type, frequency, and severity of adverse events and laboratory abnormalities for each cohort.;   Time to disease progression for Cohort 1;   Proportion of subjects without any surgery at month 6 for Cohort 2;   Evaluate denosumab pharmacokinetics in adolescent and adult subjects with GCTB (PK subset)

These studies may lead to new treatments and are adding insight into Prolia etiology and treatment.

A major focus of Prolia research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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