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This study plans to enroll 72 healthy female volunteers. Subjects will be randomized into 1 of 3 treatment arms. The impact of the Investigational Prodcuct on relevant cellular biomarkers in the human breast will be evaluated.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Healthy Volunteer, Female, Breast
No treatment, Denosumab - low dose, Denosumab - high dose
Active, not recruiting
Published on BioPortfolio: 2014-10-27T22:08:22-0400
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 Produc
Approximately 140 male and female healthy subjects will be randomized (1:1 ratio) to receive a 120 mg single dose of denosumab either as a 1.7 mL single injection of 70 mg/mL denosumab CP4...
This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12 healthy male subjects will receive a subcutaneous injection of denosumab on Day 1. Subjects wil...
Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand that prevents recruitment and differentiation of mature osteoclasts. Treatment markedly decrease bone r...
The purpose of this study is to determine whether one dose of denosumab can lead to changes in the tumor, which may decrease the ability of tumor to spread.
Giant cell tumor of bone (GCTb) is a primary, osteolytic, benign tumor of the bone. Surgery is the commonly used treatment. Discovery of RANKL and its human monoclonal antibody, denosumab,...
The aim of this study was to determine whether osteonecrosis of the jaw (ONJ) developed more rapidly in patients who switched from bisphosphonates (BP) treatment to denosumab than in patients who rece...
The most widely used medications for the treatment of osteoporosis are currently bisphosphonates and denosumab. Both are antiresorptives, thus targeting the osteoclast and inhibiting bone resorption. ...
The clinical utility of denosumab for the treatment of glucocorticoid-induced osteoporosis (GIOP) has yet to be established. This study aimed to compare the effects of denosumab on bone mineral densit...
Aneurysmal bone cyst (ABC) is a benign bone tumor. Curettage and bone grafting is the common treatment. Here, we retrospectively evaluate nine patients treated with denosumab.
Denosumab (Prolia®; Pralia®) is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once every 6 months and is approved...
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
A treatment schedule in which the total dose of radiation is divided into large doses.
A humanized monoclonal antibody and an inhibitor of the RANK LIGAND, which regulates OSTEOCLAST differentiation and bone remodeling. It is used as a BONE DENSITY CONSERVATION AGENT in the treatment of OSTEOPOROSIS.
Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Track and monitor developments in breast cancer research and commercial development. Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...