Loading clinical trials...

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women

A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 162 Administered Subcutaneously to Japanese Postmenopausal Women

NCT03822078•Amgen

View on ClinicalTrials.gov

Summary

The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.

Eligibility

Age

All ages

Sex

All

Healthy Volunteers

Inclusion Criteria

•ambulatory women between the ages of 40 and 64 years, inclusive
•postmenopausal, defined as amenorrheic for at least 24 months
•clinically acceptable physical exam
•clinical laboratory tests (complete blood count \[CBC\], blood chemistries, urinalysis) within normal limits or clinically acceptable to the investigator/sponsor at the time of screening with the exception of aspartate transaminase (AST) and alkaline phosphatase (ALT), which must be \< 1.25 times the upper limit of normal, or gamma-glutamyl transpeptidase (GGT), which must be \< 1.5 times the upper limit of normal
•normal or clinically acceptable electrocardiogram (ECG) (12-lead reporting ventricular rate and PR, QRS, QT, and QTc intervals)
•body mass index between 17 and 27
•willing to sign an approved informed consent form before any study-specific assessments and oral consultations are performed

Exclusion Criteria

•administration of medications within 6 months before investigational product administration that are known to effect bone metabolism, including but not limited to the following: calcitonin, parathyroid hormone (or any derivative), supplemental vitamin D (\> 1000 IU/day), glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the date of informed consent were allowed), anabolic steroids, calcitriol and available analogues, diuretics
•administration of the following medications within 12 months before study drug administration: bisphosphonates, fluoride for osteoporosis
•diagnosed with any condition that affects bone metabolism
•greatly differing levels of physical activity compared with the 6 months before investigational product administration or constant levels of intense physical activities
•routine alcohol intake of ≥ 2 drinks/day, on average, within 6 months of investigational product administration
•known sensitivity to any drugs
•positive test results for hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus antigen/antibody, syphilis
•receiving or received any investigational drug (or was currently using an investigational device) within 4 months before receiving investigational product
•donated any amount of blood within 16 weeks, or over 400 mL (Note: not 400 mL but 200 mL, for the subjects who were to be enrolled into cohorts 4 or 5) within 1 year of the start day of screening
•subject had previously entered this study
+1 more criteria

Key Dates

Start Date

September 30, 2003

Primary Completion Date

December 24, 2004

Completion Date

December 24, 2004

Last Updated

July 24, 2019

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

Placebo

DRUG

Denosumab

BIOLOGICAL

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

View study

RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

NCT07281586

Osteoporosis

View study

RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project

Automated Bone Age Estimation From Noncontrast Abdominal CT Using Deep Learning

Effect of Mechanical Loading and Bone Loss on Motor Neuron Activity-H-Reflex Relationship

Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device