A Six Month Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study With a Six Month Open-Label Extension to Evaluate the Efficacy and Safety of Denosumab in Korean Postmenopausal Women With Osteoporosis

GlaxoSmithKline1 site in 1 country135 target enrollmentNovember 2011

ConditionsOsteoporosis, Postmenopausal

Interventionsdenosumab placebo open-label denosumab

Drugsdenosumab placebo open-label denosumab

Overview

Phase: Phase 3
Intervention: denosumab
Conditions: Osteoporosis, Postmenopausal
Sponsor: GlaxoSmithKline
Enrollment: 135
Locations: 1
Primary Endpoint: Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

June 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ambulatory Korean postmenopausal women with osteoporosis
•greater than 5 years postmenopausal
•aged 60 to 90 years old
•absolute bone mineral density value consistent with a T-score less than -2.5 and greater than or equal to - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0 are at very high risk for fracture and will be excluded.

Exclusion Criteria

•previous or current metabolic bone disease, Paget's or Cushing's disease, or hyperprolactinemia
•current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria
•rheumatoid arthritis
•cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal
•medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates
•medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists
•malignancy within 5 years except certain resected types
•malabsorption syndrome or gastrointestinal disorders associated with malabsorption
•abnormal calcium level
•vitamin D deficiency

Arms & Interventions

Arm 1

denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase

Intervention: denosumab

Arm 2

placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase

Intervention: placebo

Arm 3

open-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase

Intervention: open-label denosumab

Outcomes

Primary Outcomes

Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6

Time Frame: Baseline and Month 6

Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline \* 100.

Secondary Outcomes

Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1(Baseline and Month 1)
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6(Baseline, Month 1 and Month 6)
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)(From Baseline up to Month 6)
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6(Baseline and Month 6)
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6(Baseline and Month 6)
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6(Baseline and Month 6)
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6(Baseline and Month 6)
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6(Baseline and Month 6)
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6(Baseline and Month 6)
Change From Baseline in Hematocrit at Month 6(Baseline and Month 6)
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6(Baseline and Month 6)
Change From Baseline in Mean Corpuscular Volume at Month 6(Baseline and Month 6)
Change From Baseline in Red Blood Cell Count at Month 6(Baseline and Month 6)
Change From Baseline in Red Cell Distribution Width at Month 6(Baseline and Month 6)
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6(Baseline and Month 6)
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab(Month 6)
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6(Baseline, Months 1, 3 and 6)