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

GlaxoSmithKline1 site in 1 country250 target enrollmentJanuary 2012

ConditionsOsteoporosis, Postmenopausal

Interventionsdenosumab placebo

Overview

Phase: Phase 3
Intervention: denosumab
Conditions: Osteoporosis, Postmenopausal
Sponsor: GlaxoSmithKline
Enrollment: 250
Locations: 1
Primary Endpoint: Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6
Status: Completed
Last Updated: 12 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 Indian postmenopausal women with osteoporosis.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

February 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ambulatory Indian postmenopausal women with osteoporosis
•greater than 5 years postmenopausal
•aged 55 to 75 years old
•absolute bone mineral density value consistent with a T-score less than -2.5 and greater than - 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 or equal to -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 treatment

Intervention: denosumab

Arm 2

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

Intervention: placebo

Outcomes

Primary Outcomes

Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6

Time Frame: Baseline and Month 6

Bone mineral density (BMD) at the lumbar spine was measured by the dual-energy x-ray absorptiometry (DXA) scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) \* 100 / Baseline value. Analysis was performed using an Analysis of Covariance (ANCOVA) model with terms for treatment and baseline BMD at the lumbar spine (as a continuous covariate).

Secondary Outcomes

Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6(Baseline and Month 6)
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6(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 Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6(Baseline and Month 6)
Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6(Baseline; Months 1, 3, and 6)
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)(From Baseline up to Month 6)
Change From Baseline in Hematocrit at Month 6(Baseline and Month 6)
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6(Baseline; Months 1, 3, and 6)
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation 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 Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at Month 6(Baseline and Month 6)
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count 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 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 Positive and Negative Results for Anti-body Formation to Denosumab at Month 6(Month 6)