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A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis, Postmenopausal

Intervention: denosumab (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at 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

Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)

Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6

Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6

Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6

Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at 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

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6

Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 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

Change From Baseline in Hematocrit at Month 6

Change From Baseline in Mean Corpuscle Hemoglobin at Month 6

Change From Baseline in Mean Corpuscular Volume at Month 6

Change From Baseline in Red Blood Cell Count at Month 6

Change From Baseline in Red Cell Distribution Width at Month 6

Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 6

Eligibility

Minimum age: 55 Years. Maximum age: 75 Years. Gender(s): Female.

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

- any laboratory abnormality that will prevent the subject from completing the study or

interferes with interpretation of study results

- oral or dental conditions including current or past history of osteomyelitis or

osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery

- any disorder that compromises the ability of the subject to give written informed

consent or to comply with study procedures

- any physical or psychiatric disorder that will prevent the subject from completing

the study or interferes with study results

- known to have tested positive for HIV

- less than two lumbar vertebrae evaluable for DXA measurements

- height, weight, or girth that may preclude accurate DXA measurements

- drug or alcohol abuse within 12 months that interferes with understanding or

completing the study

- known sensitivity to mammalian cell-derived drug products

- use of an investigational drug or device within 30 days of enrollment or currently

receiving other investigational agent(s)

Locations and Contacts

GSK Investigational Site, Ahmedabad 380015, India

GSK Investigational Site, Bangalore 560052, India

GSK Investigational Site, Bangalore 560043, India

GSK Investigational Site, Bangalore 560054, India

GSK Investigational Site, Delhi 110060, India

GSK Investigational Site, Mangalore 575002, India

GSK Investigational Site, Nagpur 440010, India

GSK Investigational Site, Nagpur 440012, India

GSK Investigational Site, Pune 411030, India

GSK Investigational Site, Trivandrum 695011, India

GSK Investigational Site, Vadodra 390007, India

Additional Information

Starting date: January 2012
Last updated: January 9, 2014

Page last updated: August 23, 2015

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