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A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT01495000•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

55 - 75 years

Sex

FEMALE

Healthy Volunteers

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
+10 more criteria

Locations (11)

GSK Investigational Site

Ahmedabad, India

GSK Investigational Site

Bangalore, India

GSK Investigational Site

Bangalore, India

GSK Investigational Site

Bangalore, India

GSK Investigational Site

Delhi, India

GSK Investigational Site

Mangalore, India

GSK Investigational Site

Nagpur, India

GSK Investigational Site

Nagpur, India

GSK Investigational Site

Pune, India

GSK Investigational Site

Trivandrum, India

Key Dates

Start Date

January 1, 2012

Primary Completion Date

February 1, 2013

Completion Date

February 1, 2013

Last Updated

February 7, 2014

Enrollment

250

ACTUAL participants

Conditions

Osteoporosis, Postmenopausal

Interventions

denosumab

DRUG

placebo

DRUG

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

NCT05575167

Osteoporosis, Postmenopausal

View study

RECRUITINGNA

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

NCT05228262

Osteoporosis, Postmenopausal

View study

WITHDRAWNPHASE4

Effect of Mechanical Loading With PTH on Cortical Bone

NCT03232476

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: February 7, 2014Data 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.

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

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Efficacy and Safety of MW031 in PMO Subjects