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

NCT ID: NCT01457950

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-06-30

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.

Conditions

Osteoporosis, Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

denosumab

Intervention Type: DRUG

double-blind phase: 60mg subcutaneous injection, single dose

Arm 2

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

double-blind phase: placebo subcutaneous injection, single dose

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

Group Type: EXPERIMENTAL

open-label denosumab

Intervention Type: DRUG

open-label phase: 60mg subcutaneous injection, single dose

Interventions

denosumab

double-blind phase: 60mg subcutaneous injection, single dose

Intervention Type: DRUG

placebo

double-blind phase: placebo subcutaneous injection, single dose

Intervention Type: DRUG

open-label denosumab

open-label phase: 60mg subcutaneous injection, single dose

Intervention Type: DRUG

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
• any laboratory abnormality that will prevent the subject from completing the study or interfere with interpretation of study results
• severe renal impairment or on dialysis
• impaired immune system or subject is taking immunosuppressants
• 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)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Busan, , South Korea

GSK Investigational Site

Daegu, , South Korea

GSK Investigational Site

Gwangju, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Songpa-gu, Seoul, , South Korea

GSK Investigational Site

Suwon, , South Korea

Countries

South Korea

Other Identifiers

114163

Identifier Type: -

Identifier Source: org_study_id