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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

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

Group Type EXPERIMENTAL

denosumab

Intervention Type DRUG

60mg subcutaneous injection, single dose

Arm 2

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo subcutaneous injection, single dose

Interventions

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denosumab

60mg subcutaneous injection, single dose

Intervention Type DRUG

placebo

placebo subcutaneous injection, single dose

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No