A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-11-30

Brief Summary

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The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.

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Detailed Description

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Conditions

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Osteoporosis

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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100 mg AMG 162

Group Type ACTIVE_COMPARATOR

100 mg AMG 162

Intervention Type DRUG

100 mg AMG 162 (denosumab) SC every 6 months

60 mg AMG 162

Group Type ACTIVE_COMPARATOR

60 mg AMG 162

Intervention Type DRUG

60 mg AMG 162 (denosumab) SC every 6 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo SC every 6 months

14 mg AMG 162

Group Type ACTIVE_COMPARATOR

14 mg AMG 162

Intervention Type DRUG

14 mg AMG 162 (denosumab) SC every 6 months

Interventions

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100 mg AMG 162

100 mg AMG 162 (denosumab) SC every 6 months

Intervention Type DRUG

60 mg AMG 162

60 mg AMG 162 (denosumab) SC every 6 months

Intervention Type DRUG

14 mg AMG 162

14 mg AMG 162 (denosumab) SC every 6 months

Intervention Type DRUG

Placebo

Placebo SC every 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip.

Exclusion Criteria

Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No