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

Amgen

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: Placebo; Drug: 100 mg AMG 162; Drug: 14 mg AMG 162; Drug: 60 mg AMG 162

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306189

NOT APPRICABLE

20050172

Details and patient eligibility

About

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.

Enrollment: 212 patients

Sex: Female

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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: - 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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212 participants in 4 patient groups, including a placebo group

100 mg AMG 162

Active Comparator group

Treatment:

Drug: 100 mg AMG 162

60 mg AMG 162

Active Comparator group

Treatment:

Drug: 60 mg AMG 162

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

14 mg AMG 162

Active Comparator group

Treatment:

Drug: 14 mg AMG 162