Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Amgen

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Placebo; Drug: AMG 162

Study type: Interventional

Funder types: Industry

Identifiers

NCT00091793

20040132

Details and patient eligibility

About

This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.

Enrollment: 332 patients

Sex: Female

Ages: Under 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria

• Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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332 participants in 2 patient groups, including a placebo group

AMG 162

Experimental group

Description:

60 mg/mL denosumab given day 1, month 6, month 12 and month 18

Treatment:

Drug: AMG 162

Placebo

Placebo Comparator group

Description:

Placebo given day 1, month 6, month 12 and month 18

Treatment:

Drug: Placebo