Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

Amgen

Status and phase: Completed; Phase 2

Conditions: Postmenopausal Osteoporosis (PMO)

Treatments: Drug: Romosozumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01992159

20101291

Details and patient eligibility

About

The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Enrollment: 252 patients

Sex: Female

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)

Exclusion criteria

• Severe osteoporosis
• Use of agents affecting bone metabolism
• History of metabolic or bone disease (except osteoporosis)
• Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
• Current hyper- or hypocalcemia
• Current, uncontrolled hyper- or hypothyroidism
• Current, uncontrolled hyper- or hypoparathyroidism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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252 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.

Treatment:

Drug: Placebo

Romosozumab 70 mg

Experimental group

Description:

Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Treatment:

Drug: Romosozumab

Romosozumab 140 mg

Experimental group

Description:

Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Treatment:

Drug: Romosozumab

Romosozumab 210 mg

Experimental group

Description:

Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Treatment:

Drug: Romosozumab