A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women

Amgen

Status and phase: Completed; Phase 1

Conditions: Osteopenia

Treatments: Drug: Romosozumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01101061

20090378

Details and patient eligibility

About

The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.

Enrollment: 31 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Japanese subjects must be first (4 grandparents, biologic parents and subject born in Japan), second (4 grandparents and biological parents born in Japan) or third (4 grandparents born in Japan) generation Japanese
• Body mass index ≤ 25 kg/m², inclusive at screening
• Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available)

Exclusion criteria

• Osteoporosis, as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ -2.5
• History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis;
• Diagnosed with any condition that will affect bone metabolism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Romosozumab

Experimental group

Description:

Japanese women in cohorts 1, 2, and 4 will receive a single dose of 1, 3, or 5 mg/kg romosozumab. Non-Japanese women in cohort 3 will receive a single dose of 3 mg/kg romosozumab.

Treatment:

Drug: Romosozumab

Placebo

Placebo Comparator group

Description:

Participants will receive a single dose of placebo.

Treatment:

Drug: Placebo