A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis

Amgen

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Placebo; Drug: Romosozumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02791516

20150242

Details and patient eligibility

About

The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.

Enrollment: 67 patients

Sex: Female

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.
• Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening.
• BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck.
• At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA.
• Other inclusion criteria may apply.

Exclusion criteria

• Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck.
• History of hip fracture.
• Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities.
• Known sensitivity or intolerance calcium and vitamin D products.
• Other exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo subcutaneous injection once a month for 6 months.

Treatment:

Drug: Placebo

Romosozumab

Experimental group

Description:

Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.

Treatment:

Drug: Romosozumab