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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-16

Study Completion Date

2018-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

NCT00896532

Low Bone Mineral Density Postmenopausal Osteoporosis

COMPLETED PHASE2

A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass

NCT00950950

Osteopenia

COMPLETED PHASE1

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

NCT01992159

Postmenopausal Osteoporosis (PMO)

COMPLETED PHASE2

A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

NCT02016716

Postmenopausal Osteoporosis

COMPLETED PHASE3

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)

NCT01825785

Postmenopausal Osteopenia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postmenopausal Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered by subcutaneous injections once a month

Romosozumab

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

Group Type EXPERIMENTAL

Romosozumab

Intervention Type DRUG

Administered by subcutaneous injection once a month (QM)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Romosozumab

Administered by subcutaneous injection once a month (QM)

Intervention Type DRUG

Placebo

Administered by subcutaneous injections once a month

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AMG 785 Evenity

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No