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Completed

NCT Number: NCT02791516

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

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

55 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Romosozumab

Drug

Administered by subcutaneous injection once a month (QM)

Other names: AMG 785, Evenity

Placebo

Drug

Administered by subcutaneous injections once a month

Primary outcomes

  1. Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine

    Time frame: Baseline and month 6

    Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.

Secondary outcomes

  1. Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip

    Time frame: Baseline and month 6

    Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.

  2. Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck

    Time frame: Baseline and month 6

    Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Postmenopausal South Korean Women With Osteoporosis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2016
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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