Clinical trial NCT02791516: A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis.
Osteoporosis-Postmenopausal.
Bone Diseases-Metabolic.
Bone Diseases.
Musculoskeletal Diseases.
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-06-06
Enrollment: 67
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine
timeFrame: Baseline and month 6
Secondary outcomes:
measure: Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip
timeFrame: Baseline and month 6
measure: Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck
timeFrame: Baseline and month 6
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Namdong-gu, Incheon
country: Korea, Republic of
facility: Research Site
city: Seongnam Si Gyeonggi Do
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Baek KH, Chung YS, Koh JM, Kim IJ, Kim KM, Min YK, Park KD, Dinavahi R, Maddox J, Yang W, Kim S, Lee SJ, Cho H, Lim SK. Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study. Endocrinol Metab (Seoul). 2021 Feb;36(1):60-69. doi: 10.3803/EnM.2020.848. Epub 2021 Feb 24.