Postmenopausal Osteoporosis Clinical Trial
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
Verified date | September 2019 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | December 21, 2018 |
Est. primary completion date | February 12, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 55 Years to 90 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Research Site | Busan | |
Korea, Republic of | Research Site | Gwangju | |
Korea, Republic of | Research Site | Namdong-gu, Incheon | |
Korea, Republic of | Research Site | Seongnam Si Gyeonggi Do | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Suwon-si, Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Amgen |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine | Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Baseline and month 6 | |
Secondary | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip | Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Baseline and month 6 | |
Secondary | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck | Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Baseline and month 6 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05902078 -
Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
|
Phase 4 | |
Completed |
NCT05087030 -
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
|
Phase 3 | |
Completed |
NCT01544894 -
Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
|
Phase 4 | |
Completed |
NCT00381251 -
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
|
Phase 1 | |
Completed |
NCT00377819 -
Study of Transitioning From Alendronate to Denosumab
|
Phase 3 | |
Completed |
NCT00239629 -
Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial
|
Phase 4 | |
Completed |
NCT04026256 -
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
|
Phase 4 | |
Terminated |
NCT00529373 -
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
|
Phase 3 | |
Completed |
NCT00092014 -
A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)
|
Phase 3 | |
Recruiting |
NCT06079476 -
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
|
Phase 4 | |
Not yet recruiting |
NCT04719650 -
Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid
|
Phase 4 | |
Recruiting |
NCT02981732 -
CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome
|
N/A | |
Completed |
NCT01709110 -
VERtebral Fracture Treatment Comparisons in Osteoporotic Women
|
Phase 4 | |
Completed |
NCT01348243 -
Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis
|
Phase 3 | |
Completed |
NCT00541658 -
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
|
Phase 3 | |
Completed |
NCT00395395 -
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women
|
Phase 1 | |
Completed |
NCT00247273 -
A Study of Monthly Risedronate for Osteoporosis
|
Phase 3 | |
Active, not recruiting |
NCT03720886 -
G56W1 in Women With Postmenopausal Osteoporosis
|
Phase 1/Phase 2 | |
Completed |
NCT01668589 -
Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis
|
N/A | |
Completed |
NCT04664959 -
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
|
Phase 3 |