- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05067335
A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Beijing, China
- Op0002 20040
-
Beijing, China
- Op0002 20115
-
Beijing, China
- Op0002 20125
-
Beijing, China
- Op0002 20127
-
Beijing, China
- Op0002 20128
-
Beijing, China
- Op0002 20130
-
Beijing, China
- Op0002 20131
-
Beijing, China
- Op0002 20157
-
Chengdu, China
- Op0002 20021
-
Chengdu, China
- Op0002 20133
-
Chengdu, China
- Op0002 20137
-
Foshan, China
- Op0002 20205
-
Guangzhou, China
- Op0002 20117
-
Guangzhou, China
- Op0002 20124
-
Nanchang, China
- Op0002 20209
-
Nanjing, China
- Op0002 20135
-
Pingxiang, China
- Op0002 20202
-
Rui'an, China
- Op0002 20199
-
Shanghai, China
- Op0002 20116
-
Shanghai, China
- Op0002 20118
-
Shanghai, China
- Op0002 20121
-
Shanghai, China
- Op0002 20123
-
Shanghai, China
- Op0002 20129
-
Suzhou, China
- Op0002 20119
-
Suzhou, China
- Op0002 20204
-
Tianjin, China
- Op0002 20122
-
Tianjin, China
- Op0002 20136
-
Wuhan, China
- Op0002 20120
-
Yueyang, China
- Op0002 20134
-
Zhengzhou, China
- Op0002 20132
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subject is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator
- Subject is an ambulatory postmenopausal Chinese women, 55 to 90 years of age (inclusive) at the time of Screening. Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to Screening
- Subject has a bone mineral density (BMD) T-score ≤-2.50 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of Screening based on DXA scans, and using data for Caucasian women from the National Health and Nutritional Examination Survey (NHANES, 1998)
Subject must have at least 1 of following independent risk factors for fracture:
- History of fragility fracture (except hip fracture, a severe vertebral fracture or more than 2 moderate vertebral fractures)
- Parental history of hip fracture
- Low body weight (body mass index ≤19kg/m2)
- Elderly (age ≥ 65 years)
- Current smoker
- Subject has at least 2 vertebrae in the L1 to L4 region and at least 1 hip that are evaluable by dual-energy x-ray absorptiometry (DXA), as assessed by the central imaging vendor
Exclusion Criteria:
- Subject has a BMD T-score of ≤-3.50 at the total hip or femoral neck, as assessed by the central imaging vendor at the time of Screening based on DXA scans, and using data for Caucasian women from NHANES 1998
- Subject has a known history of hip fracture
- Subject has any severe (SQ3) or more than 2 moderate (SQ2) vertebral fractures, as assessed by the central imaging vendor based on the lateral spine x-ray at Screening
- Subject has a history of myocardial infarction (MI)
- Subject has a history of stroke
- Subject has a vitamin D insufficiency, defined as 25 (OH) vitamin D levels <20 ng/mL, as assessed by the central laboratory at Screening. Vitamin D repletion will be permitted and the subject may be retested once within the Screening Period
Subject has used oral bisphosphonates:
- Any doses received within 3 months prior to randomization
- More than 1 month of cumulative use between 3 and 12 months prior to randomization
- More than 3 years of cumulative use, unless the last dose was received ≥5 years prior to randomization
Subject has used intravenous (iv) bisphosphonates:
zoledronic acid
- Any doses received within 3 years prior to randomization
- More than 1 dose received within 5 years prior to randomization
iv ibandronate, iv pamidronate, or iv alendronate (ALN)
- Any doses received within 12 months prior to randomization
- More than 3 years of cumulative use, unless the last dose was received ≥5 years prior to randomization
Subject has used denosumab or any cathepsin K inhibitor:
● Any doses received within 18 months prior to randomization
Subject has used tibolone, cinacalcet, or calcitonin:
- Any doses received within 3 months prior to randomization
Subject has used teriparatide (TPTD) or any parathyroid hormone (PTH) derivative:
- Any doses received within 3 months prior to randomization
- More than 1 month of cumulative use between 3 and 12 months prior to randomization
Subject has used systemic oral or transdermal estrogen or selective estrogen receptor modulators (SERMs):
● More than 1 month of cumulative use within 6 months prior to randomization
Subject has used strontium ranelate or fluoride:
● More than 1 month of cumulative use within 5 years prior to randomization
Subject has used hormonal ablation therapy:
● More than 1 month of cumulative use within 6 months prior to randomization
Subject has used systemic glucocorticosteroids:
● ≥5mg prednisone equivalent per day for more than 14 days within 3 months prior to randomization
- Subject has a history of osteonecrosis of the jaw (ONJ) or atypical femoral fracture (AFF)
Subject has evidence of any of the following:
- Current, uncontrolled hyper- or hypothyroidism. Uncontrolled hyperthyroidism is defined as thyroid-stimulating hormone (TSH) and thyroxine (T4) outside of the normal range. Uncontrolled hypothyroidism is defined as TSH >10
- Current, uncontrolled hyperparathyroidism or history of hypoparathyroidism. Uncontrolled hyperparathyroidism is defined as PTH outside the normal range in subjects with concurrent hypercalcemia or PTH values >20 % above upper limit of normal (ULN) in normocalcemic subjects
- Current hypercalcemia or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory at the time of Screening. Albumin-adjusted serum calcium levels may be retested once in case of an elevated albumin-adjusted serum calcium level within 1.1xULN of the laboratory's reference ranges
- Subject has ≥3xULN of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35 %)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Romosozumab
Subjects randomized to this arm will receive romosozumab during all treatment Periods.
|
Subjects will receive romosozumab in a specified sequence during the treatment Period.
|
Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo during the Double-Blind-Placebo controlled Period and romosozumab during the Open-Label treatment Period
|
Subjects will receive romosozumab in a specified sequence during the treatment Period.
Subjects will receive Placebo in a specified sequence during the treatment Period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent change from Baseline in bone mineral density (BMD) at the lumbar spine
Time Frame: From Baseline to the end of the Double-Blind, Placebo-Controlled Period (Month 6)
|
Percent change from Baseline in bone mineral density (BMD) at the lumbar spine at the end of the Double-Blind, Placebo-Controlled Period (Month 6) as assessed by dual-energy x-ray absorptiometry (DXA) by treatment group.
|
From Baseline to the end of the Double-Blind, Placebo-Controlled Period (Month 6)
|
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: From Baseline to the end of the Double-Blind, Placebo-Controlled Period (Month 6)
|
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
From Baseline to the end of the Double-Blind, Placebo-Controlled Period (Month 6)
|
Incidence of treatment-emergent adverse events (TEAEs) during the Open-Label Treatment Period
Time Frame: From the Open-Label Treatment Period up to Month 15
|
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
From the Open-Label Treatment Period up to Month 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent change from Baseline in bone mineral density (BMD) at the total hip
Time Frame: From Baseline to the end of the Double-Blind, Placebo-Controlled Period (Month 6)
|
Percent change from Baseline in bone mineral density (BMD) at the total hip at the end of the Double-Blind, Placebo-Controlled Period (Month 6) as assessed by dual-energy x-ray absorptiometry (DXA) by treatment group.
|
From Baseline to the end of the Double-Blind, Placebo-Controlled Period (Month 6)
|
Percent change from Baseline in bone mineral density (BMD) at the femoral neck
Time Frame: From Baseline to the end of the Double-Blind, Placebo-Controlled Period (Month 6)
|
Percent changes from Baseline in bone mineral density (BMD) at the femoral neck at the end of the Double-Blind, Placebo-Controlled Period (Month 6) as assessed by dual-energy x-ray absorptiometry (DXA) by treatment group.
|
From Baseline to the end of the Double-Blind, Placebo-Controlled Period (Month 6)
|
Percent change from Baseline in bone mineral density (BMD) at the lumbar spine at the end of the Open-Label Treatment Period
Time Frame: From Baseline to the end of the Open-Label Extension (OLE) Period (Month 12)
|
Percent change from Baseline in bone mineral density (BMD) at the lumbar spine, at the end of OLE Period (Month 12) as assessed by dual-energy x-ray absorptiometry (DXA) in subjects who are continuing with 6 months of romosozumab treatment after initially being randomized to 6 months of romosozumab treatment in the Double-Blind, Placebo-Controlled Period (for a total of 12 months of romosozumab treatment).
|
From Baseline to the end of the Open-Label Extension (OLE) Period (Month 12)
|
Percent change from Baseline in bone mineral density (BMD) at the total hip at the end of the Open-Label Treatment Period
Time Frame: From Baseline to the end of the Open-Label Extension (OLE) Period (Month 12)
|
Percent change from Baseline in bone mineral density (BMD) at the total hip, at the end of OLE Period (Month 12) as assessed by dual-energy x-ray absorptiometry (DXA) in subjects who are continuing with 6 months of romosozumab treatment after initially being randomized to 6 months of romosozumab treatment in the Double-Blind, Placebo-Controlled Period (for a total of 12 months of romosozumab treatment).
|
From Baseline to the end of the Open-Label Extension (OLE) Period (Month 12)
|
Percent change from Baseline in bone mineral density (BMD) at the femoral neck at the end of the Open-Label Treatment Period
Time Frame: From Baseline to the end of the Open-Label Extension (OLE) Period (Month 12)
|
Percent change from Baseline in bone mineral density (BMD) at the femoral neck, at the end of OLE Period (Month 12) as assessed by dual-energy x-ray absorptiometry (DXA) in subjects who are continuing with 6 months of romosozumab treatment after initially being randomized to 6 months of romosozumab treatment in the Double-Blind, Placebo-Controlled Period (for a total of 12 months of romosozumab treatment).
|
From Baseline to the end of the Open-Label Extension (OLE) Period (Month 12)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OP0002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoporosis
-
Radius Health, Inc.CompletedOsteoporosis | Osteoporosis Risk | Osteoporosis, Postmenopausal | Osteoporosis Fracture | Osteoporosis, Age-Related | Osteoporosis Localized to Spine | Osteoporosis Senile | Osteoporosis of Vertebrae | Osteoporosis VertebralUnited States
-
Radius Health, Inc.CompletedOsteoporosis | Age Related Osteoporosis | Osteoporosis, Age-Related | Osteoporosis Localized to Spine | Osteoporosis Senile | Osteoporosis of VertebraeUnited States, Poland, Italy
-
Hoffmann-La RocheCompletedPostmenopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States, Puerto Rico
-
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceRecruitingPost Menopausal OsteoporosisFrance
-
AmgenCompletedPost Menopausal OsteoporosisFrance
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisSpain, South Africa, Germany, Mexico, United States, Canada, France, United Kingdom, Italy, Belgium, Australia, Poland, Denmark, Hungary, Czech Republic, Norway
-
Hoffmann-La RocheGlaxoSmithKlineCompletedPost Menopausal OsteoporosisFrance
-
Novartis PharmaceuticalsCompletedPost-menopausal OsteoporosisColombia, Belgium, Sweden, Hong Kong, United States, Hungary, Switzerland, Australia, Germany, Italy, Canada, Poland, Argentina, Thailand, Norway, New Zealand, France, Finland
Clinical Trials on Romosozumab
-
AmgenRecruitingPostmenopausal OsteoporosisIndia
-
Memorial Sloan Kettering Cancer CenterRecruitingMultiple Myeloma | OsteoporosisUnited States
-
AmgenUCB PharmaCompletedFracture HealingCanada, Italy, United States, Russian Federation, France, Germany, Hong Kong, Hungary, Australia, Bulgaria, Poland, Romania, Greece, Denmark, Estonia, India, New Zealand, United Kingdom, Latvia, Slovakia, Lithuania, Mexico, Norway
-
AmgenCompletedPostmenopausal OsteoporosisKorea, Republic of
-
AmgenCompleted
-
AmgenCompleted
-
AmgenCompletedOsteoporosis in MenUnited States, Belgium, Colombia, Czechia, Denmark, Japan, Mexico, Poland, Russian Federation, Switzerland
-
AmgenCompleted