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
1 other identifier
interventional
327
1 country
30
Brief Summary
The purpose of the study is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in bone mineral density (BMD) at the lumbar spine, at the total hip and femoral neck in postmenopausal Chinese women with osteoporosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2021
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2021
CompletedFirst Posted
Study publicly available on registry
October 5, 2021
CompletedStudy Start
First participant enrolled
October 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2023
CompletedResults Posted
Study results publicly available
December 5, 2024
CompletedDecember 5, 2024
October 1, 2024
2.1 years
September 23, 2021
November 8, 2024
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine to the End of Double-Blind Period
Percent change from baseline in BMD at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA) at 6 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the last observation carried forward (LOCF) approach. Missing or out of window (exceed 70 days since previous IMP) post-baseline DXA BMD due to COVID-19 were set to missing and imputed by multiple imputation under missing at random approach. LSM = least square mean.
From Baseline (Day 1) to the end of the Double-blind Period (Month 6)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant 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 IMP, whether or not related to the IMP. TEAEs are defined as all AEs started on or worsened in severity on or after the date of receiving first dose of IMP and before or on the end of study (EOS) date.
From Baseline to the end of the Double-blind Period (Month 6)
Percentage of Participants With Treatment-emergent Adverse Events for Romosozumab During Overall Period
An 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 use of a IMP, whether or not related to IMP. TEAEs are defined as all AEs started on or worsened in severity on or after date of receiving first dose of IMP and before or on EOS date except lipid-type AEs starting on date of first dose of IMP and not worsening (and not deemed IMP related by the investigator). As pre-specified in Protocol and SAP, TEAEs were assessed and reported for 6 months for participants in placebo/romosozumab arm (Open-label Period) and for a total of 12 months for participants in romosozumab/romosozumab arm (Double-blind Period + Open-label Period combined) + 3 months of Safety follow-up for both arms (Up to Month 15) during overall period.
From Month 7 up to Month 12 (Placebo/Romo) and From Day 1 up to Month 12 (Romo/Romo) + 3-month SFU (up to Month 15)
Secondary Outcomes (5)
Percent Change From Baseline in Bone Mineral Density at the Total Hip to the End of Double-Blind Period
From Baseline to the end of the Double-blind Period (Month 6)
Percent Change From Baseline in Bone Mineral Density at the Femoral Neck to the End of the Double-Blind Period
From Baseline to the end of the Double-blind Period (Month 6)
Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
Baseline, Month 12
Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12
Baseline, Month 12
Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12
Baseline, Month 12
Study Arms (2)
Romosozumab
EXPERIMENTALSubjects randomized to this arm will receive romosozumab during all treatment Periods.
Placebo
PLACEBO COMPARATORSubjects randomized to this arm will receive placebo during the Double-Blind-Placebo controlled Period and romosozumab during the Open-Label treatment Period
Interventions
Subjects will receive romosozumab in a specified sequence during the treatment Period.
Subjects will receive Placebo in a specified sequence during the treatment Period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
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
Beijing, China
Op0002 20021
Chengdu, China
Op0002 20133
Chengdu, China
Op0002 20137
Chengdu, China
Op0002 20205
Foshan, China
Op0002 20117
Guangzhou, China
Op0002 20124
Guangzhou, China
Op0002 20209
Nanchang, China
Op0002 20135
Nanjing, China
Op0002 20202
Pingxiang, China
Op0002 20199
Rui’an, China
Op0002 20116
Shanghai, China
Op0002 20118
Shanghai, China
Op0002 20121
Shanghai, China
Op0002 20123
Shanghai, China
Op0002 20129
Shanghai, China
Op0002 20119
Suzhou, China
Op0002 20204
Suzhou, China
Op0002 20122
Tianjin, China
Op0002 20136
Tianjin, China
Op0002 20120
Wuhan, China
Op0002 20134
Yueyang, China
Op0002 20132
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2021
First Posted
October 5, 2021
Study Start
October 21, 2021
Primary Completion
November 9, 2023
Study Completion
November 9, 2023
Last Updated
December 5, 2024
Results First Posted
December 5, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.