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OsteoporosisPhase 3NCT05067335

A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis

A Phase 3 study testing Romosozumab in people with Osteoporosis, run by UCB Biopharma SRL at 30 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 90 years, women only
Conditions the study is for
Osteoporosis
What is being tested?
Romosozumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
327 participants
Where
30 sitesChina
Study dates
21 Oct 2021to 9 Nov 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 38Show fewer
  • 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 %)

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites

  • Op0002 20040

    Beijing

  • Op0002 20115

    Beijing

  • Op0002 20125

    Beijing

  • Op0002 20127

    Beijing

  • Op0002 20128

    Beijing

  • Op0002 20130

    Beijing

  • Op0002 20131

    Beijing

  • Op0002 20157

    Beijing

  • Op0002 20021

    Chengdu

  • Op0002 20133

    Chengdu

  • Op0002 20137

    Chengdu

  • Op0002 20205

    Foshan

  • Op0002 20117

    Guangzhou

  • Op0002 20124

    Guangzhou

  • Op0002 20209

    Nanchang

  • Op0002 20135

    Nanjing

  • Op0002 20202

    Pingxiang

  • Op0002 20199

    Rui’an

  • Op0002 20116

    Shanghai

  • Op0002 20118

    Shanghai

  • Op0002 20121

    Shanghai

  • Op0002 20123

    Shanghai

  • Op0002 20129

    Shanghai

  • Op0002 20119

    Suzhou

  • Op0002 20204

    Suzhou

  • Op0002 20122

    Tianjin

  • Op0002 20136

    Tianjin

  • Op0002 20120

    Wuhan

  • Op0002 20134

    Yueyang

  • Op0002 20132

    Zhengzhou

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis

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.

Conditions
Osteoporosis
Being tested
Romosozumab, Placebo
Keywords
Osteoporosis, Phase 3, Chinese Patients, Romosozumab
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RomosozumabDrug

    Subjects will receive romosozumab in a specified sequence during the treatment Period.

  • PlaceboDrug

    Subjects will receive Placebo in a specified sequence during the treatment Period.

Study groups in NCT05067335
Study groupRoleWhat they receive
RomosozumabExperimentalSubjects randomized to this arm will receive romosozumab during all treatment Periods.
Receives: Drug: Romosozumab
PlaceboPlacebo comparatorSubjects randomized to this arm will receive placebo during the Double-Blind-Placebo controlled Period and romosozumab during the Open-Label treatment Period
Receives: Drug: Romosozumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Baseline (Day 1) to the end of the Double-blind Period (Month 6)

  2. 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.

    Measured: From Baseline to the end of the Double-blind Period (Month 6)

  3. 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.

    Measured: 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)

  1. Percent Change From Baseline in Bone Mineral Density at the Total Hip to the End of Double-Blind Period

    Percent change from baseline in BMD at the total hip was assessed by DXA at 6 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the 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.

    Measured: From Baseline to the end of the Double-blind Period (Month 6)

  2. Percent Change From Baseline in Bone Mineral Density at the Femoral Neck to the End of the Double-Blind Period

    Percent change from baseline in BMD at the femoral neck was assessed by DXA at 6 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the 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.

    Measured: From Baseline to the end of the Double-blind Period (Month 6)

  3. Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12

    Percent change from Baseline in BMD at the lumbar spine was assessed by DXA at 12 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the 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. For Placebo/Romosozumab Treatment group, only the post Month 6 value was used for imputation for Open-label Period, the values in the Double-blind Period were not carried forward into the Open-label Period.

    Measured: Baseline, Month 12

  4. Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12

    Percent change from Baseline in BMD at the total hip was assessed by DXA at 12 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the 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. For Placebo/Romosozumab Treatment group, only the post Month 6 value was used for imputation for Open-label Period, the values in the Double-blind Period were not carried forward into the Open-label Period.

    Measured: Baseline, Month 12

  5. Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12

    Percent change from Baseline in BMD at the femoral neck was assessed by DXA at 12 months. Missing postbaseline BMD other than due to COVID-19 were imputed using the 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. For Placebo/Romosozumab Treatment group, only the post Month 6 value was used for imputation for Open-label Period, the values in the Double-blind Period were not carried forward into the Open-label Period.

    Measured: Baseline, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2021
  2. Study start21 Oct 2021
  3. Primary completion9 Nov 2023
  4. Study completion9 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05067335
Sponsor's protocol ID
OP0002
Status last verified
Aug 2026
First submitted
23 Sep 2021
Last updated
28 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Zhenlin Z, Qingyun X, Decai C, Aijun C, Yanan H, Mei Z, Xu C, Hua L, Youjia X, Qun C, Huilin Y, Xiaoyan X, Yujie L, Xuan D, Jun J, LingLing G, Theresa RJ, Lars B, Weibo X. Romosozumab increases bone mineral density in postmenopausal Chinese women with osteoporosis: A randomised phase three study. J Orthop Translat. 2026 Jun 3;59:101135. doi: 10.1016/j.jot.2026.101135. eCollection 2026 Jul.

    PubMed 42282279

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Romosozumab in people with Osteoporosis, run by UCB Biopharma SRL at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine to the End of Double-Blind Period (time frame: From Baseline (Day 1) to the end of the Double-blind Period (Month 6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05067335, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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