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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05067335
Recruitment Status : Active, not recruiting
First Posted : October 5, 2021
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Romosozumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 21, 2021
Estimated Primary Completion Date : December 5, 2023
Estimated Study Completion Date : December 5, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Romosozumab

Arm Intervention/treatment
Experimental: Romosozumab
Subjects randomized to this arm will receive romosozumab during all treatment Periods.
Drug: Romosozumab
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
Drug: Romosozumab
Subjects will receive romosozumab in a specified sequence during the treatment Period.

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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:

    1. 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
    2. 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
    3. 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
    4. 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 %)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05067335


Locations
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Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT05067335    
Other Study ID Numbers: OP0002
First Posted: October 5, 2021    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Osteoporosis
Phase 3
Chinese Patients
Romosozumab
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases