A phase III clinical study to compare SB16 and Prolia® in postmenopausal women with osteoporosis.
- Conditions
- Postmenopausal osteoporosisMedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
- Registration Number
- EUCTR2020-001479-34-CZ
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 432
Subjects must meet all of the following criteria to be eligible for the study:
1.Postmenopausal women (defined as lack of menstrual period for at least 12 months prior to Screening, for which there is no other pathological or physiological cause) who are 55 to 80 years of age at Screening
Serum follicle stimulating hormone (FSH) test can be done at Screening in case of uncertainty.
2.Ambulatory and visually unimpaired to participate in the study at Screening, in the opinion of the Investigator
3.Absolute BMD consistent with T-score at the total hip or lumbar spine of = ?4 and = ?2.5, determined by central imaging centre at Screening
4.At least three evaluable vertebrae within L1 to L4, one evaluable femoral neck, and one evaluable hip joint for BMD measurement, determined by central imaging centre at Screening
5.Biologic (defined as any therapeutic monoclonal antibody or fusion receptor protein, including denosumab, denosumab biosimilars, or romosozumab) naïve at Screening
6.Body weight of = 50 kg and = 90 kg at Screening
7.Has provided informed consent voluntarily and must be able to, in the opinion of the Investigator, understand the implications of taking part in the study, be willing to follow the study requirements, and complete the study
Subjects must meet the following criteria to be enrolled in the Transition period:
1.Have been enrolled and completed the scheduled Month 12 of the Main period of the SB16-3001 study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 346
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86
Subjects meeting any of the following criteria are not eligible for the study:
1.One severe or more than two moderate vertebral fractures on spinal X-ray according to Genant classification, determined by central imaging centre at Screening
2.History of hip fracture or bilateral hip replacement at Screening
3.Uncorrected vitamin D deficiency
4.Hypercalcemia or hypocalcaemia at Screening
5.Inadequate haematological function at Screening
6.Inadequate renal or hepatic function at Screening
7.Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the investigational product (IP), including latex allergy or hereditary problems of fructose intolerance at Screening
8.May not tolerate long-term calcium or vitamin D supplementation or subject with malabsorption of calcium or vitamin D supplements, in the opinion of the Investigator, at Screening
9.Use of any of the medications that can affect BMD
10.Use of any non-biologic IP that is not indicated for osteoporosis from another study or use of an investigational device at Screening
11.Non-osteoporosis medical conditions that can affect BMD at Screening
23.Any clinically significant disease or disorder or laboratory abnormality which, in the opinion of the Investigator, would prevent the subject from completing the study or the interpretation of the study results at Screening and Randomisation
Subjects meeting the following criteria must not be enrolled in the Transition period:
1.Found to be of increased risk to continue enrolment, in the opinion of the Investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method