Postmenopausal Osteoporosis
Conditions
Brief summary
This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.
Detailed description
Subjects will be randomised in a 1:1 ratio to receive either SB16 or Prolia®. At Month 12, subjects in Prolia® treatment group will be randomised again in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. Investigational product (60 mg in 1 mL of SB16 or Prolia®) will be given subcutaneously every 6 months up to Month 12, and the last assessment will be done at Month 18.
Interventions
DRUGSB16 (Proposed Denosumab Biosimilar)
Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months. At Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously.
DRUGProlia® (Denosumab)
Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women who are 55 to 80 years of age at Screening * Ambulatory and visually unimpaired to participate in the study at Screening, in the opinion of the Investigator * Absolute BMD consistent with T-score at the total hip or lumbar spine of -4 and -2.5 at Screening * At least three evaluable vertebrae within L1 to L4, one evaluable femoral neck, and one evaluable hip joint for BMD measurement at Screening * Biologic naïve at Screening * Body weight of 50 kg and 90 kg at Screening
Exclusion criteria
* One severe or more than two moderate vertebral fractures on spinal X-ray according to Genant classification at Screening * History of hip fracture or bilateral hip replacement at Screening * Uncorrected vitamin D deficiency at Screening * Hypercalcemia or hypocalcaemia at Screening * Inadequate haematological function at Screening * Inadequate renal or hepatic function at Screening * Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the IP, including latex allergy or hereditary problems of fructose intolerance at Screening * 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 * Use of any of the medications that can affect BMD * Use of any non-biologic IP that is not indicated for osteoporosis from another study or use of an investigational device at Screening * Non-osteoporosis medical conditions that can affect BMD at Screening * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Baseline and Month 12 |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SB16 Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6. | 225 |
| Prolia Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. | 232 |
| Total | 457 |
Baseline characteristics
| Characteristic | SB16 | Prolia | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 136 Participants | 137 Participants | 273 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 95 Participants | 184 Participants |
| Age, Continuous | 66.5 years STANDARD_DEVIATION 5.87 | 66.3 years STANDARD_DEVIATION 6.03 | 66.4 years STANDARD_DEVIATION 5.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 23 Participants | 41 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 207 Participants | 208 Participants | 415 Participants |
| Sex: Female, Male Female | 225 Participants | 232 Participants | 457 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 225 | 0 / 231 | 0 / 100 | 0 / 101 |
| other Total, other adverse events | 116 / 225 | 107 / 231 | 46 / 100 | 49 / 101 |
| serious Total, serious adverse events | 12 / 225 | 11 / 231 | 5 / 100 | 3 / 101 |
Outcome results
Primary
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Time frame: Baseline and Month 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SB16 | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | 5.63 %Change of BMD | Standard Error 0.25 |
| Prolia | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | 5.30 %Change of BMD | Standard Error 0.254 |