Trial Outcomes & Findings for A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis (NCT NCT04664959)
NCT ID: NCT04664959
Last Updated: 2025-02-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
457 participants
Primary outcome timeframe
Baseline and Month 12
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
SB16
Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6.
|
Prolia
Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6.
|
SB16+SB16
Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received SB16 in the Main period continued to receive SB16, but they also followed the randomisation procedure to maintain blinding.
|
Prolia+SB16
Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16).
|
Prolia+Prolia
Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16).
|
|---|---|---|---|---|---|
|
Main Period
STARTED
|
225
|
232
|
0
|
0
|
0
|
|
Main Period
COMPLETED
|
206
|
201
|
0
|
0
|
0
|
|
Main Period
NOT COMPLETED
|
19
|
31
|
0
|
0
|
0
|
|
Transition Period
STARTED
|
0
|
0
|
206
|
100
|
101
|
|
Transition Period
COMPLETED
|
0
|
0
|
206
|
99
|
99
|
|
Transition Period
NOT COMPLETED
|
0
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
Baseline characteristics by cohort
| Measure |
SB16
n=225 Participants
Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6.
|
Prolia
n=232 Participants
Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6.
|
Total
n=457 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
136 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 5.87 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 6.03 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 5.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
225 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
457 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
207 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
415 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Outcome measures
| Measure |
SB16
n=225 Participants
Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6.
|
Prolia
n=231 Participants
Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6.
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD at Month 12
|
5.63 %Change of BMD
Standard Error 0.250
|
5.30 %Change of BMD
Standard Error 0.254
|
Adverse Events
SB16
Serious events: 12 serious events
Other events: 116 other events
Deaths: 0 deaths
Prolia Overall
Serious events: 11 serious events
Other events: 107 other events
Deaths: 0 deaths
Prolia+SB16
Serious events: 5 serious events
Other events: 46 other events
Deaths: 0 deaths
Prolia+Prolia
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB16
n=225 participants at risk
Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received SB16 in the Main period continued to receive SB16, but they also followed the randomisation procedure to maintain blinding.
|
Prolia Overall
n=231 participants at risk
Prolia Overall include subjects who had randomised to Prolia at Month 0 and had re-randomisation (Prolia+SB16 or Prolia+Prolia) at Month 12. Prolia+SB16 and Prolia+Prolia may not add up to Prolia Overall.
|
Prolia+SB16
n=100 participants at risk
Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16).
|
Prolia+Prolia
n=101 participants at risk
Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16).
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.89%
2/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
1.0%
1/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Nervous system disorders
Intracranial aneurysm
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
1.0%
1/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
General disorders
General physical health deterioration
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.99%
1/101 • Overall Period (18 months)
|
|
Eye disorders
Cataract
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.99%
1/101 • Overall Period (18 months)
|
|
Eye disorders
Retinal detachment
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.99%
1/101 • Overall Period (18 months)
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
1.0%
1/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Renal and urinary disorders
Urethral caruncle
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
1.0%
1/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.44%
1/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
1.0%
1/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.99%
1/101 • Overall Period (18 months)
|
|
Infections and infestations
COVID-19
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Infections and infestations
Pneumonia
|
0.44%
1/225 • Overall Period (18 months)
|
0.00%
0/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.99%
1/101 • Overall Period (18 months)
|
|
Infections and infestations
Septic shock
|
0.00%
0/225 • Overall Period (18 months)
|
0.43%
1/231 • Overall Period (18 months)
|
0.00%
0/100 • Overall Period (18 months)
|
0.99%
1/101 • Overall Period (18 months)
|
Other adverse events
| Measure |
SB16
n=225 participants at risk
Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received SB16 in the Main period continued to receive SB16, but they also followed the randomisation procedure to maintain blinding.
|
Prolia Overall
n=231 participants at risk
Prolia Overall include subjects who had randomised to Prolia at Month 0 and had re-randomisation (Prolia+SB16 or Prolia+Prolia) at Month 12. Prolia+SB16 and Prolia+Prolia may not add up to Prolia Overall.
|
Prolia+SB16
n=100 participants at risk
Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16).
|
Prolia+Prolia
n=101 participants at risk
Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6. At Month 12, subjects who received Prolia in the Main period of the SB16-3001 study were randomised again in a 1:1 ratio to either continue on Prolia (Prolia+Prolia) or were transitioned to SB16 (Prolia+SB16).
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
7.6%
17/225 • Overall Period (18 months)
|
5.6%
13/231 • Overall Period (18 months)
|
8.0%
8/100 • Overall Period (18 months)
|
5.0%
5/101 • Overall Period (18 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
21/225 • Overall Period (18 months)
|
5.2%
12/231 • Overall Period (18 months)
|
7.0%
7/100 • Overall Period (18 months)
|
4.0%
4/101 • Overall Period (18 months)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.9%
11/225 • Overall Period (18 months)
|
4.8%
11/231 • Overall Period (18 months)
|
5.0%
5/100 • Overall Period (18 months)
|
5.9%
6/101 • Overall Period (18 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.8%
4/225 • Overall Period (18 months)
|
3.0%
7/231 • Overall Period (18 months)
|
6.0%
6/100 • Overall Period (18 months)
|
0.00%
0/101 • Overall Period (18 months)
|
|
Infections and infestations
COVID-19
|
8.9%
20/225 • Overall Period (18 months)
|
7.8%
18/231 • Overall Period (18 months)
|
5.0%
5/100 • Overall Period (18 months)
|
10.9%
11/101 • Overall Period (18 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
13/225 • Overall Period (18 months)
|
5.2%
12/231 • Overall Period (18 months)
|
3.0%
3/100 • Overall Period (18 months)
|
5.0%
5/101 • Overall Period (18 months)
|
|
Infections and infestations
Urinary tract infection
|
5.8%
13/225 • Overall Period (18 months)
|
3.0%
7/231 • Overall Period (18 months)
|
1.0%
1/100 • Overall Period (18 months)
|
5.0%
5/101 • Overall Period (18 months)
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
10/225 • Overall Period (18 months)
|
7.8%
18/231 • Overall Period (18 months)
|
7.0%
7/100 • Overall Period (18 months)
|
8.9%
9/101 • Overall Period (18 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.2%
23/225 • Overall Period (18 months)
|
11.7%
27/231 • Overall Period (18 months)
|
11.0%
11/100 • Overall Period (18 months)
|
12.9%
13/101 • Overall Period (18 months)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.1%
16/225 • Overall Period (18 months)
|
3.0%
7/231 • Overall Period (18 months)
|
2.0%
2/100 • Overall Period (18 months)
|
5.0%
5/101 • Overall Period (18 months)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
4.9%
11/225 • Overall Period (18 months)
|
3.9%
9/231 • Overall Period (18 months)
|
6.0%
6/100 • Overall Period (18 months)
|
3.0%
3/101 • Overall Period (18 months)
|
Additional Information
Director of Clinical Trials
Samsung Bioepis Co., Ltd
Phone: +82-32-728-0371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place