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    Clinical Trial Results:
    A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity between SB16 (proposed denosumab biosimilar) and Prolia® in Postmenopausal Women with Osteoporosis

    Summary
    EudraCT number
    		 2020-001479-34
    Trial protocol
    		 LT   DK   CZ  
    Global end of trial date
    03 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Nov 2024
    First version publication date
    13 Nov 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SB16-3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Samsung Bioepis Co., Ltd.
    Sponsor organisation address
    76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, Korea, Republic of, 21987
    Public contact
    Information Desk, Samsung Bioepis Co., Ltd., +82 327280114, bioepisinfo@samsung.com
    Scientific contact
    Information Desk, Samsung Bioepis Co., Ltd., +82 327280114, bioepisinfo@samsung.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the equivalence of SB16 to Prolia®, in terms of percent change from baseline in lumbar spine bone mineral density (BMD) at Month 12 in subjects with postmenopausal osteoporosis (PMO).
    Protection of trial subjects
    IPs were administered as a single subcutaneous injection in the upper arm, the upper thigh, or the abdomen. Only the Investigator or trained designee with an appropriate qualification (per local regulation) could perform and monitor the administration of IPs. In this study, IPs were administered only on an on-site basis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 262
    Country: Number of subjects enrolled
    Czechia: 118
    Country: Number of subjects enrolled
    Denmark: 11
    Country: Number of subjects enrolled
    Lithuania: 25
    Country: Number of subjects enrolled
    Korea, Republic of: 41
    Worldwide total number of subjects
    457
    EEA total number of subjects
    416
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    184
    From 65 to 84 years
    273
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at a total of 40 study centres: 9 centres in Czech Republic, 4 centres in Denmark, 4 centres in Lithuania, 13 centres in Poland, and 10 centres in Republic of Korea.

    Pre-assignment
    Screening details
    		 Subjects were randomised in a 1:1 ratio to receive either SB16 or Prolia subcutaneously at Months 0 and 6.

    Period 1
    Period 1 title
    Main period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SB16
    Arm description
    		 Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SB16
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Solution for injection
    Dosage and administration details
    60 mg every 6 months, Subcutaneous injection

    Arm title
    		 Prolia
    Arm description
    		 Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prolia
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    60 mg every 6 months, Subcutaneous injection

    Number of subjects in period 1
    		SB16 Prolia
    Started
    225
    232
    Completed
    206
    201
    Not completed
    19
    31
         Consent withdrawn by subject
    10
    19
         Physician decision
    1
    -
         Adverse event, non-fatal
    4
    8
         Other
    -
    1
         Lack of efficacy
    4
    1
         Protocol deviation
    -
    2
    Period 2
    Period 2 title
    Transition Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SB16+SB16
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SB16
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Solution for injection
    Dosage and administration details
    60 mg every 6 months, Subcutaneous injection

    Arm title
    		 Prolia+SB16
    Arm description
    		 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).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    SB16
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Solution for injection
    Dosage and administration details
    60 mg every 6 months, Subcutaneous injection

    Arm title
    		 Prolia+Prolia
    Arm description
    		 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).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prolia
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    60 mg every 6 months, Subcutaneous injection

    Number of subjects in period 2
    		SB16+SB16 Prolia+SB16 Prolia+Prolia
    Started
    206
    100
    101
    Completed
    206
    99
    99
    Not completed
    0
    1
    2
         Consent withdrawn by subject
    -
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SB16
    Reporting group description
    		 Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6.

    Reporting group title
    Prolia
    Reporting group description
    		 Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6.

    Reporting group values
    		 SB16 Prolia Total
    Number of subjects
    		 225 232 457
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 89 95 184
        From 65-84 years
    		 136 137 273
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.5 ( 5.87 ) 66.3 ( 6.03 ) -
    Gender categorical
    Units: Subjects
        Female
    		 225 232 457
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    SB16
    Reporting group description
    		 Subjects were randomly assigned to receive SB16 subcutaneously 60 mg at Months 0 and 6.

    Reporting group title
    Prolia
    Reporting group description
    		 Subjects were randomly assigned to receive Prolia subcutaneously 60 mg at Months 0 and 6.
    Reporting group title
    SB16+SB16
    Reporting group description
    		 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.

    Reporting group title
    Prolia+SB16
    Reporting group description
    		 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).

    Reporting group title
    Prolia+Prolia
    Reporting group description
    		 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).

    Primary: Percent Change from Baseline in Lumbar Spine BMD at Month 12

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    End point title
    		 Percent Change from Baseline in Lumbar Spine BMD at Month 12
    End point description
    End point type
    Primary
    End point timeframe
    At Month 12
    End point values
    		 SB16 Prolia
    Number of subjects analysed
    225
    231
    Units: Percent Change from Baseline
        least squares mean (standard error)
    5.63 ( 0.250 )
    5.30 ( 0.254 )
    Statistical analysis title
    		 Equivalence test
    Comparison groups
    SB16 v Prolia
    Number of subjects included in analysis
    456
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Least squares mean difference
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 1.03

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from the time of signing the written informed consent until the EOS/ET.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    SB16
    Reporting group description
    		 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.

    Reporting group title
    Prolia+SB16/Prolia+Prolia
    Reporting group description
    		 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).

    Reporting group title
    Prolia+SB16
    Reporting group description
    		 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).

    Reporting group title
    Prolia+Prolia
    Reporting group description
    		 -

    Serious adverse events
    		 SB16 Prolia+SB16/Prolia+Prolia Prolia+SB16 Prolia+Prolia
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 225 (5.33%)
    11 / 231 (4.76%)
    5 / 100 (5.00%)
    3 / 101 (2.97%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenal adenoma
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Forearm fracture
         subjects affected / exposed
    2 / 225 (0.89%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Intracranial aneurysm
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal infarction
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral caruncle
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 225 (0.44%)
    1 / 231 (0.43%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 225 (0.44%)
    0 / 231 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 225 (0.00%)
    1 / 231 (0.43%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SB16 Prolia+SB16/Prolia+Prolia Prolia+SB16 Prolia+Prolia
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 225 (51.56%)
    107 / 231 (46.32%)
    46 / 100 (46.00%)
    49 / 101 (48.51%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 225 (7.56%)
    13 / 231 (5.63%)
    8 / 100 (8.00%)
    5 / 101 (4.95%)
         occurrences all number
    21
    15
    9
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    21 / 225 (9.33%)
    12 / 231 (5.19%)
    7 / 100 (7.00%)
    4 / 101 (3.96%)
         occurrences all number
    24
    13
    8
    4
    Osteoarthritis
         subjects affected / exposed
    11 / 225 (4.89%)
    11 / 231 (4.76%)
    5 / 100 (5.00%)
    6 / 101 (5.94%)
         occurrences all number
    12
    13
    5
    8
    Musculoskeletal pain
         subjects affected / exposed
    4 / 225 (1.78%)
    7 / 231 (3.03%)
    6 / 100 (6.00%)
    0 / 101 (0.00%)
         occurrences all number
    4
    7
    6
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    20 / 225 (8.89%)
    18 / 231 (7.79%)
    5 / 100 (5.00%)
    11 / 101 (10.89%)
         occurrences all number
    20
    18
    5
    11
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 225 (5.78%)
    12 / 231 (5.19%)
    3 / 100 (3.00%)
    5 / 101 (4.95%)
         occurrences all number
    17
    12
    3
    5
    Urinary tract infection
         subjects affected / exposed
    13 / 225 (5.78%)
    7 / 231 (3.03%)
    1 / 100 (1.00%)
    5 / 101 (4.95%)
         occurrences all number
    16
    7
    1
    5
    Nasopharyngitis
         subjects affected / exposed
    10 / 225 (4.44%)
    18 / 231 (7.79%)
    7 / 100 (7.00%)
    9 / 101 (8.91%)
         occurrences all number
    11
    19
    8
    9
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    23 / 225 (10.22%)
    27 / 231 (11.69%)
    11 / 100 (11.00%)
    13 / 101 (12.87%)
         occurrences all number
    26
    29
    12
    14
    Hypercholesterolaemia
         subjects affected / exposed
    16 / 225 (7.11%)
    7 / 231 (3.03%)
    2 / 100 (2.00%)
    5 / 101 (4.95%)
         occurrences all number
    16
    7
    2
    5
    Vitamin D deficiency
         subjects affected / exposed
    11 / 225 (4.89%)
    9 / 231 (3.90%)
    6 / 100 (6.00%)
    3 / 101 (2.97%)
         occurrences all number
    11
    9
    6
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 May 2021
    This amendment considered clarifications on: •To add secondary objective considering percentage change from baseline in lumbar spine BMD at Month 6 •To add AUEC0-M6 of serum CTX as a secondary endpoint •To add the additional information for missing data imputation

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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