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    Clinical Trial Results:
    Postoperative treatment with parathyroidea hormone Forteo® in patients undergoing posterolateral spinal fusion surgery. A prospektive and a randomized double-blinded, placebo-controlled study

    Summary
    EudraCT number
    		 2011-006152-36
    Trial protocol
    		 DK  
    Global end of trial date
    13 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Feb 2021
    First version publication date
    27 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1774
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00615236
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rygcenter Syddanmark
    Sponsor organisation address
    Oestre Hougvej 55, Middelfart, Denmark, 5500
    Public contact
    Mikkel Andersen, Rygkirurgisk forskningsenhed, SLB, 0045 63484198, mikkel@dadlnet.dk
    Scientific contact
    Mikkel Andersen, Rygkirurgisk forskningsenhed, SLB, 0045 63484198, mikkel@dadlnet.dk
    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
    13 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary aim of this study is to examine the effect on clinical outcome of postoperative treatment with Forteo® by evaluating self reported disability,(ADL functions-data) in elderly patients undergoing spinal stabilization surgery compared with placebotreatment.
    Protection of trial subjects
    While the patients were hospitalized, a research nurse instructed the patients in proper injection techniques and self-administration of 20 μg teriparatide, PTH or placebo (identical pen injection devices with saline) during the three months (90 days) postoperative period. Both patient groups received supplemental calcium and vitamin D supplements and were monitored during the treatment period for any complications or side effects by the operating surgeon. Additional control blood samples, at discharge (4-5 days postoperatively) and at follow-ups were monitored by a spine surgeon at the department, David Krum Møller (DKM) and an endocrinologist at Odense University Hospital, Pernille Hermann (PH). Serum calcium, in particular, was closely monitored, because of the risk of hypercalcemia after teriparatide treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2012
    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
    Denmark: 101
    Worldwide total number of subjects
    101
    EEA total number of subjects
    101
    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)
    7
    From 65 to 84 years
    91
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 The referral criteria for the unit comprise leg pain, an episode of walking limitation with a duration of three to 12 months and insufficient effect of conservative treatment

    Pre-assignment
    Screening details
    		 Eligible patients were identified through consecutive screening of clinic schedules of ambulatory visits.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Data analyst, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 pen injection devices with saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Percutaneous use
    Dosage and administration details
    1 ml

    Arm title
    		 Intervention
    Arm description
    		 recombinant human parathyroid hormone [PTH] [1-34]
    Arm type
    		 Experimental

    Investigational medicinal product name
    recombinant human parathyroid hormone [PTH] [1-34]
    Investigational medicinal product code
    Other name
    Forteo®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    20 μg teriparatide, PTH

    Number of subjects in period 1
    		Placebo Intervention
    Started
    51
    50
    Completed
    46
    41
    Not completed
    5
    9
         Physician decision
    5
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 pen injection devices with saline

    Reporting group title
    Intervention
    Reporting group description
    		 recombinant human parathyroid hormone [PTH] [1-34]

    Reporting group values
    		 Placebo Intervention Total
    Number of subjects
    		 51 50 101
    Age categorical
    Units: Subjects
    Age continuous
    mean age 71 years (SD 1,01)
    Units: years
        arithmetic mean (standard deviation)
    		 70 ± 0.88 71 ± 1.01 -
    Gender categorical
    Units: Subjects
        Female
    		 44 39 83
        Male
    		 7 11 18

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 pen injection devices with saline

    Reporting group title
    Intervention
    Reporting group description
    		 recombinant human parathyroid hormone [PTH] [1-34]

    Primary: 12 months post-operatively, compared to placebo

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    End point title
    		 12 months post-operatively, compared to placebo
    End point description
    End point type
    Primary
    End point timeframe
    One year post operative
    End point values
    		 Placebo Intervention
    Number of subjects analysed
    46
    41
    Units: ODI
        arithmetic mean (standard deviation)
    39.24 ± 12.59
    36.24 ± 12.61
    Statistical analysis title
    		 Stats
    Statistical analysis description
    Descriptive statistics, including mean (standard deviation (SD)) or median (interquartile range (IQR)), for continuous variables. All analyses were conducted with STATA 15 (StataCorp, 2000, College Station, TX: Stata Corporation, USA).
    Comparison groups
    Placebo v Intervention
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    One Year postoperative
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    PTH Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Group
    Reporting group description
    		 -

    Serious adverse events
    		 PTH Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PTH Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Very small sample size with only 41 patients completing the trail in the intervention group

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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