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    Clinical Trial Results:
    Improving the outcome for elderly patients after osteoporotic femoral fractures

    Summary
    EudraCT number
    		 2009-015058-38
    Trial protocol
    		 GB  
    Global end of trial date
    05 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Mar 2020
    First version publication date
    20 Mar 2020
    Other versions
    Summary report(s)
    		 OFF trial Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    OR09/9018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Leeds
    Sponsor organisation address
    Worsley Building, Leeds, United Kingdom, LS2 9JT
    Public contact
    Professor P.V. Giannoudis, University of Leeds, 0113 2067068, P.Giannoudis@leeds.ac.uk
    Scientific contact
    Professor P.V. Giannoudis, University of Leeds, 0113 2067068, P.Giannoudis@leeds.ac.uk
    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
    05 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To produce preliminary evidence testing the hypothesis that it is possible to accelerate the healing of trochanteric and distal femoral fractures with the administration of therapeutic agents (Parathyroid Hormone, Biphosphonate, Vitamin D and Calcium) and thus reduce pain and functional impairment at 3 and 6months.
    Protection of trial subjects
    The trial was conducted in accordance with GCP and the EU clinical trials regulation, was carried out under a Clinical Trial Authorisation, and the Local REC approved the study. The trial was also independently monitored by the Sponsor.To comply with regulations, all essential source and study documentation will be securely retained for at least 15 years.
    Background therapy
    		 Osteoporosis is a common disease in the elderly and the fractures that result from this disorder affect 40% of women and 14 % of men over the age of 50 years.1 Osteoporosis is characterised by loss of trabecular bone mass and connectivity, as well as thinning of cortical bone.2 Low bone mineral density in the elderly can result from either low peak bone mass, or accelerated bone loss, or a combination of the two. A strong genetic component has also been suggested to contribute to the pathogenesis of osteoporotic fractures.3, 4, 5 With the increasing number of elderly people it is anticipated that this disease process will become an epidemic in the years to come. Indeed, statistics predict that by the year 2012, 25% of the European Population will be over the age of 65 and by year 2020 over 52 million will be over 65 years old in the USA.6 In the UK in particular, according to the 2001 census, elderly over 60 years of age outnumbered the under 16 years old for the first time and elderly over 85 increased 5 fold since 1951. The elderly patient therefore will increasingly consume more hospital resources than patients from any other group especially for the treatment of fractures of both the upper and lower extremity as a result of bone fragility.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Apr 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    0
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A 1-year recruitment period will be allowed. Each patient will be recruited and have to start treatment within one week from surgery.Patients will be recruited at Leeds. This tertiary referral trauma centre admits over 500 hip fractures each yea rand therefore, has a large clinical base to participate in this study.

    Pre-assignment
    Screening details
    		 Patients with a broken Femur caused by Osteoporosis were identified in Clinic, and provided with a copy of the PIS. It was made clear to participants could withdraw at any time.

    Period 1
    Period 1 title
    Main Trial Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment A: Anti-resorptive agent - Biphosphonates
    Arm description
    		 Treatment A: Anti-resorptive agent - Biphosphonates (Alendronate) Fosamax 70 mg tablets (Merck)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fosamax 70mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    70mg to be taken, two tablets daily

    Arm title
    		 Anabolic agent - Parathyroid hormone
    Arm description
    		 Patients will receive 20 micrograms of teriparatide (Forsteo) given daily by subcutaneous injection for 4 weeks. This will be supplemented by administration of Vitamin D (800 iu/daily) and Calcium (1.200 mg/daily of elemental calcium) for the same time period, which will be preferably the tablets will be taken once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    teriparatide (Forsteo)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients will receive 20 micrograms of teriparatide (Forsteo) given daily by subcutaneous injection for 4 weeks. This will be supplemented by administration of Vitamin D (800 iu/daily) and Calcium (1.200 mg/daily of elemental calcium) for the same time period,which will be preferably the tablets will be taken once daily.

    Arm title
    		 Control - Vitamin D and Calcium
    Arm description
    		 Patients will receive Vitamin D (800 iu/daily) and Calcium (1.200 mg/daily of elemental calcium) in two tablets daily for 4 weeks. Preferably the tablets will be taken once daily.
    Arm type
    		 Control

    Investigational medicinal product name
    Vitamin D and Calcium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will receive Vitamin D (800 iu/daily) and Calcium (1.200 mg/daily of elemental calcium) in two tablets daily for 4 weeks. Preferably the tablets will be taken once daily.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The data analysts were blinded to the identity of the treatment from the time of randomisation. The Department of Clinical Trials of our local pharmacy (Leeds General Infirmary) was responsible for supplying, packaging and labelling the investigational and control drugs, as well as for the randomisation of the recruited patients to the different study groups.
    Number of subjects in period 1
    		Treatment A: Anti-resorptive agent - Biphosphonates Anabolic agent - Parathyroid hormone Control - Vitamin D and Calcium
    Started
    11
    9
    10
    Completed
    8
    6
    5
    Not completed
    3
    3
    5
         Consent withdrawn by subject
    3
    3
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Trial Period
    Reporting group description
    		 -

    Reporting group values
    		 Main Trial Period Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 75 ( 8.89 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    Treatment A: Anti-resorptive agent - Biphosphonates
    Reporting group description
    		 Treatment A: Anti-resorptive agent - Biphosphonates (Alendronate) Fosamax 70 mg tablets (Merck)

    Reporting group title
    Anabolic agent - Parathyroid hormone
    Reporting group description
    		 Patients will receive 20 micrograms of teriparatide (Forsteo) given daily by subcutaneous injection for 4 weeks. This will be supplemented by administration of Vitamin D (800 iu/daily) and Calcium (1.200 mg/daily of elemental calcium) for the same time period, which will be preferably the tablets will be taken once daily.

    Reporting group title
    Control - Vitamin D and Calcium
    Reporting group description
    		 Patients will receive Vitamin D (800 iu/daily) and Calcium (1.200 mg/daily of elemental calcium) in two tablets daily for 4 weeks. Preferably the tablets will be taken once daily.

    Primary: Pain Reduction and functional impairment at 3-6 months Post operative

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    End point title
    		 Pain Reduction and functional impairment at 3-6 months Post operative [1]
    End point description
    End point type
    Primary
    End point timeframe
    3-6 months Post operative.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No meaningful statistical comparative analysis was possible due to the small sample that was possible to enrol and follow up, as this pilot randomized clinical trial was closed due to limited recruitment rates and funding resources.
    End point values
    		 Treatment A: Anti-resorptive agent - Biphosphonates Anabolic agent - Parathyroid hormone Control - Vitamin D and Calcium
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: yes/no
    Notes
    [2] - No meaningful statistical comparative analysis was possible due to the small sample
    [3] - No meaningful statistical comparative analysis was possible due to the small sample
    [4] - No meaningful statistical comparative analysis was possible due to the small sample
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All AEs will be recorded on the appropriate CRF with the following information: 1. the severity grade (mild, moderate, severe) 2. its relationship to the study drug(s) (suspected/not suspected) 3. whether it constitutes a serious adverse event (SAE)
    Adverse event reporting additional description
    All SAEs will be reported by the Principal Investigator (PI) or Trial Coordinator within 24 hours of being made aware of the event. The PI will record the event with an assessment of seriousness, causality, expectedness and severity on an SAE form. The PI will also ensure that follow-up information is provided when available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Treatment A: Anti-resorptive agent - Biphosphonates
    Reporting group description
    		 Treatment A: Anti-resorptive agent - Biphosphonates (Alendronate) Fosamax 70 mg tablets (Merck)

    Reporting group title
    Anabolic agent - Parathyroid hormone
    Reporting group description
    		 Patients will receive 20 micrograms of teriparatide (Forsteo) given daily by subcutaneous injection for 4 weeks. This will be supplemented by administration of Vitamin D (800 iu/daily) and Calcium (1.200 mg/daily of elemental calcium) for the same time period, which will be preferably the tablets will be taken once daily.

    Reporting group title
    Control - Vitamin D and Calcium
    Reporting group description
    		 Patients will receive Vitamin D (800 iu/daily) and Calcium (1.200 mg/daily of elemental calcium) in two tablets daily for 4 weeks. Preferably the tablets will be taken once daily.

    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: Details of adverse events can be found in table 1 of the attached summary paper, in the 'complications' row.
    Serious adverse events
    		 Treatment A: Anti-resorptive agent - Biphosphonates Anabolic agent - Parathyroid hormone Control - Vitamin D and Calcium
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    1
    0
    3
         number of deaths resulting from adverse events
    0
    0
    0
    Product issues
    Implant Failure
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment A: Anti-resorptive agent - Biphosphonates Anabolic agent - Parathyroid hormone Control - Vitamin D and Calcium
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Sep 2010
    MHRA required the clearer description of one of the exclusion criteria (regarding women of child bear age, and patients with malignancies), the revision of the dosing schemes for Calcium tablets (correction of the mgs of calcium and vitamin D to be administered - still each patient will receive 2 tablets per day as initially described), clarifications on the time endpoints of the study which now are all related to the time from surgery (T0).
    12 Sep 2011
    Amendments made to the protocol and PIS as a result of monitoring findings. PIS amended to match dosing strategy to the labels generated by the trial pharmacy department. Protocol amended to v6.0, PIS to v4.0

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Sep 2012
    Study was suspended for patient recruitment as a result of the findings uncovered as part of a Sponsor monitoring visit in September 2012. Study was monitored previously in June 2011, and the findings from the previous monitoring visit were not implemented appropriately. Study was restarted once the Sponsor determined all monitoring actions had been resolved.
    26 Nov 2012

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Trial did not collect enough data to report on the primary endpoint of the study.
    For support, Contact us.
    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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