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    Clinical Trial Results:
    ALOSTRA Alendronate treatment of osteoporosis in rheumatoid arthritis – indication and duration. A randomized, doubleblind, placebocontrolled multi-centre study to evaluate the effects of discontinuation of alendronate in patients with both rheumatoid arthritis and low bone mass.

    Summary
    EudraCT number
    		 2015-003638-28
    Trial protocol
    		 DK  
    Global end of trial date
    20 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Apr 2026
    First version publication date
    12 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2015/576
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02944799
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul Jensens Boulevard 99, Aarhus N, Denmark,
    Public contact
    Reumatologisk Forskning, Aarhus University Hospital, annebnie@rm.dk
    Scientific contact
    Reumatologisk Forskning, Aarhus University Hospital, annebnie@rm.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
    04 Apr 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of discontinuation of alendronate on bone metabolism in patients with non-glucocorticoid treated rheumatoid arthritis and alendronate-treated osteoporosis with a current T-score in the range of osteopenia. - to assess the effect of discontinuation of ALN on C-terminal telopeptide crosslinks (CTX) and Type 1 procollagen amino-terminal-propeptide (P1NP) after 6 months - to assess the effect of discontinuation of ALN on BMD at 2 years
    Protection of trial subjects
    All routine biochemical markers (visit 1-5) were analyzed and evaluated promptly. An increase in bone-specific alkaline phosphatase of more than 100% lead to the participant being called in for an extra visit for further evaluation of the cause. The patient was withdrawn from the study if there is suspicion of accelerated bone loss. All fractures were recorded and in the case of low-energy fracture the patient was withdrawn from the study. The 12 month DXA scans was reviewed and a BMD decrease of more than 5% lead to exclusion from the study. Adverse events of special interest included all fractures, and diseases of th eupper gastrointestinal tract. All patient-reported adverse events were recorded in a special file in the CRF and the electronic patient record (source data) and evaluated by a study investigator. Investigators immediately reported all SAEs to sponsor. Investigator then provided a detailed report in writing and the study participant in concern was identified with a personal number. Annual reports of all possible adverse events were reported to the Danish Health and Medicines Authority (Sundhedsstyrelsen) in the form of a Development Safety Update Report (DSUR). Any suspected unsuspected serious adverse events (SUSAR’s) were immediately reported by the investigators to Sponsor Ellen-Margrethe Hauge. Sponsor was responsible for reporting all SUSAR’s that are life-threatening or result in death to the Danish Health and Medicines Authority (Sundhedsstyrelsen) within 7 days. Within 8 days sponsor reported all relevant information regarding follow-up on the SUSAR. All other SUSARs were reported to the Danish Health and Medicines Authority (Sundhedsstyrelsen) and National Ethics Committee within 15 calendar days by sponsor. All reports of SUSARs included comments on consequences for the trial, if any.
    Background therapy
    		 Patients included in this trial will be treated according to the national Danish guidelines for treatment of RA. In the case of joint swelling the patient were offered a joint injection with GC in the form of triamcinolonacetonid , 40 mg/ml. If more than one swollen joint, a maximum of four joints was injected, or a maximum of 4 ml. Calcium and vitamin D supplement was prescribed in the form of an over-the-counter combination pill (Unikalk Forte) taken twice a day. Each pill contains 100mg calciumcarbonate, equivalent to 400mg calcium, and 19μgcholecalciferol, equivalent to 760 international units of vitamin D (IU).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2015
    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
    Denmark: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    20
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 November 2015 - december 2019. Denmark.

    Pre-assignment
    Screening details
    		 Participants with RA and low bone mass were recruited both directly from the rheumatology outpatient clinics, as well as by way of an information letter, which was sent to a population of 5000 potential participants who were registered in the National Patient Registry as having RA as well as osteoporosis or osteopenia, but no previous fractures.

    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
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All patients and investigators were blinded to treatment assignment. The allocation sequence was concealed from the researchers enrolling and assessing participants: The pharmacy provided placebo and ALN tablets in identical grey gelatinous coating in identical packages. Individual non-translucent envelopes marked with each randomization number were provided to each trial site to ensure possibility of individual un-blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Withdrawal
    Arm description
    		 Participants randomized to discontinuation of alendronate treatment. Participants instead received placebo tablets.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo tablets
    Pharmaceutical forms
    Capsule, soft + tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet each week, consisting of: Lactose mono hydrat: 85 mg, Potato starch: 86 mg, Gelatin: 3 mg, Magnesium stearate: 0,9 mg,Tale: 8,1 mg. All specified Ph.Eur, Class C

    Arm title
    		 Alendronate
    Arm description
    		 Continued treatment with alendronate 70 mg weekly
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Alendronate Sodium Monohydrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft + tablet
    Routes of administration
    Oral use
    Dosage and administration details
    alendronate 70 mg tabelt orally once weekly

    Number of subjects in period 1
    		Withdrawal Alendronate
    Started
    23
    27
    6 months assessment
    22
    24
    Completed
    14
    16
    Not completed
    9
    11
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    8
    7
         other safety concerns
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Withdrawal
    Reporting group description
    		 Participants randomized to discontinuation of alendronate treatment. Participants instead received placebo tablets.

    Reporting group title
    Alendronate
    Reporting group description
    		 Continued treatment with alendronate 70 mg weekly

    Reporting group values
    		 Withdrawal Alendronate Total
    Number of subjects
    		 23 27 50
    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)
    		 65.1 ( 7.3 ) 69.9 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 21 39
        Male
    		 5 6 11
    Post-menopausal women
    Number and percentage of participating women who reported as post-menopausal
    Units: Subjects
        yes
    		 18 21 39
        no
    		 0 0 0
        men
    		 5 6 11
    Previous fragility fractures
    Units: Subjects
        yes
    		 1 3 4
        no
    		 22 24 46
    Family history of osteoporosis
    Units: Subjects
        yes
    		 9 11 20
        no
    		 14 16 30
    Alcohol, >7 per week
    Units: Subjects
        yes
    		 1 11 12
        no
    		 22 16 38
    Current smoker
    Units: Subjects
        Yes
    		 7 4 11
        no
    		 16 23 39
    Treatment with bDMARDs
    Units: Subjects
        yes
    		 11 14 25
        no
    		 12 13 25
    Previous GC treatment
    Units: Subjects
        yes
    		 9 16 25
        no
    		 14 11 25
    ACPA positive
    Units: Subjects
        yes
    		 17 18 35
        no
    		 6 9 15
    RF positive
    Units: Subjects
        yes
    		 18 16 34
        no
    		 5 11 16
    Erosive disease
    Units: Subjects
        yes
    		 18 21 39
        no
    		 5 6 11
    DAS28CRP <2.6
    Units: Subjects
        yes
    		 15 18 33
        no
    		 8 9 17
    BMI
    Units: kg/cm2
        arithmetic mean (standard deviation)
    		 24.3 ( 3.6 ) 24.4 ( 3.9 ) -
    Years since menopause
    Units: Years
        arithmetic mean (standard deviation)
    		 16.3 ( 7.9 ) 23.4 ( 11.6 ) -
    RA disease duration
    Units: Years
        median (inter-quartile range (Q1-Q3))
    		 14 (10 to 21) 13.5 (6 to 25) -
    Years of alendronate treatment
    Units: Years
        median (inter-quartile range (Q1-Q3))
    		 7 (6 to 10) 6 (5 to 9) -
    DAS28CRP (score 2-10)
    Units: arbitrary
        arithmetic mean (standard deviation)
    		 2.3 ( 0.9 ) 2.2 ( 0.9 ) -
    HAQ (score 0-3)
    Units: arbitrary
        median (inter-quartile range (Q1-Q3))
    		 0.5 (0.1 to 1.1) 0.6 (0.0 to 1.3) -
    Number of tender joints (0-40)
    Units: arbitrary
        median (inter-quartile range (Q1-Q3))
    		 0.0 (0.0 to 3.0) 0.5 (0.0 to 2.0) -
    Number of swollen joints (0-40)
    Units: arbitrary
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 0) 0 (0 to 0) -
    CRP
    Units: µg/L
        median (inter-quartile range (Q1-Q3))
    		 4.0 (1.4 to 6.8) 2.0 (1.0 to 4.0) -
    BMD total hip
    Units: g/cm2
        arithmetic mean (standard deviation)
    		 0.762 ( 0.081 ) 0.747 ( 0.094 ) -
    BMD lumbar spine
    Units: g/cm2
        arithmetic mean (standard deviation)
    		 0.827 ( 0.100 ) 0.847 ( 0.101 ) -
    CTX
    Units: µg/L
        median (inter-quartile range (Q1-Q3))
    		 0.22 (0.17 to 0.27) 0.20 (0.17 to 0.23) -
    P1NP
    Units: µg/L
        median (inter-quartile range (Q1-Q3))
    		 40 (31 to 46) 32 (25 to 41) -
    HSS
    Units: arbitrary
        median (inter-quartile range (Q1-Q3))
    		 27 (6 to 51) 25.5 (7.0 to 136.5) -

    End points

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    End points reporting groups
    Reporting group title
    Withdrawal
    Reporting group description
    		 Participants randomized to discontinuation of alendronate treatment. Participants instead received placebo tablets.

    Reporting group title
    Alendronate
    Reporting group description
    		 Continued treatment with alendronate 70 mg weekly

    Primary: BMD lumbar spine

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    End point title
    		 BMD lumbar spine
    End point description
    Change in BMD of the lumbar spine from baseline to 24 months
    End point type
    Primary
    End point timeframe
    24 months
    End point values
    		 Withdrawal Alendronate
    Number of subjects analysed
    23
    27
    Units: g/cm2
        arithmetic mean (standard deviation)
    -0.010 ( 0.007 )
    0.027 ( 0.006 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Withdrawal v Alendronate
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    -0.037
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 -0.02

    Primary: CTX

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    End point title
    		 CTX
    End point description
    Change in CTX from baseline to 6 months
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Withdrawal Alendronate
    Number of subjects analysed
    23
    27
    Units: µg/L
        arithmetic mean (standard deviation)
    0.05 ( 0.02 )
    -0.01 ( 0.02 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Withdrawal v Alendronate
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0172
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.11

    Primary: P1NP

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    End point title
    		 P1NP
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Withdrawal Alendronate
    Number of subjects analysed
    23
    27
    Units: µg/L
        arithmetic mean (standard deviation)
    9.98 ( 4.38 )
    -8.95 ( 4.02 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Withdrawal v Alendronate
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0003
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.72
         upper limit
    		 29.13

    Secondary: BMD total hip

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    End point title
    		 BMD total hip
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Withdrawal Alendronate
    Number of subjects analysed
    23
    27
    Units: g/cm2
        arithmetic mean (standard deviation)
    -0.012 ( 0.006 )
    0.001 ( 0.005 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Withdrawal v Alendronate
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0547
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.013
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0

    Secondary: BMD lumbar spine

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    End point title
    		 BMD lumbar spine
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Withdrawal Alendronate
    Number of subjects analysed
    23
    27
    Units: g/cm2
        arithmetic mean (standard deviation)
    -0.012 ( 0.006 )
    0.001 ( 0.005 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Withdrawal v Alendronate
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0547
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.013
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0

    Secondary: BMD total hip

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    End point title
    		 BMD total hip
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Withdrawal Alendronate
    Number of subjects analysed
    23
    27
    Units: g/cm2
        arithmetic mean (standard deviation)
    -0.012 ( 0.06 )
    0.002 ( 0.005 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Withdrawal v Alendronate
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.034
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0

    Secondary: CTX

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    End point title
    		 CTX
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Withdrawal Alendronate
    Number of subjects analysed
    23
    27
    Units: µg/L
        arithmetic mean (standard deviation)
    0.02 ( 0.02 )
    0.00 ( 0.02 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Withdrawal v Alendronate
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.5481
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.08

    Secondary: P1NP

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    End point title
    		 P1NP
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Withdrawal Alendronate
    Number of subjects analysed
    23
    27
    Units: µg/L
        arithmetic mean (standard deviation)
    12.23 ( 5.48 )
    -6.71 ( 5.24 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Withdrawal v Alendronate
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0069
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.28
         upper limit
    		 32.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed at baseline, and at study visits at 3,6,12 and 24 months.
    Adverse event reporting additional description
    All patient-reported adverse events were recorded in a special file in the CRF and the electronic patient record (source data) and evaluated by a study investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Withdrawal
    Reporting group description
    		 Participants randomized to discontinuation of alendronate treatment. Participants instead received placebo tablets.

    Reporting group title
    Alendronate
    Reporting group description
    		 Continued treatment with alendronate 70 mg weekly

    Serious adverse events
    		 Withdrawal Alendronate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 23 (39.13%)
    11 / 27 (40.74%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignancies
         subjects affected / exposed
    2 / 23 (8.70%)
    4 / 27 (14.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    loss of BMD >5%
         subjects affected / exposed [1]
    6 / 21 (28.57%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Other fractures
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Some patients withdrew from the study before assessment of BMD loss >5%, hence they were not exposed to the assessment.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Withdrawal Alendronate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 27 (7.41%)
    Gastrointestinal disorders
    Upper GI diseases
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2018
    In protocol version2.0, the inclusion criterion "Diagnosed with osteopororsis with BMD less than or equal to-2.5 at the hip and/or the lumbar spine" was removed. However, ultimately no patients were included that did not fulfill the cirteria of osteoporosis diagnosed by DXA less than or equal to-2.5 at the hip and/or the lumbar spine.

    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
    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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