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    Summary
    EudraCT Number:2022-000178-24
    Sponsor's Protocol Code Number:W2021.040
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-04-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-000178-24
    A.3Full title of the trial
    Active vitamin D for secondary hyperparathyroidism after bariatric surgery: a multicenter randomized controlled trial.
    Behandeling van secundaire hyperparathyreoidie na bariatrische chirurgie met actief vitamine D: the ActiVitD trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    treatment of elevated parathyroid hormone with active vitamin D (alfacalcidol) after bariatric surgery
    behandeling van verhoogd bijschildklierhormoon met actieve vitamine D (alfacalcidol) na bariatrische chirurgie
    A.3.2Name or abbreviated title of the trial where available
    ActiVitD trial
    A.4.1Sponsor's protocol code numberW2021.040
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Etalpha
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with secondary hyperparathyroidism after Roux-en-Y gastric bypass surgery (RYGB).
    patiënten met secundaire hyperparathyreoïdie na Roux-en-Y gastric bypass-operatie (RYGB).
    E.1.1.1Medical condition in easily understood language
    patients with elevated parathyroid hormone after gastric bypass surgery
    patienten met een verhoogd bijschilklierhormoon na een gastric bypass operatie
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    - to investigate the effect of alfacalcidol on the treatment of secondary hyperparathyroidism in patients after RYGB
    Hoofddoel:
    - om het effect te onderzoeken van alfacalcidol op de behandeling van secundaire hyperparathyreoïdie bij patiënten na RYGB
    E.2.2Secondary objectives of the trial
    Secondary Objective(s):
    - to investigate bone turnover and changes in BMD (bone mineral density) in relation to alfacalcidol treatment of secondary hyperparathyroidism in patients after RYGB
    - to investigate quality of life, medication adherence and cost benefits related to hyperparathyroidism and medication intake in patients after RYGB
    Secundaire doelstelling(en):
    - onderzoek naar botturnover en veranderingen in botdichtheid in relatie tot behandeling met alfacalcidol van secundaire hyperparathyreoïdie bij patiënten na RYGB
    - onderzoeken van kwaliteit van leven, therapietrouw en kostenvoordelen gerelateerd aan hyperparathyreoïdie en medicatie-inname bij patiënten na RYGB
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Men and both pre- and postmenopausal women who have had Roux-en-Y-gastric bypass surgery and present with secondary hyperparathyroidism after surgery, with a vitamin D sufficient state (>50 nmol/l), and only on standard supplementation, are included.
    Om in aanmerking te komen voor deelname aan dit onderzoek, moet een proefpersoon aan alle volgende criteria voldoen:
    - Mannen en zowel pre- als postmenopauzale vrouwen die een Roux-en-Y-gastric bypass-operatie hebben ondergaan en zich presenteren met secundaire hyperparathyreoïdie na de operatie, met een vitamine D voldoende toestand (>50 nmol/l), en alleen op standaard suppletie, kunnen worden geincludeerd
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - Patients who are already on active treatment for osteoporosis before inclusion
    - Patients with chronic kidney disease defined as eGFR < 60 ml/min
    - Patients who had a bariatric intervention before and are re-operated
    - Patients that are on chronic steroid use, for example for inflammatory conditions
    - Patients that appear to have hypercalcemia on screening
    - Patients with known inflammatory conditions (i.e. rheumatoid arthritis)
    - Patients that have an active pregnancy wish
    Een potentiële proefpersoon die aan een van de volgende criteria voldoet, wordt uitgesloten van deelname aan dit onderzoek:
    - Patiënten die al een actieve behandeling voor osteoporose ondergaan vóór opname
    - Patiënten met chronische nierziekte gedefinieerd als eGFR < 60 ml/min
    - Patiënten die eerder een bariatrische ingreep hebben ondergaan en opnieuw worden geopereerd
    - Patiënten die chronisch steroïden gebruiken, bijvoorbeeld voor ontstekingsaandoeningen
    - Patiënten die bij screening hypercalciëmie lijken te hebben
    - Patiënten met bekende ontstekingsaandoeningen (d.w.z. reumatoïde artritis)
    - Patiënten met een actieve zwangerschapswens
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome parameters: normalization of PTH (and thus recovery of secondary hyperparathyroidism) at 1 and 2 years after diagnosis and start of treatment in one of the study groups. Secondary hyperparathyroidism will be defined as PTH at the upper limit or above the labs reference value combined with a normal or decreased serum calcium level (in patients with 25(OH)D >50 nmol/L).
    Primaire uitkomstparameters: normalisatie van PTH (en daarmee herstel van secundaire hyperparathyreoïdie) 1 en 2 jaar na diagnose en start van behandeling in een van de onderzoeksgroepen. Secundaire hyperparathyreoïdie wordt gedefinieerd als PTH bij de bovengrens of boven de laboratoriumreferentiewaarde gecombineerd met een normale of verlaagde serumcalciumspiegel (bij patiënten met 25(OH)D >50 nmol/L).
    E.5.1.1Timepoint(s) of evaluation of this end point
    xxx
    xxx
    E.5.2Secondary end point(s)
    Secondary outcome parameters: decrease in BMD (defined as 3% decrease in T-score at the lumbar spine and 5% decrease in T-score at the hip / forearm), measured at 1 and 2 years after inclusion. As DEXA BMD measurements at regular sites (hip, spine) depend on body weight and circumference to a certain extent, BMD measurement of the forearm will be performed because this site is known to be less influenced by surrounding tissue. For a reflection on bone turnover, serum bone turnover markers (P1NP, b-crosslaps, alkaline phosphatase) will be measured.
    Secundaire uitkomstparameters: afname in botdichtheid (gedefinieerd als 3% afname in T-score bij de lumbale wervelkolom en 5% afname in T-score bij heup/onderarm), gemeten 1 en 2 jaar na inclusie. Aangezien DEXA metingen op reguliere plaatsen (heup, wervelkolom) tot op zekere hoogte afhankelijk zijn van het lichaamsgewicht en de omtrek, zal de botdichtheidsmeting van de onderarm worden uitgevoerd omdat bekend is dat deze plaats minder wordt beïnvloed door omringend weefsel. Voor een reflectie op botturnover zullen serum botturnover markers (P1NP, b-crosslaps, alkalische fosfatase) gemeten worden.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, after 1 year, after 2 years of tretment
    Op baseline en na 1 jaar en 2 jaar behandeling
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    laatste visite, laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 130
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    standard treatment
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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