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    Summary
    EudraCT Number:2015-005529-37
    Sponsor's Protocol Code Number:07.12.2015
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-15
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-005529-37
    A.3Full title of the trial
    Treatment with zoledronic acid subsequent to denosumab in osteoporosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with zoledronic acid subsequent to denosumab in osteoporosis
    A.4.1Sponsor's protocol code number07.12.2015
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBente Lomholt Langdahl
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Osteoporosis Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. of Endocrinology and Internal Medicine, Aarhus University Hospital
    B.5.2Functional name of contact pointBente Lomholt Langdahl
    B.5.3 Address:
    B.5.3.1Street AddressTage-Hansens Gade 2
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.6E-mailbenlan@rm.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 Aclasta / Zoledronic acid
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.1Product namezoledronic acid (ZOL)
    D.3.2Product code M05BA08
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZOLEDRONIC ACID
    D.3.9.1CAS number 118072-93-8
    D.3.9.4EV Substance CodeSUB00176MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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
    Osteoporosis
    E.1.1.1Medical condition in easily understood language
    Osteoporosis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031289
    E.1.2Term Osteoporosis, unspecified
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate if infusion of zoledronic acid can prevent increases in bone turnover and bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronic acid at six or nine months after the last injection with denosumab or when bone turnover is increased.
    E.2.2Secondary objectives of the trial
    To investigate if infusion of zoledronic acid can prevent increases in bone turnover and bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronic acid at six or nine months after the last injection with denosumab or when bone turnover is increased.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    • Postmenopausal women (postmenopausal for at least two years)
    • Men above 50 years
    • Treatment for at least two years with denosumab
    • Last denosumab injection less than five months ago
    E.4Principal exclusion criteria
    Exclusion criteria
    • Low-energy vertebral fracture at any time
    • Low-energy hip fracture within the last 12 months
    • BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)
    • Alendronate treatment for more than three years prior to denosumab treatment
    • Ongoing treatment with glucocorticoids
    • Metabolic bone disease
    • Hormone replacement therapy
    • Cancer
    • Estimated glomerular filtration rate (eGFR) < 35 mL/min
    • Allergy to zoledronic acid
    • Hypocalcaemia
    • Contraindications for zoledronic acid according to the SPC
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary endpoint
    • Change in lumbar spine BMD from baseline to 6 months after the zoledronic acid infusion.
    • The proportion of patients who fails to maintain BMD (total hip, femoral neck and spine). Failure is defined as ≥ 3 % BMD loss at the lumbar spine or ≥ 5 % BMD loss at the femoral neck or total hip.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Co-primary endpoint
    • Change in lumbar spine BMD from baseline to 6 months after the zoledronic acid infusion.
    • The proportion of patients who fails to maintain BMD (total hip, femoral neck and spine). Failure is defined as ≥ 3 % BMD loss at the lumbar spine or ≥ 5 % BMD loss at the femoral neck or total hip.
    E.5.2Secondary end point(s)
    Secondary endpoints
    • Changes in total hip, femoral neck and lumbar spine BMD from baseline to one year after the zoledronic acid infusion.
    • Changes in total hip, femoral neck and lumbar spine BMD from baseline to two years after the zoledronic acid infusion.
    • Changes in trabecular bone volume fraction (bone volume/tissue volume, BV/TV) and cortical porosity measured by high-resolution peripheral quantitative computed tomography (HR-pQCT) scan at the radius and tibia from baseline to one year after the zoledronic acid infusion.
    • Changes in CTX and procollagen type I N-terminal propeptide (PINP) from baseline to six months after the zoledronic acid infusion.
    • Changes in CTX and PINP from baseline to 12 months after the zoledronic acid infusion.
    • Morphometric vertebral fractures assessed by vertebral fracture assessment (VFA) one and two years after the zoledronic acid infusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Changes in total hip, femoral neck and lumbar spine BMD from baseline to 1 year after the ZOL infusion.
    • Changes in total hip, femoral neck and lumbar spine BMD from baseline to 2 years after the ZOL infusion.
    • Changes in trabecular bone volume fraction and cortical porosity measured by HR-pQCT scan at the radius and tibia from baseline to 1 year after the ZOL infusion.
    • Changes in CTX and PINP from baseline to 6 months after the ZOL infusion.
    • Changes in CTX and PINP from baseline to 12 months after the zoledronic acid infusion.
    • Morphometric vertebral fractures assessed by vertebral fracture assessment (VFA) one and two years after the zoledronic acid infusion.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned4
    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
    The study will be stopped immediately if regular, serious, or life threatening side effects comes to the investigator's knowledge. The study will be terminated for single participants if the investigator suspects that the participant will be in risk of serious, life-threatening events if he or she continues as part of the study.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    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)
    The patients will be referred to the outpatient clinics at Aarhus University Hospital, Odense University Hospital, Regional Hospital Horsens or Regional Hospital Silkeborg after termination of the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Department of Internal Medicine, Regional Hospital Horsens
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Department of Internal Medicine, Regional Hospital Silkeborg
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Department of Endocrinology and Internal Medicine, Odense University Hospital
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-30
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