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    Summary
    EudraCT Number:2010-020040-35
    Sponsor's Protocol Code Number:CL0002
    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:2010-08-25
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-020040-35
    A.3Full title of the trial
    Pharmacokinetics of hPTH (1-34) delivery with
    MicroCHIPS’ implantable reservoir array
    device.
    A.4.1Sponsor's protocol code numberCL0002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMicroCHIPS
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Forsteo
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V, Grootslag 1-5, NL-3991 RA Houten, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameForsteo
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTERIPARATIDE
    D.3.9.1CAS number 52232-67-4
    D.3.9.3Other descriptive nameParathyroid hormone
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Yes
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.IMP: 2
    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 No
    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 nameNot applicable
    D.3.2Product code Teriparatide
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPImplant use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTERIPARATIDE
    D.3.9.1CAS number 52232-67-4
    D.3.9.2Current sponsor codehPTH
    D.3.9.3Other descriptive nameParathyroid hormone
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number65 to 75
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Yes
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Osteopenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10031282
    E.1.2Term Osteoporosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10049088
    E.1.2Term Osteopenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study is being undertaken to assess the pharmacokinetics of hPTH(1-34) as delivered by MicroCHIPS’ implantable delivery system and to evaluate the safety of hPTH(1-34) delivery with this system in postmenopausal women age 50 to 70 with low BMD as defined by DEXA spine, total hip, or femoral neck. This includes women with osteopenia (T-score between -1.5 (BMD values for spine 1.000 g/cm2 , for total hip 0.820 g/cm2 and for femoral neck 0.800 g/cm2) and -2.5 (BMD values for spine 0.880 g/cm2, for total hip 0.700 g/cm2 and for femoral neck 0.680 g/cm2)) and a history of at least one fragility fracture and women with osteoporosis (T-score ≤ -2.5). The results of this trial will be used to support future product development and research efforts.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Woman age ≥ 50 and ≤ 70
    • Postmenopausal by the following criteria:
    ≥ 12 months since last spontaneous menses, serum FSH value > 20 mIU/L
    • BMD defined by DEXA spine, total hip, or femoral neck with either a T score ≤-1.5 (BMD values for spine 1.000 g/cm2 , for total hip 0.820 g/cm2 and for femoral neck 0.800 g/cm2) and >-2.5 (BMD values for spine 0.880 g/cm2, for total hip 0.700 g/cm2 and for femoral neck 0.680 g/cm2) and a history of at least one fragility fracture, or a T-score ≤ -2.5
    • Body mass index (BMI) between 18.5 and 29.9 kg/m2.
    • Judged to be in good health, i.e. without major or clinically relevant pathology, on the basis of medical history, physical examination and routine laboratory measurements (full blood chemistry profile and CBC with differential).
    • Normal Thyroid function (clinically or with TSH if on thyroid hormone)
    • Subjects accepts supplemental vitamin D treatment as a booster for 4-6 weeks if serum 25(OH)D at the time of screening is below 20 ng/ml. Maintenance vitamin D / calcium replacement is recommended at the discretion of the physician for the period of the trial.
    • Subject is willing and able to undergo local anesthesia for both device insertion and explantation. Subject agrees that a tissue biopsy will be taken from the implantation site during explantation.
    • Subject agrees to avoid physical activity that could put the implant at risk for at least two weeks after device implantation.
    • Subject understands the nature of the procedures and is willing to comply with associated clinic visits for blood drawings and follow-up evaluations. In the opinion of the investigator, subject can comply with all study requirements.
    • Subject understands the content and is willing and able to sign the informed consent form.
    E.4Principal exclusion criteria
    • Exposure to bone active drugs within the past 6 months (e.g. calcitonin, raloxifene, estrogens) any exposure to injectable bisphosphonates (Reclast®) ever, exposure to oral bisphosphonates if used for more than 6 months in the past 5 years or more than one year previously,
    • Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months,
    • Current diagnosis of Paget’s disease or unexplained high levels of alkaline phosphatase in blood,
    • History of any illness that is documented or known and that interferes with bone or calcium metabolism or that might pose an additional risk to the subject or confound the results of the study. This includes, but is not limited to: stones of the kidneys and urinary tract, history of any malignancy and treatment of the condition diabetes, a clinically significant coagulopathy, compromised immune function, hepatitis.
    • Subject has a history of cardiovascular disease and has a cardiac pacemaker, a cardioverter-defibrillator or a similar device that may be sensitive to radio frequency telemetry.
    • The patient presents with a baseline hematocrit of <32 %.
    • Serum 25(OH)D below 10ng/ml.
    • At the discretion of the investigators a judgment will be made on the withholding of treatment with medications and supplements, i.e. herbal therapies, interfering with bone or calcium metabolism. Maintenance vitamin D/calcium therapy is acceptable.
    • Subject has a known sensitivity to the relevant drug, to local anesthetic agents, suture materials or implant materials.
    • The subject has any condition that precludes him/her from completing the protocol.
    • History of drug or alcohol abuse within 2 years prior to study enrollment.
    • Subject has a planned MRI prior to anticipated explantation date.
    • Subject is involved in strenuous contact sports or is required to perform heavy physical workloads.
    • Subject has participated in a clinical trial of another investigational drug or device within the past 30 days or has not completed the required follow-up period.
    E.5 End points
    E.5.1Primary end point(s)
    Subcutaneous releases of hPTH(1-34) shall be assessed from plasma samples and are expected to appear in a pulsatile and reproducible manner. Pharmacokinetic profiles of hPTH(1-34) will be analyzed by calculating AUC, Tmax, Cmax, and elimination rate based on plasma measurements performed on days 4±1, 11±2 and 18±2(subject to change as above) during the device dosing period. Intra- and inter-subject reproducibility/variability parameters of the profiles will be assessed. Initial findings will serve as an estimate for future statistical power calculations.
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.7.1.3.1Other trial type description
    Device
    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 Yes
    E.8.1.1Randomised No
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state12
    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)
    2 Free clinic examinations after completion, and 1 year free osteoporosis 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 Decision2010-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-17
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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
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