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    Summary
    EudraCT Number:2007-004633-41
    Sponsor's Protocol Code Number:CS 82-000-04
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-15
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2007-004633-41
    A.3Full title of the trial
    A Multicenter, Randomized, Parallel Study to Assess the Clinical Efficacy, Safety, and Tolerability of ViaDerm-hPTH (1-34) (Double-Blinded for 2 Different Dosages) in Comparison to Subcutaneous Injection of Forteo® Following 3-Month Treatment in Postmenopausal Women with Osteoporosis
    A.4.1Sponsor's protocol code numberCS 82-000-04
    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 SponsorTransPharma Medical
    B.1.3.4CountryIsrael
    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 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 nameViaDerm-hPTH (1-34)
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    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) 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 No
    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 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 holderEly Lilly
    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.3.1Product nameForsteo
    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.3.11 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 No
    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
    The population for this study is post-menopausal, osteoporosis-treatment naïve women, 55 years of age to 85 years of age, inclusive, with a lumbar vertebral BMD T-score of below or equal to -2.5.
    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
    •The change in procollagen 1 N-terminal Polypeptide (P1NP-1) from baseline to Day 96.
    E.2.2Secondary objectives of the trial
    • The change in CTX-1 from baseline to Day 96. • Repeated measurements analysis of P1NP using Mixed model to test the treatment effect and the time effect. • Repeated measurements analysis of CTX-1 using Mixed model to test the treatment effect and the time effect. • hPTH (1-34) Pharmacokinetic parameters (AUC, Cmax, ) of ViaDerm-hPTH (1-34) and Forteo SC at baseline and Day 96/early termination. • Compare the ratio of hPTH (1-34) AUC of transdermal treatment and Forteo SC. • Compare the ratio of hPTH (1-34) Cmax of transdermal treatment and Forteo SC. Safety Endpoints: • Percentages of patients with serum total calcium level exceeding the upper limit of the normal range. • Percentages of patients with serum total calcium level more than 1 mg/dl above the upper limit of the normal range.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female subjects; 2. Age 55 to 85 years old, inclusive, at the time of dosing with study drug; 3. Determined to be postmenopausal, defined as: • No menstrual periods >36 consecutive months before the study; or • Surgical menopause >36 months (bilateral oophorectomy with or without hysterectomy) before the study and a serum follicle-stimulating hormone (FSH) level 30 mIU/mL; 4. Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA -2.5 SD at screening. 5. Have serum 25-OH D (25-dihydroxyvitamin D) level of >20 ng/mL at Screening Visit 1; If serum 25-OH D is ≤20 ng/mL, patients may be given vitamin D supplements and re-tested 4 to 12 weeks later; 6. Have normal serum PTH at screening visit 1 (test acceptable up to 6months prior to screening), and thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone); 7. Have the following values: • Serum total calcium <10.3 mg/dL; • Serum creatinine <1.6 mg/dL; • Phosphate > 2.5mg/dL; • AST and ALT <2x the upper limit of normal; • Total bilirubin <2 mg/dL; • Alkaline phosphatase <150 U/L; • Hemoglobin >11 gm/dL; • White blood cell count >4000x109; • Platelet count >100,000 x109/L; • 24-hour urine calcium <300 mg/day; • Urine creatinine >500 mg/day; 8. Able to understand and provide written informed consent before any study procedures take place; 9. Able to be reached by telephone for follow-up contact between visits.
    E.4Principal exclusion criteria
    1. Subjects who have a clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation. Such conditions may include the conditions listed below, as determined by medical history, physical examination, laboratory tests or ECG. • Cushing’s disease; • Osteogenesis imperfecta; • Known blood disorders; • Any kidney stone within the past 5 years, or multiple prior kidney stones; • Impaired renal function (creatinine clearance [CrCl] <30 mL/min); • Active hepatitis; • Active pancreatitis; • Unstable pulmonary disease; • Uncontrolled Celiac disease; • Severe unstable symptomatic vascular disease; • Active Inflammatory bowel syndrome; • Seizure disorders treated with phenobarbital or phenytoin; • Any other previous or ongoing clinically significant illness, including any neurological or psychiatric disease, that would interfere with the patient’s ability to comply with the study protocol or could prevent the patient from completing the study; 2. Patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, or prior external beam or implant radiation therapy involving the skeleton); 3. Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease 4. Use of a pacemaker; 5. Clinically and symptomatically diagnosed with bone fracture in the last 6 months, excluding fracture in finger and/or tow; 6. Any condition or disease that may interfere with the ability to have, or to evaluate a DXA scan, for example: • Severe osteoarthritis of the spine; • Spinal fusion; • Pedicle screws; • History of vertebroplasty; and • Degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or >2 lumbar vertebral fractures; 7. Alcohol abuse within 2 years; 8. Drug abuse (prescribed and non-prescribed) in the past 2 years; 9. History of cancer that includes any cancer within the previous 5 years, except squamous or basal cell carcinoma of the skin in which the lesions were fully resected with clear margins described in a written report by a pathologist, and the patient has had no recurrence of lesions for ≤1 year from the time of original resection; 10. Have a past history of ionizing radiation in therapeutic (not diagnostic) doses that include bone; 11. Blood donation within 4 weeks prior to the start of dosing or plasma donation within 7 days of dosing; 12. Prior osteoporosis treatment with fluoride or strontium at any time; 13. Have received any intravenous (IV) administration bisphosphonates in the past; 14. Have received treatment with oral bisphosphonate for more than 1 month (accumulated in total) in the past 24 months prior to randomization (Bisphosphonates are including, but not limited to, alendronate, risedronate, ibandronate, tiludronate, clodronate, pamidronate, and etidronate, zoledronate, ibandronate, etidronate); 15. Have not had a washout period of at least 3 times the duration of the treatment received with oral bisphosphonates prior to randomization; 16. Use of the following therapies for the specified times before randomization in this study; • Any investigational drug within 60 days; • Anabolic steroids or androgens within 6 months; • Vitamin D metabolites and analogs, e.g., calcitrol, within 90 days; • Daily inhaled corticosteroids of beclomethasone 1200 μg/day or equivalent within 3 months; • Calcitonin, oral glucocorticoids, or thyroxine in doses that suppress the patient’s serum TSH below the lower limit of the normal range; • Lithium; • Pharmacological doses of vitamin D (greater than 2,000 IU/day) unless the patient subsequently have a serum 25-OH D < 90 ng/ml prior to randomization; • Anticonvulsants; • Estrogen (oral, or cutaneous) or estrogen-related drugs, (i.e., tamoxifen, tibolone [oral or skin patch], or raloxifene) within 6 months; • Progestin or anti-estrogen within 6 months; • Coumadin within 4 weeks or heparin within 1 week; 17. Patients receiving thyroid hormone replacement therapy who had dose adjustments or TSH out of range within 6 weeks of the study; 18. Have known dermatological disorders that would interfere with the study procedures or assessments, or with a history of contact dermatitis; 19. Have known allergy or sensitivity to tapes, adhesives, PTH, teriparatide or its analogs, or components of the ViaDerm system; 20. Are not capable of following the study schedule for any reason, or in the opinion of the Investigator, should not participate in the study; or 21. Unwillingness or inability to abide by the requirements of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The change in procollagen 1 N-terminal Polypeptide (P1NP-1) from baseline to Day 96.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Forsteo
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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 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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 93
    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 care according to everyday medical practice.
    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 Decision2008-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-09
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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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