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    The EU Clinical Trials Register currently displays   36059   clinical trials with a EudraCT protocol, of which   5925   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-004796-11
    Sponsor's Protocol Code Number:CZOL446GDE24
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-004796-11
    A.3Full title of the trial
    An Open-Label, Non-Randomized, Single center Study to Evaluate the Use of Zoledronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women with ER+ and/or PgR+ Breast Cancer Receiving Letrozole as Adjuvant Therapy
    A.4.1Sponsor's protocol code numberCZOL446GDE24
    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 SponsorKlinikum Augsburg
    B.1.3.4CountryGermany
    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 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 Yes
    D.2.1.1.1Trade name Zometa
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma Gmbh
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Femara
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLetrozol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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.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
    Prevention of cancer treatment-related bone loss in postmenopausal women with resected stage I-IIIa hormone receptor positive breast cancer, who will receive letrozole as adjuvant therapy.
    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
    To monitor the BMD in the lumbar spine (L1 to L4), as measured by Q-CT in postmenopausal women with hormone receptor positive breast cancer 12 months after registration.
    E.2.2Secondary objectives of the trial
    1. To monitor the BMD in the lumbar spine (L1 to L4) as measured by Q-CT 24, 36
    and 60 months after registration.
    2. To determine the incidence rate of all clinical fractures at 3 years after registration.
    3. To evaluate the general safety of the treatment.
    4. To describe the time to disease recurrence/relapse at 5 years after registration.
    5. To describe overall survival at 5 years after registration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must fulfill all of these inclusion criteria:
    1. Signed written informed consent.
    2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 – 2
    3. Postmenopausal status defined by one of the following:
    • Age >/= 55 years with cessation of menses.
    • Age <55 but no spontaneous menses for at least 1 year.
    • Age <55 and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous, or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (luteinizing hormone and follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (<5ng/dL) or according to the definition of “postmenopausal range” for the laboratory involved.
    • Bilateral oophorectomy.
    4. Hormone receptor positive defined as ER and/or PgR >/= 2 (Remmele/Stegner)
    5. Patients with a baseline lumbar spine BMD T-score at or above - 2.0 SD.
    6. Adequately diagnosed and treated invasive breast cancer defined as:
    • Patients with invasive breast cancer whose tumor can be removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery and who receive, if appropriate, additional local (e.g. radiotherapy) and/or systemic (i.e. adjuvant chemotherapy) treatments, according to best practice.
    • Patients may have also received prior neoadjuvant chemotherapy. Prior neoadjuvant chemotherapy must be completed before entering the patient onto the present protocol.
    • The date of registration must be no more than:
    a. 4 weeks from completion of surgery (in case of surgery alone), or
    b. 4 weeks from completion of surgery (in case of surgery + radiotherapy) or
    c. 4 weeks after completion of adjuvant chemotherapy (if planned to be given before the endocrine therapy) or
    d. 4 weeks after completion of chemotherapy followed by radiation.
    Completion of chemotherapy is defined as completion of the last full course including recovery time.
    • When the plan is to give concomitant adjuvant chemotherapy and hormonotherapy, the treatment should start at the same time and the date of registration must be no more than 4 weeks from completion of surgery;
    • Patients must have no clinical or radiological evidence of distant metastasis, and no other concomitant malignancy.
    7. Patients must be able to swallow the study medication and have adequate unassisted oral intake to maintain a reasonable state of nutrition.
    8. Life expectancy of at least 12 months from registration.
    E.4Principal exclusion criteria
    1. Patients with any clinical or radiological evidence of distant spread of their disease at any point before registration.
    2. Patients with invasive bilateral breast cancer.
    3. Patients with any clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip.
    4. Patients with a history of fracture with low-density or no associated trauma.
    5. Patients who have started adjuvant hormonal therapy or who have completed adjuvant hormonal therapy prior to registration.
    6. Patients who have received any endocrine therapy within the past 12 months (other than neoadjuvant tamoxifen or torimefene, insulin and/or anti-diabetic medications, and thyroid hormone replacement). Hormone replacement therapy must be discontinued at least 4 weeks prior to registration.
    7. Patients currently receiving oral bisphosphonates. Oral bisphosphonates must be discontinued within 3 weeks of baseline evaluations.
    8. Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting is allowed).
    9. Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months.
    10. Treatment with tibolone must be discontinued at least 4 weeks prior to registration.
    11. Any prior use of parathyroid hormone (PTH) for more than 1 week.
    12. Prior use of systemic sodium fluoride for > 3 months during the past 2 years.
    13. Patients currently treated with any drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate) within 2 weeks prior to registration.
    14. Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease-free for five years.
    15. Patients with other non-malignant systemic diseases including uncontrolled infections, uncontrolled type 2 diabetes mellitus, uncontrolled thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged follow-up. Patients with previous history of thrombosis or thromboembolism can be included only if suitable for prolonged follow-up and not on steroids. Patients with a known history of HIV are excluded.
    16. A calculated creatinine clearance < 30 ml/minute.
    Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:
    CrCl= [140-age (years)] x weight (kg) {x 0.85 for female patients}
    -------------------------------------------
    [72 x serum creatinine (mg/dL)]
    17. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
    18. Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).
    19. History of diseases with influence on bone metabolism, such as Paget’s disease, Osteo-genesis Imperfecta, and primary or secondary hyperthyroidism within the 12 months prior to study entry.
    20. Patients with baseline lumbar spine BMD T-score below –2.0 SD.
    21. Known hypersensitivity to zoledronic acid or other bisphosphonates.
    22. Mental illness that precludes the patient from giving informed consent.
    23. WBC </= 3.0 x 109/L or granulocytes </= 1.5 x 109/L, platelets </= 100 x 109/L.
    24. AST/SGOT and/or ALT/SGPT >3ULN in combination with other laboratory and clinical abnormalities indicating liver insufficiency to a degree that precludes dosing with letrozole (Child-Pugh grade C).
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to estimate the influence of Zoledronic acid on BMD (DXA) measured in lumbar spine (L1 to L4), as measured by Q-CT in postmenopausal women with hormone receptor positive breast cancer 12 months after registration.
    BMD (DXA) will be evaluated at baseline and at 12 months after start of treatment. The difference of both measured values of BMD describes the effect of the treatment and constitute the primary efficiacy variable.
    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 Yes
    E.6.5Efficacy Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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
    Patients will be treated on study until disease recurrence or for a maximum of 5 years.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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)
    After the end of the trial treatment is again at the physician´s discretion
    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 Decision2007-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-16
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