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    Summary
    EudraCT Number:2006-006315-68
    Sponsor's Protocol Code Number:B3D-EW-GHDH
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-29
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-006315-68
    A.3Full title of the trial
    Comparison of the Effects of Teriparatide with those of Risedronate on Lumbar Spine Volumetric Bone Mineral Density in Glucocorticoid-Induced Osteoporosis in Men
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberB3D-EW-GHDH
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name FORSTEO SC 1PEN 3ML20MCG/80MCL
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY ITALIA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 ACTONEL
    D.2.1.1.2Name of the Marketing Authorisation holderPROCTER GAMBLE SRL
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    treatment males with glucocorticoid-induced osteoporosis GIOP
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031282
    E.1.2Term Osteoporosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to test the hypothesis that teriparatide 20 956;g subcutaneously once daily is superior to risedronate 35 mg orally once weekly in the change from baseline to 18 months of lumbar spine volumetric trabecular bone mineral density in males with glucocorticoid-induced osteoporosis. All patients will receive elemental calcium 1000 mg orally once daily and vitamin D 800-1200 IU orally once daily.
    E.2.2Secondary objectives of the trial
    to test the hypothesis that Teriparatide is superior to risedronate in several aspects -The improvement of the lumbar spine volumetric trabecular and integral BMD as measured by QCT at 6 months and at 6 and 18 months of treatment.-The improvement of the 3D microstructural variables as measured by HR-QCT in the T-12 at 6 and 18 months.-The improvement of the biomechanical variables evaluated by a finite element analysis in the T-12 at 6 and 18 months of treatment.To compare the effects of both treatments on areal BMD response at the lumbar spine, femoral neck, and total hip, at 18 months of treatment, and on biochemical markers of bone turnover including P1NP and serum type -CTx at at 3, 6 and 18 months of treatment. to evaluate safety. to examine the relationship between biochemical markers of bone turnover and the high-resolution quantitative computerized tomography variables, including finite element analysis, at 6 and 18 months of therapy with teriparatide or risedronat
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Ambulatory men 25 years of age and older presenting to Visit 1 with a BMD of at least 1.5 SD below the corresponding normal young adult men average BMD T score of 1.5 or lower , at any of the following regions of interest total hip, femoral neck, or lumbar spine. Have received glucocorticoid therapy at an average dose of at least 5.0 mg/day of prednisone or its equivalent for a minimum of 3 consecutive months immediately preceding screening Visit 1 , as determined by medical history rare exceptions may be enrolled if previously approved A minimum of 2 lumbar vertebrae in the L-1 through L-3 region must be evaluable by quantitative computerized tomography. Normal or clinically insignificant abnormal laboratory values including serum calcium, PTH 1 84 , and 25 hydroxyvitamin D concentrations, and alkaline phosphatase activity
    E.4Principal exclusion criteria
    Presence of a mild, moderate or severe spinal fracture in both T-12 and L-1, as determined by the central reading facility using the semiquantitative technique by Genant et al. 1993 . Patients with a normal vertebral body height i.e.; vertebral height reduction 20 either at T-12 or L-1 are eligible for the study see section 6.1.2.2 . Abnormal albumin-corrected serum calcium levels as determined by the investigators site laboratory. History of unresolved skeletal diseases that affect bone metabolism other than glucocorticoid-induced osteoporosis. History of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. Increased baseline risk of osteosarcoma; this includes patients with Paget s disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation. As elevation of serum skeletal alkaline phosphatase activity may indicate the presence of Paget s disease, an unexplained elevation of this enzyme activity will also be exclusionary. History of symptomatic nephro- or urolithiasis in the year prior to Visit 2. Abnormal thyroid function not corrected by therapy. Normal thyroid function may be documented by a normal serum thyroid-stimulating hormone TSH value during the screening phase or a combination of clinical and biochemical parameters which, in the judgment of the investigator and the Lilly clinical research physician, sufficiently establishes the presence of normal thyroid function. Significantly impaired renal function as defined by measured or calculated endogenous creatinine clearance 30 mL/min using the Cockcroft-Gault formula for creatinine clearance. History of excessive consumption of alcohol or abuse of drugs in the 1 year prior to Visit 2, in the opinion of the investigator. Poor medical condition or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator. History of bone marrow or solid organ transplantation. Treatment with any other drug except corticosteroids in the 6 months prior to Visit 2, if that drug is believed by the investigator to significantly affect bone or calcium metabolism. Treatment with - Fluoride at therapeutic doses 20 mg/day for more than 3 months in the 2 years prior to Visit 2, or for more than a total of 2 years, or at any dosages within the 6 months prior to Visit 2. Previous or current use of fluoridated water or topical dental fluoride treatment is permitted - Strontium ranelate for any duration - Intravenous bisphosphonates, at any dose, within the 12 months prior to Visit 2. Previous treatment for any duration with calcitonin, oral bisphosphonates or active vitamin D3 analogues is allowed, but it should be stopped by the randomization visit. Have received treatment within the last 30 days with a drug not including study drug that has not received regulatory approval for any indication at the time of study entry. Known allergy to teriparatide or risedronate, any diluents or excipients of teriparatide, or to any other form of PTH or PTH analog. Presence of any condition which contraindicates risedronate therapy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measurement in this study is the change in actual lumbar spine volumetric trabecular BMD vBMD as determined by quantitative computerized tomography QCT from baseline to 18 months. For QCT of the spine L1-L3 will be scanned completely, slice thickness 3 mm, i.e.; 25-35 slices for a vertebral range of approximately 8-12 cm, 80 kV, and 140 mAs.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 104
    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 Decision2007-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-06
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