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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43692   clinical trials with a EudraCT protocol, of which   7246   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2005-003033-41
    Sponsor's Protocol Code Number:2005040
    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:2005-12-27
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2005-003033-41
    A.3Full title of the trial
    A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 12 Month, Multicenter, Double-blind, Randomized, Parallel Group Study Comparing Weekly Oral Risedronate 35 mg and Placebo
    A.4.1Sponsor's protocol code number2005040
    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 SponsorProcter & Gamble Technical Centres Limited
    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.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 Information not present in EudraCT
    D. name Actonel einmal wöchentlich 35 mg Filmtabletten
    D. of the Marketing Authorisation holderProcter & Gamble Pharmaceuticals - Germany 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.3.1Product nameRisedronate Sodium 35 mg (Actonel 35 mg)
    D.3.2Product code NE-58095
    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 INN[1-hydroxy-2-(3-pyridinyl) ethylidene] bis[phosphonic acid] monosodium salt
    D.3.9.1CAS number 105462-24-6
    D.3.9.2Current sponsor codeRisedronate sodium
    D.3.9.3Other descriptive nameRisedronic acid
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoporosis is a systemic skeletal disorder characterized by low bone mass and micro-architectural deterioration of bone tissue leading to enhanced bone fragility and susceptibility to fracture.
    Postmenopausal women with a diagnosis of osteopenia (T score between –2.5 and –1.0 based on the World Health Organization classification) may also be at risk of fracture.

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level PT
    E.1.2Classification code 10031285
    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 evaluate the ability of 3D pQCT to detect a treatment difference with respect to distal radius trabecular bone volume (BV/TV) percent change from Baseline over a 12-month period among osteopenic early postmenopausal women treated with risedronate 35 mg as compared to those treated with placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the percent change from Baseline between the 2 treatment groups for the following measurements:

    • BMD of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using dual energy X ray absorptiometry (DXA) scan;

    • 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data; and

    • bone turnover markers (BTMs) of fasting serum carboxyterminal cross linking telopeptide of Type 1 bone collagen (CTX 1) and serum aminoterminal propeptide of Type 1 procollagen (PINP).

    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Women meeting all of the following criteria are eligible for randomization into the study:

    a) ambulatory;

    b) between 40 and 55 years of age, inclusive;

    c) cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment and postmenopausal estradiol laboratory values (estradiol <or= 40 pg/mL and follicle simulating hormone [FSH] >or= 30 mIU/mL);

    d) has osteopenia (as defined in the protocol);

    e) must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)

    f) BMI between 18 and 28 kg/m2, inclusive;

    g) negative urine (dipstick) pregnancy test (to be done prior to radiation exposure in the screening evaluation);

    h) in generally good health as determined by medical history, physical examination, and laboratory tests; and

    i) are willing and able to participate in the study and to provide written informed consent.

    E.4Principal exclusion criteria
    Patients will not be admitted into the study if they exhibit any of the following:

    a) documented history of illicit drug abuse or alcohol abuse (for the past 2 years);

    b) evidence of significant psychiatric or organic disease (particularly a history of malignant disease [excluding skin epitheliomas], gastrointestinal, hepatic, renal, or cardiac disease), which, in the opinion of the investigator and the medical monitor, would prevent the patient from completing the study;

    c) history of tremor disorder;

    d) history of hyperparathyroidism or recent thyroid disorder;

    e) history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease, or any known condition that would interfere with the assessment of DXA at either the lumbar spine (<or= 3 non-evaluable lumbar vertebrae at lumbar spine L1 – L4) or the femoral neck;

    f) clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (>or= 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or >or= 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist;

    g) glucocorticoid-induced osteopenia;

    h) previous bisphosphonate therapy;

    i) use of estrogens and/or progestins for > 1 month at any time within the past 12 months;

    j) use of any of the following medications for > 1 month at any time within the past 6 months:
    -corticosteroids or anabolic medications,
    -vitamin D (>or= 1000 IU/day), or
    -diuretics or anticonvulsants;

    k) use of fluoride (prescribed in the bone therapeutic range of >or=10 mg/day) for > 1 month;

    l) current use of any of the following medications:
    -oral or parenteral glucocorticoids,
    -anabolic steroids,
    -estrogens (oral, skin patch, gel, or subcutaneous implant),
    -estrogen-related medications, such as tamoxifene, selective estrogen receptor modulators (raloxifene), tibolone
    -calcitonin, calcitriol, calcifediol, or alfacalcidol
    -calcium supplements (>500mg/day)
    -vitamin D supplements (>400 IU/day)
    -vitamin D depot injection (10,000 IU),
    -any bisphosphonate (other than the investigational product),
    -fluoride (>or=10 mg/day),
    -strontium and other bone active agents (ie isoflavones),
    -PTH; or
    -any other investigational product

    m) history of any allergic or abnormal reaction to bisphosphonates;

    n) severe renal impairment (creatinine clearance < 30mL/min);

    o) serum 25-hydroxy vitamin D level < 15 ng/mL;

    p) markedly abnormal clinical laboratory parameters at screening assessed as clinically significant by the investigator;

    q) participation in another clinical study 30 days prior to enrollment;

    r) demonstrated unlikely to comply with protocol requirements (eg, uncooperative attitude, inability to return for follow-up visits, history of medical non-compliance) and/or poor likelihood of completing the study.
    E.5 End points
    E.5.1Primary end point(s)
    3-D-pQCT Data—Microarchitectural Parameters (Distal Radius BV/TV Measurements):

    The primary efficacy assessment in this study will be BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12. If there is a history of prior fracture (traumatic or atraumatic) in the non dominant wrist, the dominant wrist will be used.

    Measurements will be taken using Xtreme CT scanners supplied by SCANCO Medical AG, (Bassersdorf, Switzerland) who will be responsible for the analysis and central reading of the radiological images. The standard procedures and analysis methods for 3D pQCT measurements are described in Appendix 4 of the protocol.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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. 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 No
    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) No
    E.8.2.2Placebo Yes
    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 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 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
    The study is considered terminated upon completion of all patient protocol-scheduled treatments and evaluations.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) No
    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 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 130
    F.4.2.2In the whole clinical trial 156
    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 Decision2006-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-22
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