Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-019758-42
    Sponsor's Protocol Code Number:I2M-MC-GSDB
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-06
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2010-019758-42
    A.3Full title of the trial
    A Phase 2 Randomized Study of LY2541546 Versus Placebo in Postmenopausal Women with Low Bone Mineral Density: An Evaluation of the Dose Response Relationship using Bone Mineral Density
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of LY2541546 in Women with Low Bone Mineral Density

    A.3.2Name or abbreviated title of the trial where available
    GSDB
    A.4.1Sponsor's protocol code numberI2M-MC-GSDB
    A.7Trial is part of a Paediatric Investigation Plan No
    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 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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address.NA
    B.5.3.2Town/ city.NA
    B.5.3.3Post code.NA
    B.5.4Telephone number.NA...
    B.5.5Fax number.NA...
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    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.2.1.1.1Trade name .
    D.2.1.1.2Name of the Marketing Authorisation holder.
    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 nameLY2541546
    D.3.2Product code LY2541546
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLY2541546
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number48
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoporosis
    E.1.1.1Medical condition in easily understood language
    Osteoporosis - a condition with low bone mineral density
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10031282
    E.1.2Term Osteoporosis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 dose response of LY2541546 using BMD change from baseline, measured by dual energy x-ray absorptiometry (DXA) of the lumbar spine at 52 weeks, compared with placebo in PMP women with low BMD.
    E.2.2Secondary objectives of the trial
    - To evaluate the overall safety and tolerability of LY2541546 following multiple subcutaneous (SC) administrations.
    - To evaluate dose(s) of LY2541546 that increase BMD from baseline, measured by DXA of the lumbar spine at 12 and 24 weeks, compared with placebo.
    - To evaluate dose(s) of LY2541546 that increase BMD from baseline, measured by DXA of the proximal femur and wrist, compared with placebo.
    - To evaluate the dose effect of LY2541546 on biochemical markers of bone metabolism, including bone-specific alkaline phosphatase (BSAP), serum type I collagen fragment (CTx), osteocalcin, and serum N-terminal extension propeptide of type I collagen (P1NP).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol Addendum I2M-MC-GSDB(1), 03-June-2010
    A Phase 2 Randomized Study of LY2541546 Versus Placebo in Postmenopausal Women with Low Bone Mineral Density: An Evaluation of the Dose Response Relationship using Bone Mineral Density
    •To evaluate bone quality using quantitative computed tomography (QCT) scans of the hip and spine

    Addendum(3) only in Estonia.

    Protocol Addendum I2M-MC-GSDB(4) rev 1. 4-April-2011
    Addendum to extend follow-up period to allow a longer period of observation for adverse events and provide much greater detail of the changes in bone mineral density (BMD) that occur after stopping therapy.
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] Ambulatory, postmenopausal women between 45 and 85 years of age, inclusive. Postmenopausal is defined as:
    - At least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy (confirmed by operative note if without hysterectomy) or,
    - Spontaneous amenorrhea, that is not induced by a medical condition such as anorexia nervosa or by medications (such as oral contraceptives, hormones, gonadotropin-releasing hormone [GnRH], anti-estrogens, selective
    estrogen receptor modulator [SERMs], chemotherapy), for at least 12 months, or for at least 6 months with a serum follicle-stimulating hormone (FSH) level >40 mIU/mL and a negative pregnancy test, or,
    - Hysterectomy prior to menopause and at least 2 years prior to randomization; if ≤60 years old, both serum estradiol level <73 pmol/L (20 pg/mL) and FSH level >30 mIU/mL.
    [2] Have low BMD, defined as a T-score for lumbar spine of between –3.5 and -2.0, inclusive, based on the local DXA report as interpreted by the investigator. The method of determining T-score values will be based on regional standards. Three of 4 vertebrae, L1 through L4, must be evaluable for BMD scoring, as measured by DXA.
    [3] Without language barrier, reliable, and willing to make themselves available for the duration of the study and to follow study procedures.
    [4] Willing to receive study drug and take daily supplements (calcium and Vitamin D).
    [5] Normal laboratory tests or laboratory test results determined not clinically significant by the investigator. Serum phosphate and serum calcium must be within normal limits.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    [6] Are investigator site personnel directly affiliated with this study and/or their immediate families.
    [7] Are Lilly employees.
    [8] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
    [9] Have previously completed or withdrawn from this study or any other study investigating LY2541546.
    [10] Have received treatment with any of the following medications more recently than 3 months prior to screening:androgen, Calcitonin, SERMs, Tibolone
    [11] Recent initiation of hormone replacement therapy.
    [12] Have previously used or currently use denosumab, parathyroid hormone (PTH) and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
    [13] Have received treatment with any oral bisphosphonate within the last year or within the last 3 years. The patient may be enrolled if, as assessed by the investigator, she has taken clinically insignificant amounts of oral bisphosphonate.
    [14] Have received therapeutic doses of systemic corticosteroids for more than 1 month during the 6 months prior to screening.
    [15] Have received therapeutic doses of fluorides (20 mg/day) for more than 3 months during the last 3 years, or for more than a total of 2 years, or any within the last 6 months.
    [16] Have severe Vitamin D deficiency defined as 25-hydroxyvitamin D less than <10 ng/mL (25 nmol/L) at the screening visit.
    [17] Have any known bone disorder other than low BMD or osteoporosis.
    [18] Have a history of osteoporotic fractures, such as a fracture occurring during the menopausal years, but also including known prevalent vertebral fracture or evidence of prevalent vertebral fracture on screening spine X-ray or DXA. In addition, if the patient is considered to have a high risk for fracture as assessed by the investigator, based for example on age and T-score, they should be excluded.
    [19] Have a history of Bell's palsy, other cranial nerve damage, or have a history of a temporomandibular joint disorder (TMJD).
    [20] Have any history of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
    [21] In the opinion of the investigator, the patient represents an unacceptable medical or psychiatric risk for treatment with an investigational drug.
    [22] Have known allergy to LY2541546, any of the diluents or excipients of LY2541546, or significant allergy to any other monoclonal antibody
    [23] History of excessive consumption of alcohol or abuse of drugs within the last year, as assessed by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline to endpoint (52 weeks) in BMD of the lumbar spine measured by DXA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    E.5.2Secondary end point(s)
    Change from baseline to 12, 24, and 64 weeks in lumbar spine bone mineral density (BMD)

    Change from baseline to 24, 52 and 64 weeks in proximal femur bone mineral density (BMD)

    Change from baseline to 52 week endpoint in proximal femur and wrist bone mineral density (BMD)

    Change from baseline to 52 week endpoint in Bone-specific alkaline phosphatase (BSAP)

    Change from baseline to 52 week endpoint in Serum type I collagen fragment (CTx)

    Change from baseline to 52 week endpoint in Osteocalcin

    Change from baseline to 52 week endpoint in Serum N-terminal extension propeptide of type I collagen (P1NP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12, 24, 52 and 64 weeks as described above
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 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.8.2.4Number of treatment arms in the trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Denmark
    Estonia
    Lithuania
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    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 months21
    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 months21
    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.1.1Number of subjects for this age range: 0
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 153
    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)
    Follow up treatment will be at the discretion of the investigator and patient. The patients enrolling in this trial will likely only be mildly osteoporotic.
    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 Decision2010-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-22
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 22:19:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA