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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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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    Summary
    EudraCT Number:2006-006064-32
    Sponsor's Protocol Code Number:FP-005-IM
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-006064-32
    A.3Full title of the trial
    A 24-week, international, multi centre, randomised, double-blind, double-dummy, parallel group, phase IV clinical trial investigating changes in back pain in postmenopausal women with an osteoporosis related vertebral fracture(s) treated with either 100 µg PTH(1-84) daily or 70 mg alendronate weekly
    A.3.2Name or abbreviated title of the trial where available
    RELIEF
    A.4.1Sponsor's protocol code numberFP-005-IM
    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 SponsorNycomed Danmark Aps
    B.1.3.4CountryDenmark
    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 Preotact
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed Danmark ApS
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namePreotact
    D.3.4Pharmaceutical form Powder and solvent for 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.3.8INN - Proposed INNparatyroid hormone (rDNA)
    D.3.9.1CAS number 68893-82-3
    D.3.9.3Other descriptive namePARATHYROID HORMONE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1,61
    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 Yes
    D.3.11.13.1Other medicinal product typeParathyroid hormone (rDNA)
    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 Fosamax once weekly 70 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Capsule*
    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 INNalendronic acid
    D.3.9.1CAS number 121268175
    D.3.9.3Other descriptive nameALENDRONATE SODIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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) Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typealendronate sodium
    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 placeboPowder and solvent for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    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
    Primary Postmenopausal Osteoporosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    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 is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity, over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).
    E.2.2Secondary objectives of the trial
    Secondary objective is to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral facture(s).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
    2. Is the subject at least 50 years of age?
    3. Has the subject been postmenopausal for more than 3 years – in the judgement of the investigator?
    4. Does the subject have a T-score ≤ -1.5 SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip or femoral neck (existing DXA scans up to 3 months old at the time of screening visit are accepted)
    5. Does the subject have an X-ray verified vertebral fracture (reduction > 25% in anterior, middle or posterior height compared to adjacent vertebra) defined by Genant semi quantitative visual grading? (existing X-rays up to 6 weeks old at the time of screening visit are accepted)
    6. Does the subject have chronic back pain which is considered to be related to one or more vertebral fractures (chronic pain is defined as 3 months with back pain likely to be caused by the vertebral fracture(s))?
    7. At the screening visit: does the subject assess the intensity of her back pain this morning before any use of analgesic medication to be 4 or more on the 11 point NRS.
    8. At the randomisation visit: is the average of the last 7 days back pain assessments 4 or more on the 11 points NRS (captured in the i-diary system)?
    9. Is the subject willing to fill in the subject diary system (using a toll-free number)every day for the whole trial period, and register the intensity of her back pain and number of falls ?
    10. Is (current) dosage and type of analgesic treatment of the subject considered to be stable and expected by the investigator to remain so within the next 6 months?
    11. Is the subject currently taking calcium and vitamin D3 or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcaemia or other drug related side effects?
    12. Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU) daily for at least 14 days (after the screening visit) before blood sampling for eligibility evaluation?
    13. Is the subject able to self-inject PTH(1-84), or have the injections with assistance from a helper?
    E.4Principal exclusion criteria
    Has the subject within the last 3 months been treated with:
    1. anti-resorptive treatment (e.g. bisphosphonates, calcitonin, HRT (hormone replacement therapy) or SERM (selective estrogen receptor modulator))?
    2. fluorides?
    3. strontium ranelate?
    4. teriparatide or PTH(1-84)? (previous treatment must not have exceeded 12 months in total)
    5. glucocorticosteroids? Local, topical and inhalation steroids are permitted.
    or has the subject been treated:
    6. with any intravenous (iv.) bisphosphonates within the last 12 months
    7. for cancer (other than basocellular skin cancer) within the last 5 years?
    8. with radiation therapy to the skeleton ever?
    or has the subject ever been diagnosed with:
    9. any malignant disease affecting the skeleton?
    10. spondylolisthesis, intervertebral disc herniation, spinal stenosis or another spinal disease that can cause the back pain?
    11. any clinically significant diseases affecting calcium metabolism?
    12. any metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism, Paget’s disease, osteogenesis imperfecta, or osteomalacia)?
    13. fibromyalgia
    14. upper gastro-intestinal problems such as dysphagia, gastritis, duodenitis, ulcers or a recent history (within the last year) of major gastrointestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or had surgery of the upper gastro-intestinal tract other than pyloroplasty?
    15. abnormalities of the oesophagus or other factors which delay oesophageal emptying such as stricture or achalasia
    16. or has a known history of hypersensitivity to parathyroid hormone or alendronate or any of the excipients in the IMP or dispensed supplements?
    or is the subject:
    17. currently receiving or intending to start (within the trial period) any non-pharmacological treatment i.e. physical and/or psychological therapies that can modulate the perception of pain? –according to the investigator’s opinion.
    18. taking any other medication (apart from calcium and vitamin D3) that is known to affect bone metabolism? – according to the investigator’s opinion.
    19. taking cardiac glucosides?
    20. scheduled for any spinal surgery (e.g. kyphoplasty or vertebroplasty) within the trial period?
    21. having problems standing or sitting upright for at least 30 minutes?
    22. currently participating or intend to participate within the trial period in another clinical trial with an investigational medical product? She must not have participated in such trials within the last 90 days. Previous and current participation in non-interventional trials is allowed.
    Exclusion criteria 23 to 29 must be evaluated before randomisation
    Answers must be based on clinical judgement and the result of the blood analysis performed at the lab visit, after at least 14 days of calcium and vitamin D3 intake in the screening period

    After a minimum of 14 days intake of calcium/vitamin D3, does the subject have:
    23. a serum vitamin D3, (serum 25(OH)D) level <20 ng/ml?
    24. a serum PTH of > 65 pg/ml and also a total serum calcium value >2.49 mmol/l?
    25. hypercalcaemia (total serum calcium value >2.55 mmol/l)?
    26. hypocalcaemia? Defined as s-calcium below lower normal limit.
    27. impaired kidney function with creatinine clearance < 35 ml/min (indirect measurement by serum creatinine) or current kidney stones?
    28. elevated serum alkaline phosphatase? Defined as > 1.5 X ULN 1
    29. severely impaired liver function? - according to the investigators opinion
    E.5 End points
    E.5.1Primary end point(s)
    • Change in back pain intensity during 24 weeks of treatment, using a numerical rating scale (NRS)
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA40
    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
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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 Decision2008-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-06
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