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    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-016523-61
    Sponsor's Protocol Code Number:PJMR0062105
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-016523-61
    A.3Full title of the trial
    18F-fluoride PET for Early Non-invasive Assessment of Cortical Bone Formation
    A.3.2Name or abbreviated title of the trial where available
    Non-invasive Assessment of Cortical Bone Formation - Version 1
    A.4.1Sponsor's protocol code numberPJMR0062105
    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 SponsorKing’s College London
    B.1.3.4CountryUnited Kingdom
    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
    B.Sponsor: 2
    B.1.1Name of SponsorGuy's & St Thomas NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 Teriparatide (Forsteo)
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
    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 nameTeriparatide
    D.3.4Pharmaceutical form 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 INNrecombinant human parathyroid hormone (1-34)
    D.3.9.1CAS number 52232-67-4
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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 Adcal-D3 chewable tablets
    D.2.1.1.2Name of the Marketing Authorisation holderProStrakan 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.3.1Product nameAdcal-D3 Chewable tablets
    D.3.4Pharmaceutical form Chewable 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 INNCalcium carbonate
    D.3.9.1CAS number 471-34-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNColecalciferol
    D.3.9.1CAS number 67-97-0
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Yes
    D.3.11.13.1Other medicinal product typeCalcium and Vitamin D3
    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
    Osteopenia
    Please note this is not a study to investigate the use of the IMP for the treatment of osteopenia but rather to validate a non-invasive imaging technique for measuring early changes in bone in response to therapy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10049088
    E.1.2Term Osteopenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to investigate if 18F-fluoride PET can be used to assess the direct effects of treatment on bone turnover at the hip.

    The primary objective is to compare changes in bone turnover at the hip measured by 18F-fluoride PET in postmenopausal women treated with teriparatide and untreated controls.
    E.2.2Secondary objectives of the trial
    To compare changes in bone turnover at the hip with changes at the lumbar spine in response to teriparatide treatment.

    To compare changes in bone turnover at the spine and hip with changes in biochemical markers of bone turnover and changes in bone mineral density.

    To examine test-retest variability of 18F-fluoride PET measurements at the hip.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will be eligible for entry into the study if they meet all the following inclusion criterion:
    • Ambulatory postmenopausal* women.
    • Aged 50 to 85 years inclusive.
    • Free of severe or chronically disabling condition.
    • Without language barrier, cooperative, expected to return for all follow-up visits and who give written informed consent before entering the study.
    • Lumbar spine, femoral neck and/or total hip BMD between 1 and 2.5 standard deviations below the average bone mineral density for young healthy women (i.e. T-score ≤-1 to > -2.5) as determined from the manufacturer’s database.
    • Normal or clinically insignificant abnormal laboratory values.
    • Normocalcemia Serum Calcium ≥2.15 mmol/l and ≤2.55 mmol/l.
    • Vitamin D 25-(OH) Serum level of ≥15 ng/ml (37.4 nmol/L)
    • Otherwise in good health as determined by past medical history, physical examination, vital signs, standard laboratory tests and urinalysis at screening and the opinion of the investigator.
    • Screening BMI must be >18.5 and ≤30 and subjects must weigh at least 50 kg.
    • At Screening vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least three (3) minutes, and again if clinically indicated after three (3) minutes in standing position. Vital signs should be within the following ranges:
    o Tympanic (ear) temperature between 35.5 – 37.5 °C
    o Systolic blood pressure, 90 – 160 mm Hg
    o Diastolic blood pressure, 50 – 90 mm HG
    o Pulse rate, 55 – 90 bpm
    When blood pressure and pulse will be taken again after 3 minutes standing, there shall be no more than a 20 mm Hg drop in systolic or 10 mm Hg drop in diastolic blood pressure and increase in heart rate (>20 bpm) associated with clinical manifestation of postural hypotension.
    All blood pressure measurements at other time-points should be assessed with the subject seated, unless stated otherwise in the protocol design, and utilizing the same arm for each determination.
    • Ability to lie still in a PET scanner for 70 minutes

    Definitions:
    * Postmenopausal status is defined as:
    • no vaginal bleeding for at least 12-months prior to enrolment in women with an intact uterus or
    • a hysterectomy and/or bilateral oophorectomy 12-months after a naturally occurring menopause or
    • a hysterectomy and/or bilateral oophorectomy prior to menopause and at least 12-months prior to enrolment with postmenopausal status defined biochemically by oestradial <73 pmol/L and FSH > 30 IU/L (confirmed prior to dosing).
    • In women >50 and <60 years of age, FSH level > 30 IU/l (confirmed prior to dosing)
    E.4Principal exclusion criteria
    Subjects will be excluded from the study if they meet any of the following criteria:

    • Current or recent (within 1 year of enrolment) metabolic bone disorders such as Paget’s disease of bone, Cushing’s Syndrome, acromegaly, osteogenesis imperfecta, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis and/or bone loss, or serious illness affecting normal bone homeostasis.
    • Current or recent (within 1 year of enrolment) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
    • Subjects with a history of hypothyroidism not on stable replacement therapy with levothyroxine (defined as no change of dose for at least 6-months prior to enrolment)
    • Subjects with skeletal malignancies or bone metastases
    • Recent (within 6-months of enrolment) fracture at any skeletal site.
    • Significant osteoarthritis of the lumbar spine and/or hip(s) precluding a satisfactory DXA or 18F-fluoride PET scan.
    • History of carcinoma in the previous 5 years or currently suspected carcinoma, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
    • Current or recent (within 1 year of enrolment) inflammatory bowel disease or malabsorption syndrome.
    • Pre-existing hypercalcaemia
    • Unexplained elevations of alkaline phosphatase.
    • Current or recent (within 2 years of enrolment) nephrolithiasis or urolithiasis.
    • Clinically significant renal, pancreatic, hepatic or cardiovascular disease, diabetes requiring pharmacotherapy indicated by:
    o Clinically significant abnormal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin
    o Clinically significantly abnormal creatinine or BUN values or abnormal urinary constituents (e.g. albuminuria)
    o Evidence of urinary obstruction or difficulty in voiding at screening
    • History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory tests conducted at screening.
    • Current or recent treatment (within 1 year of enrolment) with androgens or other anabolic steroids.
    • Current or recent (within 1 year of enrolment) treatment with oestrogens (with or without progestins) or selective oestrogen receptor modulators (SERMs)
    • Current or recent (within 1 year of enrolment) treatment with systemic corticosteroids, or orally inhaled or nasally inhaled corticosteroids in doses > 400 µg/day beclomethasone/day or equivalent.
    • Current or previous treatment with IV or oral bisphosphonates, strontium ranelate, fluorides, calcitonin, teriparatide or PTH 1-84, aluminium supplements.
    • Patients with 25-(OH) Vitamin D levels less than 15 ng/mL (37.4 nmol/L) prior to randomization
    • Treatment with vitamin D or calcium supplements started less than one month prior to screening visit.
    • Current or recent (within 1 year of enrolment) treatment with anticonvulsants.
    • Subjects with a positive Hepatitis B surface antigen (HBsAg) or hepatitis C test result or a history of immunodeficiency diseases, including a positive HIV test result.
    • Hypersensitivity to teriparatide or to any of the excipients.
    • Prior external beam or implant radiation therapy to the skeleton.
    • Poor medical or psychiatric risk for treatment in the opinion of the investigator.
    • Subjects with anorexia nervosa, suspected bulimia (by history or physical) or obvious malnutrition
    • Subjects exhibiting or with a history of any of the following signs or symptoms:
    o High caffeine intake (more than 8 cups of coffee per day, or equivalent)
    o Vertebral tenderness
    o Surgical scar on neck suggestive of prior thyroid surgery
    o Rachitic rosary or any bony deformities suggestive or prior rickets
    o Café au lait spots (suggestive of McCune-Albright syndrome)
    o Neuromuscular irritability (hypocalcemia)
    • Smokers who report cigarette use of more than 20 cigarettes per day.
    • Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
    • Donation or loss of 400 ml or more of blood within 8 weeks prior to screening, or longer if required by local regulation.
    Plasma donation within 7 days prior to first dosing. Hemoglobin levels below 12.0 g/dl at screening.
    • Significant illness within two weeks prior to dosing.
    • History of acute or chronic bronchospastic disease (including chronic obstructive pulmonary disease, treated or not treated)
    • History of clinically significant drug allergy or history of atopic allergy (urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.

    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to demonstrate a significant increase in the rate of bone formation, measured by 18F-fluoride PET, in the hip following 12-weeks of treatment with the anabolic agent teriparatide as compared to controls.
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No treatment
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    The end of the study is defined as the date that the last subject enrolled has their last study visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 months9
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Following the bone density (DXA) scan performed at the final study visit we will discuss with the patient any treatment for their bones if it is required. Postmenopausal women with osteopenia rather than osteoporosis do not routinely receive treatment in clinical practice. If treatment is appropriate, teriparatide will not be available to these participants as UK NICE guidelines state that this treatment can only be used in patients with severe osteoporosis (due to cost of teriparatide versus
    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 Decision2009-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-15
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