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    Summary
    EudraCT Number:2004-002317-37
    Sponsor's Protocol Code Number:HMR4003B/4034
    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:2004-11-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-002317-37
    A.3Full title of the trial
    OPEN-LABEL STUDY TO DETERMINE HOW PRIOR THERAPY WITH ALENDRONATE OR RISEDRONATE IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS INFLUENCES THE CLINICAL EFFECTIVENESS OF TERIPARATIDE
    A.3.2Name or abbreviated title of the trial where available
    OPTAMISE
    A.4.1Sponsor's protocol code numberHMR4003B/4034
    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 SponsorAventis Inc.
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Forsteo 20 micrograms/ 80 microlitres, solution for injection, in pre-filled pen
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.Grootslag 1-5NL 3991 RA HoutenThe Netherlands
    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 nameTeriparatide (human, recombinant PTH [1-34])
    D.3.2Product code not applicable
    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.3.8INN - Proposed INNTeriparatide (human, recombinant PTH [1-34])
    D.3.9.3Other descriptive nameTeriparatid rh PTH (1-34)
    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 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 Yes
    D.3.11.13.1Other medicinal product typehuman, recombinant, parathyroid hormone
    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
    Post-menopausal woman with 1 or more prevalent osteoporotic fractures and a BMD (spine or hip) of < -2.5 (see protocol amendment 2).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    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 the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change from baseline in P1NP, after 3 months of treatment, between subjects previously treated with risedronate and those previously treated with alendronate.
    E.2.2Secondary objectives of the trial
    Compare the teriparatide-associated change from baseline in P1NP, at additional time points,
    Compare the teriparatide-associated change from baseline in other markers of bone formation,
    Compare the teriparatide-associated change from baseline in markers of bone resorption.
    Compare the teriparatide-associated percent change from baseline in LS BMD as measured by DXA,
    Compare the teriparatide-associated percent change from baseline in total hip BMD as measured by DXA,
    Compare the teriparatide-associated percent change from baseline in forearm BMD as measured by DXA, between subjects previously treated with risedronate and those previously treated with alendronate.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    > Woman who have used risedronate or alendronate continuously for a minimum of 24 to 36 months up to enrollment into study.
    > Women who are at least 10 years post menopause (i.e., 10 years have elapsed since the last menstrual period).
    > 55-85 years of age (inclusive), if natural menopause, or 60-85 years of age (inclusive), if surgical menopause.
    > Must have appropriate documentation to confirm that subject has been on either continuous (i.e., uninterrupted) daily or weekly formulations of risedronate (5 mg once daily [OD] or 35 or 30 mg once a week [OAW]) or alendronate (10 mg OD or 70 mg OAW), for a minimum of 24 months up to enrollment into study.
    > LS or total hip BMD T-score less than or equal to -2.0 and a prevalent vertebral fracture, or LS or total hip BMD T-score less than or equal to -2.5. The qualifying values must have been documented prior to enrollment (amendment 2: LS or total hip BMD T-score less than -2.5 and a prevalent osteoporotic fracture).
    > Vitamin D replete (25-hydroxyvitamin more than or equal to 20 ng/ml and less than or equal to 80 ng/ml).
    > Urine NTX <50 nmol/mmol Creatinine (to assure treatment compliance and bone turnover is well into the pre-menopausal range).
    > At least 2 measurable lumbar spine vertebrae (i.e., without fracture or sufficient degenerative disease) in which bone density assessment can be made without interfere.
    E.4Principal exclusion criteria
    > Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
    > Any previous or ongoing illness that, in the opinion of the investigator, could prevent the subject from completing the study.
    > Impaired renal function, as shown by creatinine clearance of less than 30 ml/min.
    > Subjects with active or recent urolithiasis (within 5 years of the time of enrollment).
    > Any condition or disease that may interfere with the evaluation of at least 2 lumbar vertebrae (not necessarily contiguous), determined in a screening radiograph by a radiologist at the central facility (e.g., confluent aortic calcifications, severe osteoarthritis, spinal fusion, lumbar spine fractures).
    > History of untreated osteomalacia.
    > History of osteosarcoma.
    > Any condition that could predispose to the risk of osteosarcoma, including but not limited to Paget’s disease of bone, history of radiation therapy to the skeleton, or any metastatic skeletal disease.
    > History of cancer within the past 5 years, though subjects with a more recent history of relatively benign skin malignancies such as basal cell or squamous cell carcinoma are not excluded. Subjects with a more recent history of successfully treated cervical carcinoma in situ will not be excluded provided there is documented 12-month remission.
    > History of untreated hyperparathyroidism.
    > Uncorrected hypothyroidism or hyperthyroidism, as determined by clinical signs and symptoms and/or significantly abnormal lab values at screening. Although thyroid function studies are not required, should an abnormal TSH be detected, the subject may be enrolled, after consultation with the medical monitor, if other thyroid function tests are not significantly out of range and clinical manifestations of disease are not present. Subjects taking thyroid medication should be stabilized on an appropriate medication for 3 months prior to randomization.
    > Any abnormal laboratory parameters that are judged to be clinically significant.
    > History of unexplained elevated levels of alkaline phosphatase in the blood.
    > Hypocalcemia or hypercalcemia from any cause.
    > Depot injection Vitamin D >10,000 IU in the past 9 months prior to starting the investigational product.
    > Treatment with antiresorptive agents other than risedronate, alendronate, and hormone replacement therapy within the last 36 months before study entry (i.e., ibandronate, pamidronate, etidronate, raloxifene, clodronate, or zoledronate).
    > Use of any of the following medications within 6 months of starting the investigational product or any of the following medications for more than 14 days, within 1 year prior to starting the investigational product:
    - fluoride (more than or equal to 10 mg/day)
    - subcutaneous estrogen implant
    - hormone replacement therapy (estrogen and/or progesterin)
    - Estrogen (oral or skin patch) or estrogen-related drugs (e.g., tamoxifen, tibolone), except for low dose vaginal creams (less than or equal to 0.2 mg/day 17-β estradiol or less than or equal to 1.5 mg/day estropipate)
    - Progestogen
    > Use of any of the following medications within 3 months of starting the investigational product or any of the following medications for more than 1 month, within 6 months prior to starting the investigational product:
    - Oral or parenteral glucocorticoids (more than or equal to 5 mg prednisone or equivalent/day)
    - Anabolic steroids
    - Any other sources of steroid hormone replacement including herbal preparations.
    > Use of calcitonin, calcitriol, or calcifediol within 1 month of starting the investigational product or for more than 1 month within 6 months prior to starting the investigational product.
    > Use of combination alendronate and risedronate, either simultaneously or sequentially, within 36 months prior to enrollment.
    > Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see protocol section 6.2, Prior and Concomitant Treatments).
    > History of hypersensitivity to teriparatide (human, recombinant PTH[1-34]) or any of its excipients.
    > Treatment with any investigational product in the last 3 months before study entry.
    Participation in another clinical trial within 30 days prior to enrollment.
    > Unlikely to comply with protocol, e.g. uncooperative attitude, inability to return.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in P1NP between the subjects previously treated with risedronate and the subjects previously treated with alendronate.
    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 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 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
    End of study is defined as last patient out in all countries.
    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 months4
    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 months0
    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) 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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    postmenopausal women
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 290
    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)
    Teriparatide is available on the market. It is in the discretion of the investigator to decide whether he wants to continue the treatment or not after the end of the study.
    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 Decision2004-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-04-17
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    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
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