E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031282 |
E.1.2 | Term | Osteoporosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. What is the effect of teriparatide on the axial and appendicular skeleton and on cortical and trabecular bone as assessed by QCT? 2. What are the time course and the magnitude of effect of teriparatide on biochemical markers of bone turnover?
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E.2.2 | Secondary objectives of the trial |
1. Does the 12 week HR-pQCT response to teriparatide predict the BMD response at 104 weeks? 2. Do the early changes in biochemical markers of bone turnover predict the BMD response to teriparatide at 52 and 104 weeks? |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: Bone histomorphometry sub study The aim of this sub-study is to examine the anabolic mechanism of teriparatide at tissue level using bone histomorphometry techniques. This is an optional procedure, with a separate informed consent procedure. A bone biopsy sample will be taken on a single occasion, approximately 7 weeks after starting teriparatide therapy. |
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E.3 | Principal inclusion criteria |
Subjects must: - Have a BMD T-score (at the lumbar spine or total hip) of less than or equal to -2.5 - Be female - Be at least 5 years post menopausal (more than 5 years since their last menstrual period) but <85 years old. - Be ambulatory - Be able and willing to participate in the study and provide written informed consent - Have a serum 25 (OH)2 vitamin D3 >50 nmol/L (after vitamin D3 loading) |
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E.4 | Principal exclusion criteria |
Patients will not be admitted to the study if they exhibit any of the following: - Evidence of a clinically significant organic disease which could prevent the patient from completing the study - A BMI less than 18 or greater than 35 - Abuse of alcohol or use illicit drugs (information obtained from medical history) or who consumed more than 4 servings of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers) - Any history of cancer within the past 5 years excluding skin cancer non melanomas - Any history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health including Paget’s disease of bone - Chronic renal disease (as defined by an estimated glomerular filtration rate of ≤ 30mL/min) - Acute or chronic hepatic disease - Malabsorption syndromes - Hyperthyroidism as manifested by TSH outside the lower limit of the normal range - Hyperparathyroidism - Hypocalcemia or hypercalcemia - Osteomalacia - Cushing’s syndrome - Current use of glucocorticoid therapy - A corrected serum calcium less than 2.2 mmol/L and a PTH above 100ng/L (that persists after testing and treatment for vitamin D deficiency) - A history of any known condition that would interfere with the assessment of DXA at either lumbar spine or femoral neck - Markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator - Any previous use of bisphosphonate - Use any of the following medications within 12 months of starting study drug - Any fluoride with the exception of use for oral hygiene - Strontium Ranelate - Other bone agents (e.g. SERM, isoflavones, HRT) - Participation in another clinical trial involving active therapy 3 months prior to enrolment - Less than 5 years since menopause - Bilateral fractures in the measurement regions (hip, tibia and forearm). - Recent fracture within the last 12 months - Prior radiation therapy which may involve the skeleton - Hypersensitivity to teriparatide or any of its exipients - Unexplained elevations of alkaline phosphatase - Any known contraindication to the use of teriparatide. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in volumetric BMD of the spine by QCT (vertebrae L1-3) at 104 weeks. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial 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
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To avoid drifts or shifts in measurements, laboratory analysis will be completed all together once all study visits have been completed and all samples have been collected. To ensure that all sample analysis is completed satisfactorily before end-of-study is declared, we will consider the trial complete when all patients have completed their visits, all laboratory analyses have been performed, the data entered into a database and checked (i.e. database lock) and research papers published. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |