E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteopenic and Osteoporotic postmenopausal women |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 |
To determine the early (Week 1 to Week 4) bone formation and bone resorption biomarker response profiles of a bone anabolic treatment. |
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E.2.2 | Secondary objectives of the trial |
1) To describe the early bone formation biomarker response to a bone anabolic reference treatment. 2) To describe the early bone resorption biomarker response to a bone anabolic reference treatment. 3) To describe the early calcium metabolism biomarker response to a bone anabolic reference treatment. 4) To identify appropriate biomarkers for potential use as surrogates of positive bone response during the first weeks of treatment initiation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Female subjects more than 55 years of age inclusive. 2) Post menopausal status according to the following guidelines: -Cessation of menses for >5 years Or documented bilateral oophorectomy at least 1 year previously -Cessation of menses for <25 years -In women >55 and < 60 years of age, FSH level >30 IU/l (confirmed prior to dosing) 3) Diagnosis of osteoporosis or osteopenia with a Bone Mineral Density T score ≤ -1 at the Lumbar spine or total hip. 4) Normocalcemia Serum Calcium ≥2.0 mmol/l and ≤2.5mmol/l. 5) Vitamin D 25-(OH) Serum level of ≥ 15ng/ml. 6)Otherwise in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, standard laboratory tests and urinalysis at screening, and the opinion of the investigator. 7) Screening BMI must be >18.5 and ≤28 and subjects must weigh at least 50 kg to participate in this study. 8) At screening and baseline vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least 3 mins and again when required after 3 mins in the standing position. 9) Able to communicate well with the investigator to understand and comply with the requirements of the study. Understand and sign the written informed consent. |
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E.4 | Principal exclusion criteria |
1) Subjects who are using or have used in the past 12 months any of the following medications: strontium ranelate, bisphosphonate (no bisphosphonate use permitted in last 24 months), PTH, Oestrogens, HRT including SERMs, Calcitonin, aluminium supplements. 2) Subjects with a history of chronic use of systemic corticosteroids (oral or i.v.) within the last year where the total dose exceeds 750 mg of oral prednisone or equivalent: NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articular) more than one month prior to screening are NOT exclusionary. 3) Subjects who are using or have used in the past 3 months any of the following medications: Statins, Thiazide Diuretics, β-blockers, diphenylhydantoin or other anticonvulsants and heparin. 4) Subjects with cancer of history of malignancy of any organ system, treated or untreated, at anytime, whether or not there is evidence of local recurrence or metastases. Some exceptions described in the protocol will apply. 5) Subjects with any of the following: - a +ve HBsAg or Hep C test result. - history og immunodeficiency diseases, inclu a +ve HIV test result. - clinically significant abnornmal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin. - clinically significant abnormal creatinine or BUN values or abnormal urinary constituents. - evidence of urinary obstruction or difficultly in voiding at screening. 6) Patients with 25- (OH) Vit D levels less than 15 ng/mL prior to randomisation. 7) subjects with metabolic bone disease, such as paget's disease, crushing syndrome, acromegaly, osteogenesis imperfecta, or serious illness affecting normal bone homeostasis (by history and physical) 8) Subjects exhibing or with a history of any of the following signs and symptoms, - high caffeine intake, vertebral tenderness, surgical scar on neck suggestive of prior thyroid surgery, Rachitic rosary or any bone deformities suggestive or prior rickets, Cafe au lait spots, neuromuscualar irritability. 9) Subjects with measured abnormal safety laboratory values. 10) Subjects with anorexia nervosa, suspected bulemia, or obvious malnutrition. 11) History of drug or alcohol abuse within 12 months prior to dosing. 12) Smokers - more than 20 cigarettes per day used. 13) Subjects who have started Vit D or calcium supplements less than 1 month prior to screening. 14) Participation in any clinical investigation within 4 weeks prior to dosing or longer if required. 15) Blood donors or loss of 400ml or more of blood within 8weeks prior to screening. 16) Significant illness within 2 weeks prior to dosing. 17) History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated). 18) History of clinically significant drug allergy or hostory of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To Determine the Early (week 1 to Week 4) bone formation and bone resorption biomarker response profiles of a bone anabolic treatment |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | Information not present in EudraCT |
E.6.13.1 | Other scope of the trial description |
Biomarker Response Profile |
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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 | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | 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
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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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |