E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postmenopausal osteoporosis |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10031285 |
|
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 investigate changes of structural bone properties in vivo using 3DpQCT („Xtreme” CT, Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis; Structural and material properties determine bone strength. Using 3DpQCT you can measure one of the determinants of bone strength and predict fracture risk earlier and more precise, based on analyses of mechanical properties of bone. |
|
E.2.2 | Secondary objectives of the trial |
• Intra-individual changes after 12 months of therapy with ibandronate compared to placebo in: • 3DpQCT radius BV/TV • 3DpQCT radius trabecular bone separation (Tb.Sp) • Other 3DpQCT parameters of bone microarchitecture at distal radius and tibia: Trabecular number (Tb.N) Trabecular bone thickness (Tb.Th) Density measurements (cortical and trabecular regions) Cortical thickness Marrow star volume (MAStVol) Degree of Anisotrophy • 3D-reconstruction and –visualization of cortical and trabecular regions • Bone markers (sCTX and BAP) • Safety parameters (AE/SAE and safety lab)
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Age between 60 and 75 years • Menopause > 5 years • Measurable BMD of the spine and hip by DXA (e.g. no metal devices or severe degenerative changes) • BMD of spine (L1 – L4) or hip ≤ -2.0 and > -3.5 SD T-score measured by DXA • Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration • Written informed consent • 3DpQCT measurable at both skeletal sites, distal tibia and radius
|
|
E.4 | Principal exclusion criteria |
• spine or hip BMD ≤ -3,5 SD T-Score measured by DXA • Vertebral fractures • Multiple (>2) low trauma peripheral fractures • Employees of the Centre of Muscle and Bone Research, or their relatives
Medical history • Disease/disorder known to influence bone metabolism: chronic gastrointestinal or liver disease, chronic alcoholism, severe malabsorption syndrome, primary hyperpara-thyroidism, Paget's disease of bone, histologically documented osteomalacia, or documented active thyroid disease without treatment • History of major upper gastro-intestinal (GI) disease • Diagnosed malignant disease within the previous 10 years (except successfully resected basal cell cancer)
Previous medication • Previous treatment with a bisphoshonate at any time • Treatment with fluoride for osteoporosis (dose greater than 10 mg/day) within the last 12 months, or for more than 2 years (total duration) • Treatment with PTH and similar agents or strontium ranelate at any time • Treatment with other drugs affecting bone metabolism within the last 6 months Chronic systemic corticosteroid treatment estrogens, progestins, SERMs, anabolic steroids, active Vit. D analogs/metabolites, calcitonin) Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate
Laboratory • Serum total Ca 2+ < 2.2 mmol/l or > 2.6 mmol/l • Vitamin D deficiency (serum 25-hydroxy vitamin D < 12 ng/ ml • ALT above triple upper limit of normal range • Renal impairment (serum creatinine > 210 µmol/l) • Contra indications for ibandronate, calcium or vitamin D
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Intra-individual changes in fraction of bone volume per total sample volume (BV/TV) and intra-individual changes of trabecular bone separation at the distal tibia – measured by 3D pQCT – after 12 months of therapy with ibandronate compared to placebo. |
|
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 | Yes |
E.6.5 | Efficacy | Yes |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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.8.5 | 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 | 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
|
|
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 | 20 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 20 |