Postmenopausal osteoporosis Classification code 10031285
Conditions
Interventions
Product Name: Bonviva 150mg film-coated tablet
Product Code: RO200-5450
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ibandronic acid
Current Sponsor code: Ibandronat
Other descriptive
Sponsors
Center for Muscle and Bone Research of the Charité Universitaetsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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+ 2.6 mmol/l • Vitamin D deficiency (serum 25-hydroxy vitamin D 210 µmol/l) • Contra indications for ibandronate, calcium or vitamin D
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: • 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) ;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. | — |
Countries
Germany
Outcome results
None listed