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A Phase 2, Multicenter, Randomized, Active-Controlled, Parallel-Group, Dose-Finding and Safety Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) in Subje...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-007456-34

A Phase 2, Multicenter, Randomized, Active-Controlled, Parallel-Group, Dose-Finding and Safety Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) in Subjects With Decreased Bone Mineral Density

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Extrait

The primary objective of this study is to show increased BMD of the proximal femur (total hip BMD) after injection of rhBMP-2/CPM (either 1.0 mg/mL or 2.0 mg/mL) as an adjunct to systemic osteoporosis therapy. To assess the primary objective, BMD will be measured by dual-energy x-ray absorptiometry (DXA) every 3 months from 6 to 12 months.

Critère d'inclusion

  • Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture,Subjects with decreased Bone Mineral Density (BMD) at risk for hip fractures is the medical condition being investigated

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