ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Diphosphonates

Criteria

Inclusion Criteria:

• Patients whose bone mineral density is <70% of Young Adult Mean (YAM), or <80% of YAM who have fragile fracture history

• Patients can walk on his/her own

• Written informed consent has been obtained from the patient.

Exclusion Criteria:

• Sequential osteoporosis patients or patients with other disorders showing low bone mass

• Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method

• Patients who are unable to keep raising or standing for ≥30 min

• Patients with peptic ulcer

• Patients who have experienced anamnesis or gastrectomy (total extraction)