ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

Phase 2

Completed

• Conditions: Bone Loss, Age-Related; Osteoporosis
• Interventions: Drug: YM529 / ONO-5920

• Registration Number: NCT00794443
• Lead Sponsor: Astellas Pharma Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-18
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-20
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 692

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3. Daily	YM529 / ONO-5920	Daily administration
1. Monthly - Dose 1	YM529 / ONO-5920	Monthly intermittent administration, dose 1
2. Monthly - Dose 2	YM529 / ONO-5920	Monthly intermittent administration, dose 2

Primary Outcome Measures

Name	Time	Method
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method	At the final evaluation point

Secondary Outcome Measures

Name	Time	Method
Frequency of fracture	At the final evaluation point
Time-course changes in the total femoral bone mineral density by the DXA method	Through the treatment period
Assessment of adverse events, lab test values	Through the treatment period
Time-course changes in the percent change of bone metabolism markers	Through the treatment period