ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

Osteoporosis Clinical Trial

Official title:

A Multi-center Double-blind Parallel-group Comparison Study in Involutional Osteoporosis Patients to Examine the Efficacy and Safety of ONO-5920/YM529 Monthly Intermittent Formulation With Its Daily Formulation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794443
• Other study ID #: 529-CL-028
• Secondary ID: ONO-5920-05
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 18, 2008
• Last updated: April 30, 2015
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: April 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Loss, Age-Related
• Osteoporosis

Intervention

Drug:
• YM529 / ONO-5920
Oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method		At the final evaluation point	No
Secondary	Time-course changes in the percent change of bone metabolism markers		Through the treatment period	No
Secondary	Time-course changes in the total femoral bone mineral density by the DXA method		Through the treatment period	No
Secondary	Assessment of adverse events, lab test values		Through the treatment period	No
Secondary	Frequency of fracture		At the final evaluation point	No

External Links

•   Link to Results on JAPIC - enter 150712 in the JapicCTI-RNo. field (Japanese record)