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NCT00794443 Clinical Trial

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

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
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