ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients - Full Text View

Sponsors and Collaborators:	Astellas Pharma Inc Ono Pharma
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00794443

Purpose

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.

Condition	Intervention	Phase
Osteoporosis Bone Loss, Age-Related	Drug: YM529 / ONO-5920	Phase II Phase III

MedlinePlus related topics: Minerals Osteoporosis

Drug Information available for: YM 529

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method [ Time Frame: At the final evaluation point ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time-course changes in the percent change of bone metabolism markers [ Time Frame: Through the treatment period ] [ Designated as safety issue: No ]
Time-course changes in the total femoral bone mineral density by the DXA method [ Time Frame: Through the treatment period ] [ Designated as safety issue: No ]
Assessment of adverse events, lab test values [ Time Frame: Through the treatment period ] [ Designated as safety issue: No ]
Frequency of fracture [ Time Frame: At the final evaluation point ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	November 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Monthly - Dose 1: Experimental Monthly intermittent administration, dose 1	Drug: YM529 / ONO-5920 Oral
2. Monthly - Dose 2: Experimental Monthly intermittent administration, dose 2	Drug: YM529 / ONO-5920 Oral
3. Daily: Active Comparator Daily administration	Drug: YM529 / ONO-5920 Oral

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794443

Contacts

Contact: Kinya Morimoto		km.morimoto@ono.co.jp
Contact: Clinical Development Administration Dept.		clinicaltrials_info@jp.astellas.com

Locations

Japan
	Recruiting
Hokkaido, Japan
	Recruiting
Kantou, Japan
	Recruiting
Kansai, Japan
	Recruiting
Shikoku, Japan
	Recruiting
Kyusyu, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Ono Pharma

Investigators

Study Director:	Toshiomi Minamide	Ono Pharma
Study Chair:	Central Contact	Clinical Development Administration Dept., Astellas Pharma Inc.

More Information

Responsible Party:	Astellas Pharma Inc. ( Director )
Study ID Numbers:	529-CL-028, ONO-5920-05
Study First Received:	November 18, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00794443
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

ONO-5920
YM529
Bone mineral density
Minodronic acid

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 14, 2009