NCT00794443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
692

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

Enrollment Period

1.4 years

First QC Date

November 18, 2008

Last Update Submit

April 30, 2015

Conditions

OsteoporosisBone Loss, Age-Related

Keywords

ONO-5920YM529Bone mineral densityMinodronic acid

Outcome Measures

Primary Outcomes (1)

  • Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method

    At the final evaluation point

Secondary Outcomes (4)

  • Time-course changes in the percent change of bone metabolism markers

    Through the treatment period

  • 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

  • Frequency of fracture

    At the final evaluation point

Study Arms (3)

1. Monthly - Dose 1

EXPERIMENTAL

Monthly intermittent administration, dose 1

Drug: YM529 / ONO-5920

2. Monthly - Dose 2

EXPERIMENTAL

Monthly intermittent administration, dose 2

Drug: YM529 / ONO-5920

3. Daily

ACTIVE COMPARATOR

Daily administration

Drug: YM529 / ONO-5920

Interventions

YM529 / ONO-5920DRUG

Oral

Also known as: YM529, ONO-5920, Minodronic acid
1. Monthly - Dose 12. Monthly - Dose 23. Daily

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

YM 529

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Toshiomi Minamide

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

  • Central Contact

    Clinical Development Administration Dept., Astellas Pharma Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2008

First Posted

November 20, 2008

Study Start

November 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 4, 2015

Record last verified: 2015-04

Locations

JP(5)