ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

692 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis Bone Loss, Age-Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. Monthly - Dose 1

Monthly intermittent administration, dose 1

Group Type EXPERIMENTAL

YM529 / ONO-5920

Intervention Type DRUG

Oral

2. Monthly - Dose 2

Monthly intermittent administration, dose 2

Group Type EXPERIMENTAL

YM529 / ONO-5920

Intervention Type DRUG

Oral

3. Daily

Daily administration

Group Type ACTIVE_COMPARATOR

YM529 / ONO-5920

Intervention Type DRUG

Oral

Interventions

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YM529 / ONO-5920

Oral

Intervention Type DRUG

Other Intervention Names

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YM529 ONO-5920 Minodronic acid

Eligibility Criteria

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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)

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No