ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

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.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00794443

Enrollment

692

Registered

2008-11-20

Start date

2008-11-30

Completion date

2010-04-30

Last updated

2015-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Age-Related, Osteoporosis

Keywords

ONO-5920, YM529, Bone mineral density, Minodronic acid

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.

Interventions

DRUGYM529 / ONO-5920

Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method	At the final evaluation point

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026