Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00212667

Enrollment

650

Registered

2005-09-21

Start date

2002-08-31

Completion date

Unknown

Last updated

2012-10-11

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

Conditions

Involutional Osteoporosis

Keywords

ONO-5920, osteoporosis, bisphosphonate

Brief summary

The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.

Interventions

DRUGONO-5920

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis 2. Patients having radiographically confirmed vertebral (T4-L4) fractures 3. Other inclusion criteria as specified in the study protocol

Exclusion criteria

1. Patients having secondary osteoporosis or another condition that presents low bone mass 2. Patients having findings on X-ray that affect evaluation of vertebral fracture 3. Patients that have been administered bisphosphonate derivatives 4. Other

Design outcomes

Primary

Measure	Time frame
New fragility vertebral fracture	—

Secondary

Measure	Time frame
New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain	—

Outcome results

None listed

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