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

NCT00212628

Enrollment

444

Registered

2005-09-21

Start date

2004-06-30

Completion date

Unknown

Last updated

2012-06-14

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

DRUGMinodronic acid hydrate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Patients who was included in study ONO-5920-02 and completed the medication for two years 2. Other inclusion criteria as specified in the study protocol

Exclusion criteria

1. Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator 2. Patients having secondary osteoporosis or another condition that presents low bone mass 3. 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 spine (L2-4 BMD), lower back pain.	—

Countries

Japan

Outcome results

None listed

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