CompletedPhase 3

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

650 participantsStarted 2002-08

Plain-language summary

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

Age range55 Years – 80 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Patients having secondary osteoporosis or another condition that presents low bone mass
✕. Patients having findings on X-ray that affect evaluation of vertebral fracture
✕. Patients that have been administered bisphosphonate derivatives
✕. Other exclusion criteria as specified in the study protocol

New fragility vertebral fracture

NCT IDNCT00212667

SponsorOno Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-09