ClinicalTrials.gg
CompletedNCT00212628Updated Jun 14, 2012

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

A Phase 3 interventional study of Minodronic acid hydrate in Involutional Osteoporosis, sponsored by Ono Pharmaceutical Co., Ltd.. Completed at 9 sites in Japan. Open to female participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-06-14.

Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
444
Allocation
Non-randomized
Ages
55 Years to 80 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Involutional Osteoporosis

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Keywords

  • ONO-5920
  • osteoporosis
  • bisphosphonate
03

In context

Osteoporosis

1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.

This study's enrollment of 444 is above the median of 95 across 1,152 interventional studies indexed under Osteoporosis.

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Lead sponsor

Ono Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 exclusion criteria as specified in the study protocol
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
444 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. New fragility vertebral fracture

Secondary outcomes

  1. New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), lower back pain.

07

Study locations

9 sites
  • Chugoku Region Facility
    Chugoku, Japan
  • Chubu Region Facility
    Chūbu, Japan
  • Hokkaido Region Facility
    Hokkaido, Japan
  • Hokuriku Region Facility
    Hokuriku, Japan
  • Kanto Region Facility
    Kanto, Japan
  • Kinki Region Facility
    Kinki, Japan
  • Kyushu Region Facility
    Kyushu, Japan
  • Shikoku Region Facility
    Shikoku Region Facility, Japan
  • Tohoku Region Facility
    Tōhoku, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00212628
Collaborators
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
Jun 2004
Last update
Jun 14, 2012

Study contacts

Project Leader, Development Planning
study director · Ono Pharmaceutical Co., Ltd.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: YM 529

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