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Completed

NCT Number: NCT00212628

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

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

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Key information

Conditions

Involutional Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Chugoku Region Facility, Chugoku, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator
  • Patients having secondary osteoporosis or another condition that presents low bone mass
  • Other exclusion criteria as specified in the study protocol

Treatment and study plan

Minodronic acid hydrate

Drug

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.

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Astellas Pharma Inc

Registry information

Important dates

Study start
2004
First posted
Sep 21, 2005
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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