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Completed

NCT Number: NCT00212719

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

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
  • Other inclusion criteria as specified in the study protocol.

Exclusion criteria

  • Patients having secondary osteoporosis or another condition that presents low bone mass.
  • Patients having findings that affect measurement of lumbar spinal bone mineral density by DXA
  • Patients that have been administered bisphosphonate derivatives.
  • Other exclusion criteria as specified in the study protocol.

Treatment and study plan

ONO-5920

Drug

Primary outcomes

  1. Mean bone mineral density of the lumbar spine (L2-4 BMD)

Secondary outcomes

  1. Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2003
Primary completion
2006
First posted
Sep 21, 2005
Registry last updated
Oct 11, 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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