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Completed

NCT Number: NCT00794443

ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Bone Loss, Age-related Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hokkaido, 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 whose bone mineral density is <70% of Young Adult Mean (YAM), or <80% of YAM who have fragile fracture history
  • Patients can walk on his/her own
  • Written informed consent has been obtained from the patient.

Exclusion criteria

  • Sequential osteoporosis patients or patients with other disorders showing low bone mass
  • Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method
  • Patients who are unable to keep raising or standing for ≥30 min
  • Patients with peptic ulcer
  • Patients who have experienced anamnesis or gastrectomy (total extraction)

Treatment and study plan

YM529 / ONO-5920

Drug

Oral

Other names: YM529, ONO-5920, Minodronic acid

Primary outcomes

  1. Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method

    Time frame: At the final evaluation point

Secondary outcomes

  1. Time-course changes in the percent change of bone metabolism markers

    Time frame: Through the treatment period

  2. Time-course changes in the total femoral bone mineral density by the DXA method

    Time frame: Through the treatment period

  3. Assessment of adverse events, lab test values

    Time frame: Through the treatment period

  4. Frequency of fracture

    Time frame: At the final evaluation point

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

A Multi-center Double-blind Parallel-group Comparison Study in Involutional Osteoporosis Patients to Examine the Efficacy and Safety of ONO-5920/YM529 Monthly Intermittent Formulation With Its Daily Formulation.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 20, 2008
Registry last updated
May 4, 2015

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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