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Completed

NCT Number: NCT01522521

Study of AK156 in Primary Osteoporosis Patients

The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.

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Key information

Conditions

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

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chiba, 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 diagnosed with primary osteoporosis
  • Patients who have vertebral fractures at the time of screening

Exclusion criteria

  • Patients diagnosed with secondary osteoporosis
  • Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study

Treatment and study plan

AK156

Drug

zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years

Placebo

Drug

placebo (i.v.)/year + daily calcium and vitamin D for 2 years

Primary outcomes

  1. New vertebral fractures

    Time frame: 2 Years

    Reduction in the incidence rate of new fragility vertebral fractures

Secondary outcomes

  1. Vertebral fractures (worsening and new)

    Time frame: 2 Years

    The incidence rate of fragility vertebral fractures (worsening and new)

  2. Clinical fractures

    Time frame: 2 Years

    The incidence rate of Clinical fractures

  3. Bone mineral density

    Time frame: 2 Years

    The percent change from baseline in bone mineral density of lumbar spine and hip

  4. Bone metabolic marker

    Time frame: 2 Years

    The percent change from baseline in bone metabolic marker

Sponsors and collaborators

Lead sponsor

Asahi Kasei Therapeutics Corporation

Industry

Registry information

Official study title

Phase 3 Study of AK156 in Primary Osteoporosis Patients

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 31, 2012
Registry last updated
Oct 2, 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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