Skip to main content
OpenTrials
Completed

NCT Number: NCT00680953

Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis

Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Involutional (postmenopausal and senile) osteoporosis with prevalent fragility vertebral fractures

Exclusion criteria

  • Any underlying condition,(other than BMD) that might have resulted in abnormal bone metabolism

Treatment and study plan

Denosumab

Drug

Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).

Placebo

Drug

Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).

Alendronate sodium hydrate

Drug

Oral tablet once a week for 24 months

Primary outcomes

  1. Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo

    Time frame: Baseline to 24 months

Secondary outcomes

  1. The Percentage of Non-vertebral Fractures

    Time frame: Baseline to 24 Months

    The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures

  2. Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.

    Time frame: Baseline to 24 Months

    The results are expressed as a percentage by Kaplan-Meier estimate.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of Denosumab in Japanese Osteoporotic Subjects With Prevalent Fragility Vertebral Fracture(s)

Acronym: DIRECT

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 20, 2008
Registry last updated
Mar 12, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.