Randomized, Open, Parallel, Active Controlled Study on Fracture Prevention in Antiosteoporosis Treatment (OF Study)

January 28, 2010 updated by: Eisai Limited
To investigate a new incidence and preventive effect of menatetrenone on vertebral fracture in patients with osteoporosis who were randomly assigned to either treatment arm receiving daily dose of calcium supplement as a monotherapy (calcium monotherapy group) or menatetrenone plus calcium supplement as a combination therapy (menatetrenone combo therapy group) for 36 months, followed by a 12-month follow-up observation to examine the preventive effect on the fracture risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Nagasaki-prefecture
      • Omura, Nagasaki-prefecture, Japan, 856-0835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Inpatient or outpatient is not asked. If using any anti-osteoporotic agent other than calcium preparations (i.e., contraindicated for concomitant use stipulated in the protocol of this post-marketing study), such agent must be discontinued. Even after the discontinuation, calcium dosing is permitted with a condition that the subsequent use is started after a 8-week elapse from the discontinuation.

  • Patients with primary osteoporosis (diagnosed according to "Diagnostic Criteria for Primary Osteoporosis issued by the Japanese Society for Bone and Mineral Research (1995)."
  • Post-menopausal patients aged 50 years or older.
  • Patients who agree to participate in a 4-year follow-up observation.
  • Patients who provide written informed consent.

Exclusion Criteira:

  • Patients on warfarin potassium (Warfarin®) therapy.
  • Patients with hypercalcemia.
  • Patietns with renal calculus.
  • Patients with a known history of hypersensitivity to calcium or menatetrenone preparations.
  • Patients with severe complication in the hepatic, renal, gastrointestinal, cardio- and cerebrovascular system.
  • Patients who underwent bilateral ovariectomy.
  • Patients with radiotherapy in the pelvis or para-aortic area.

  • Patients with the following X-ray findings;

    1. Patients showing osteophytes connecting with adjacent vertebral osteophytes
    2. Patients showing hyperostosis of ligament around the vertebral body
    3. Patients showing inter-body fusion
    4. Patients who experienced surgical intervention(s) in the spine
    5. Patients with scoliosis which disturbs a diagnosing of vertebral fracture
  • Patients who have been treated with anti-osteoporotic agents, other than calcium preparation, within 8 months prior to the study treatment (but not applied to the following; if discontinued, non-treated, or shifted to calcium monotherapy for 8 weeks or longer before starting the study treatment).
  • Patients who experienced bisphosphonates in the past.
  • Patients who are likely to show insufficient absorption of liposoluble agents such as biliary atresia, impaired bile secretion, etc.
  • Other patients who are judged to be ineligible for study entry by the investigator or investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
New incidence of vertebral fracture at 36 months. vertebral fracture is morphological transformation.

Secondary Outcome Measures

Outcome Measure
New incidence of clinical fracture (upper forelimb, femur, radius, and vertebral fracture associated with severe trauma that can cause fracture in normal bones of young adults) at 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Limited

Investigators

  • Study Director: Norio Iinuma, Post-Marketing Clinical Research Department. Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1996

Primary Completion (ACTUAL)

June 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 14, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2010

Last Update Submitted That Met QC Criteria

January 28, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA001R00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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