Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165607
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : January 29, 2010
Sponsor:
Information provided by:
Eisai Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: MENATETRANONE Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 1996
Actual Primary Completion Date : June 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. New incidence of vertebral fracture at 36 months. vertebral fracture is morphological transformation.

Secondary Outcome Measures :
  1. 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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165607


Locations
Layout table for location information
Japan
Omura, Nagasaki-prefecture, Japan, 856-0835
Sponsors and Collaborators
Eisai Limited
Investigators
Layout table for investigator information
Study Director: Norio Iinuma Post-Marketing Clinical Research Department. Clinical Research Center
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00165607    
Other Study ID Numbers: GA001R00
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases