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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
MENATETRANONE
Sponsored by
Eisai Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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; Patients showing osteophytes connecting with adjacent vertebral osteophytes Patients showing hyperostosis of ligament around the vertebral body Patients showing inter-body fusion Patients who experienced surgical intervention(s) in the spine 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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
January 28, 2010
Sponsor
Eisai Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00165607
Brief Title
Randomized, Open, Parallel, Active Controlled Study on Fracture Prevention in Antiosteoporosis Treatment (OF Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Limited

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MENATETRANONE
Primary Outcome Measure Information:
Title
New incidence of vertebral fracture at 36 months. vertebral fracture is morphological transformation.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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; Patients showing osteophytes connecting with adjacent vertebral osteophytes Patients showing hyperostosis of ligament around the vertebral body Patients showing inter-body fusion Patients who experienced surgical intervention(s) in the spine 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norio Iinuma
Organizational Affiliation
Post-Marketing Clinical Research Department. Clinical Research Center
Official's Role
Study Director
Facility Information:
City
Omura
State/Province
Nagasaki-prefecture
ZIP/Postal Code
856-0835
Country
Japan

12. IPD Sharing Statement

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

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