Status:
COMPLETED
Randomized, Open, Parallel, Active Controlled Study on Fracture Prevention in Antiosteoporosis Treatment (OF Study)
Lead Sponsor:
Eisai Limited
Conditions:
Osteoporosis
Eligibility:
FEMALE
50+ years
Phase:
PHASE4
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 cal...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 1996
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00165607
Start Date
April 1 1996
Last Update
January 29 2010
Active Locations (1)
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1
Ōmura, Nagasaki, Japan, 856-0835