Randomized, Open, Parallel, Active Controlled Study on Fracture Prevention in Antiosteoporosis Treatment (OF Study)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Outcome Measures
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 []
Eligibility Criteria
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.
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Patients with primary osteoporosis (diagnosed according to "Diagnostic Criteria for Primary Osteoporosis issued by the Japanese Society for Bone and Mineral Research (1995)."
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Post-menopausal patients aged 50 years or older.
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Patients who agree to participate in a 4-year follow-up observation.
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Patients who provide written informed consent.
Exclusion Criteira:
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Patients on warfarin potassium (Warfarin®) therapy.
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Patients with hypercalcemia.
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Patietns with renal calculus.
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Patients with a known history of hypersensitivity to calcium or menatetrenone preparations.
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Patients with severe complication in the hepatic, renal, gastrointestinal, cardio- and cerebrovascular system.
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Patients who underwent bilateral ovariectomy.
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Patients with radiotherapy in the pelvis or para-aortic area.
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Patients with the following X-ray findings;
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Patients showing osteophytes connecting with adjacent vertebral osteophytes
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Patients showing hyperostosis of ligament around the vertebral body
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Patients showing inter-body fusion
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Patients who experienced surgical intervention(s) in the spine
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Patients with scoliosis which disturbs a diagnosing of vertebral fracture
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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).
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Patients who experienced bisphosphonates in the past.
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Patients who are likely to show insufficient absorption of liposoluble agents such as biliary atresia, impaired bile secretion, etc.
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Other patients who are judged to be ineligible for study entry by the investigator or investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Omura | Nagasaki-prefecture | Japan | 856-0835 |
Sponsors and Collaborators
- Eisai Limited
Investigators
- Study Director: Norio Iinuma, Post-Marketing Clinical Research Department. Clinical Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GA001R00