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

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.