Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eisai Limited
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.