Clinical trial: Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women (NCT00165698)

Eligibility criteria:
Inclusion criteria :

          -  Postmenopausal women with menopause duration more than 5 years and with age between
             45-75 years old (menopausal age ≥40), or if hysterectomy operated before natural
             menopause, the age of women between 60-75 years old.

          -  Subject with BMD (L2-4 or neck of femur) being more than 2 Standard Deviation (SD)
             below the young female adult mean (According to the standard of each center)

          -  BMI between 18 kg/m2-30 kg/m2.

          -  The anatomic structure of lumbar spine must be available for Dual-energy X-ray
             Absorptiometry (DEXA) examination, patient with serious scoliosis, bone trauma or
             sequela after orthopedics surgery, which makes BMD measurement difficult, should be
             excluded

          -  Subject who have given informed consent prior to participation in the trial and who
             undertake to comply with the protocol.

        Exclusion Criteria

          -  Subject with conditions that are considered to effect osteoporosis, such as clear
             definite diabetes mellitus, rheumatoid arthritis, rheumatoid arthritis,
             hyperparathyroidism or other bone metabolic diseases.

          -  Subjects who have received treatment with active-type vitamin D3 preparation, other
             vitamin D preparations (>1000IU per day）, calcitonin, corticosteroid hormone,
             androgen, estrogen, other hormone, vitamin K preparation, in the 3 months prior to
             inanition of this study; Subjects who have received treatment with bisphosphonate
             preparation or Sodium Fluoride in the 1 year prior to inanition of this study;
             Subjects who have received treatment with Selective Estrogen Receptor Modulator (SERM)
             in the 6 months prior to inanition of this study

          -  Concurrent serious renal disease, hepatic disease, uncontrolled hypertension
             （≥150/100mmHg）, symptomatic ischemic heart disease, cerebral infarction or
             arteriosclerosis obliterans.

          -  Cancer history within 5 years.

          -  Subjects who take antacid containing aluminum in the preparation, warfarin or
             thrombolytic agents.

          -  Subject with any known abnormality in laboratory tests, which is deemed to be
             clinically significant by the investigator, which include:

          -  Serum alkaline phosphatace (ALP) > upper normal limit 10% (calculated according to the
             range of normal values of each center);

          -  Glutamic Oxalacetic Transaminase (AST)/ Glutamic Pyruvic Transaminase (ALT) > upper
             normal limit 50％(calculated according to the range of normal values of each center);

          -  Serum creatinine >1.5mg/dL (133μmol/L);

          -  Blood-fasting sugar ≥ 7mmol/L (126mg/L)

          -  Inability of subject to return for scheduled visits or to comply with any other aspect
             of the protocol.

          -  Subject who, in the opinion of the investigator, are poor medical candidates or pose
             any other risk for therapy with an investigational drug.
Female

Subject must be at least 45 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Entailment