Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: menatetranone; alfacalcidol
Intervention description: 15 mg three times a day orally for 12 months; 0.25 μg twice a day orally for 12 months
Intervention MeSH terms: Alfacalcidol; Hydroxycholecalciferols
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: Female
Minimum age: 45 Years
Maximum age: 75 Years
Keywords: Postmenopausal; osteoporosis

Summary:

      To determine the effect and safety of menatetrenone on treatment of postmenopausal
      osteoporosis comparing with alfacalcidol.
    

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.