Status:
COMPLETED
Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
45-75 years
Phase:
PHASE3
Brief Summary
To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00165698
Start Date
May 1 2005
End Date
July 1 2007
Last Update
July 22 2014
Active Locations (5)
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1
Beijing Hospital
Beijing, China
2
Chinese PLA General Hospital
Beijing, China
3
Peking Union Medical College Hospital
Beijing, China
4
Hua Dong Hospital
Shanghai, China