Clinical trial NCT00165698: Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
Official title: Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal
osteoporosis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 240
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months
timeFrame: Baseline and 12 months
measure: Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months
timeFrame: Baseline and 12 months
measure: Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months
timeFrame: Baseline and 12 months
measure: Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months
timeFrame: Baseline and 12 months
measure: Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months
timeFrame: Baseline and 12 months
measure: Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months
timeFrame: Baseline and 12 months
measure: Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months
timeFrame: Baseline and 12 months
measure: New Fracture and Fall
timeFrame: 12 months
measure: Height (Meter)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Hua Dong Hospital
city: Shanghai
country: China
facility: The Sixth People's Hospital affiliated to Shanghai Jiaopong University
Study officials:
affiliation: Eisai China Inc.
name: Hong Di
role: STUDY_DIRECTOR
References: