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Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women | Clinical Trials | Clareo Health

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Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women

NCT00165698•Eisai Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

45 - 75 years

Sex

FEMALE

Healthy Volunteers

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)
+2 more criteria

Locations (5)

Beijing Hospital

Beijing, China

Chinese PLA General Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Hua Dong Hospital

Shanghai, China

The Sixth People's Hospital affiliated to Shanghai Jiaopong University

Shanghai, China

Key Dates

Start Date

May 1, 2005

Primary Completion Date

January 1, 2007

Completion Date

July 1, 2007

Last Updated

July 22, 2014

Enrollment

240

ACTUAL participants

Conditions

Postmenopausal Osteoporosis

Interventions

menatetranone

DRUG

alfacalcidol

DRUG

Anabolic Therapy in Postmenopausal Osteoporosis

NCT05010590

Postmenopausal Osteoporosis

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NOT_YET_RECRUITING

AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

NCT07329543

OsteoporosisPostmenopausal Osteoporosis

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WITHDRAWNNA

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women

Inclusion Criteria

Exclusion Criteria

Anabolic Therapy in Postmenopausal Osteoporosis

AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

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