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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00165698
First received: September 12, 2005
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: menatetranone
Drug: alfacalcidol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • New Fracture and Fall [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Height (Meter) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: May 2005
Study Completion Date: July 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: menatetranone
15 mg three times a day orally for 12 months
Active Comparator: 2 Drug: alfacalcidol
0.25 μg twice a day orally for 12 months

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165698

Locations
China
Peking Union Medical College Hospital
Beijing, China
Chinese PLA General Hospital
Beijing, China
Beijing Hospital
Beijing, China
Hua Dong Hospital
Shanghai, China
The Sixth People's Hospital affiliated to Shanghai Jiaopong University
Shanghai, China
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Hong Di Eisai China Inc.
  More Information

No publications provided

Responsible Party: Takao Ishii, Asia regulatory affaires, Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00165698     History of Changes
Other Study ID Numbers: AS-012 (GLA-CHN-05-01)
Study First Received: September 12, 2005
Results First Received: December 2, 2010
Last Updated: July 11, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Eisai Inc.:
Postmenopausal
osteoporosis

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hydroxycholecalciferols
1-hydroxycholecalciferol
Menatetrenone
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014