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

NCT00165698 | Completed Phase 3 Results

• 1 other identifier: AS-012 (GLA-CHN-05-01)
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Postmenopausal Osteoporosis

Keywords

Postmenopausal; osteoporosis

Outcome Measures

Primary Outcomes (3)

• Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months

  Baseline and 12 months

• Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months

  Baseline and 12 months

• Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months

  Baseline and 12 months

Secondary Outcomes (7)

• Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months

  Baseline and 12 months

• Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months

  Baseline and 12 months

• Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months

  Baseline and 12 months

• Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months

  Baseline and 12 months

• Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months

  Baseline and 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: menatetranone

2

ACTIVE COMPARATOR

Drug: alfacalcidol

Interventions

menatetranone DRUG

15 mg three times a day orally for 12 months

1

alfacalcidol DRUG

0.25 μg twice a day orally for 12 months

2

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (5)

Beijing Hospital

Beijing, China

Location

Chinese PLA General Hospital

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Hua Dong Hospital

Shanghai, China

Location

The Sixth People's Hospital affiliated to Shanghai Jiaopong University

Shanghai, China

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

alfacalcidol

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Takao Ishii, Asia regulatory affaires
• Organization: Eisai Co., Ltd.

81-3-3817-3914

Study Officials

• Hong Di

  Eisai China Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: May 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: July 1, 2007
• Last Updated: July 22, 2014
• Results First Posted: August 11, 2011

Record last verified: 2014-07

Locations

CN (5)