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

Postmenopausal Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165698
• Other study ID #: AS-012 (GLA-CHN-05-01)
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: July 11, 2014
• Start date: May 2005
• Est. completion date: July 2007

Study information

• Verified date: July 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2007
• Est. primary completion date: January 2007
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• menatetranone
15 mg three times a day orally for 12 months
• alfacalcidol
0.25 µg twice a day orally for 12 months

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months		Baseline and 12 months	No
Primary	Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months		Baseline and 12 months	No
Primary	Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months		Baseline and 12 months	No
Secondary	Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months		Baseline and 12 months	No
Secondary	Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months		Baseline and 12 months	No
Secondary	Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months		Baseline and 12 months	No
Secondary	Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months		Baseline and 12 months	No
Secondary	Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months		Baseline and 12 months	No
Secondary	New Fracture and Fall		12 months	No
Secondary	Height (Meter)		Baseline and 12 months	No