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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00165698

Enrollment

240

Registered

2005-09-14

Start date

2005-05-31

Completion date

2007-07-31

Last updated

2014-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

Keywords

Postmenopausal, osteoporosis

Brief summary

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

Interventions

DRUGmenatetranone

15 mg three times a day orally for 12 months

DRUGalfacalcidol

0.25 μg twice a day orally for 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months	Baseline and 12 months
Height (Meter)	Baseline and 12 months
New Fracture and Fall	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

Countries

China

Participant flow

Participants by arm

Arm	Count
Menatetrenone 15 mg t.i.d. orally for 12 months	112
Alfacalcidol 0.25 μg b.i.d. orally for 12 months	108
Total	220

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	2	10
Overall Study	Lost to Follow-up	2	2
Overall Study	Not Taken/Lost the medicine	1	2
Overall Study	Protocol Violation	1	0
Overall Study	Withdrawal by Subject	2	1

Baseline characteristics

Characteristic	Alfacalcidol	Total	Menatetrenone
Age, Continuous	64.2 years STANDARD_DEVIATION 6.3	64.4 years STANDARD_DEVIATION 6.2	64.6 years STANDARD_DEVIATION 6.1
Race/Ethnicity, Customized Asian	108 participants	220 participants	112 participants
Region of Enrollment China	108 participants	220 participants	112 participants
Sex: Female, Male Female	108 Participants	220 Participants	112 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	81 / 117	74 / 118
serious Total, serious adverse events	8 / 117	6 / 118