CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 240 enrolled
Drug / intervention
menatetranone +1 moredrug
Likely dose
Menatetrenone 15 mg three times a day orally for 12 monthsAI-extracted
Key inclusion· 4
  • ✓Postmenopausal women with menopause duration >5 years, aged 45-75 years (or 60-75 if hysterectomized before natural menopause, with hysterectomy at any age)
  • ✓BMD (lumbar spine L2-L4 or femoral neck) >2 SD below young female adult mean
  • ✓BMI 18-30 kg/m²
  • ✓Lumbar spine anatomy suitable for DEXA measurement (no severe scoliosis, bone trauma, or orthopedic surgery sequelae compromising measurement)
Key exclusion· 5
  • ✕Conditions affecting bone metabolism: diabetes mellitus, rheumatoid arthritis, hyperparathyroidism, or other bone metabolic diseases
  • ✕Vitamin D3, vitamin D (>1000 IU/day), calcitonin, corticosteroids, androgens, estrogen, other hormones, or vitamin K within 3 months; bisphosphonates or sodium fluoride within 1 year; SERM within 6 months
  • ✕Serious renal or hepatic disease, uncontrolled hypertension (≥150/100 mmHg), symptomatic ischemic heart disease, cerebral infarction, or arteriosclerosis obliterans
  • ✕Cancer history within 5 years

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00165698
NCT00165698Phase 3Completed
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Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women

Eisai Co., Ltd.·interventional·Posted Sep 14, 2005·Updated Jul 22, 2014

In Brief

A Phase 3 clinical trial evaluating menatetranone and alfacalcidol for Postmenopausal Osteoporosis. Completed, enrolled 240 participants across 5 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartMay 1, 2005
Primary CompletionJan 1, 2007
Study CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 20.8 years ago

Interventions

menatetranonedrug

15 mg three times a day orally for 12 months

alfacalcidoldrug

0.25 μg twice a day orally for 12 months