A Phase 2/3, Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Once-monthly Oral Administration of NE-58095DR Tablet (25 mg or 37.5 mg) Versus Once-daily Oral Administration of NE-58095IR Tablet (2.5 mg) for the Treatment of Involutional Osteoporosis
Sponsor study identifier
Secondary identifiers
REGISTRY · JapicCTI
REGISTRY · WHO
OTHER · Takeda ID
interventional
871
1 country
25
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12 months in participants with involutional osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5 mg tablets once daily for 12 months are set as the control group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
February 12, 2014
Actual (reported)February 14, 2014
Actual (reported)November 2015
Actual (reported)November 2015
Actual (reported)February 23, 2017
Actual (reported)Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study
The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.
Baseline and End of Study (up to Month 12)
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
NE-58095 IR tablets
NE-58095 IR placebo-matching tablets
Nagoya, Aichi-ken, Japan
Chiba, Chiba, Japan
Narashino-shi, Chiba, Japan
Fukuoka, Fukuoka, Japan
Kitakyushu-shi, Fukuoka, Japan
Onga-gun, Fukuoka, Japan
Ebetsu-shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
The collaborator company name EA Pharma Co., Ltd. has been changed from 1st April 2016. The legacy name was Ajinomoto Pharmaceutics Co., Ltd.
Medical Director Clinical Science
Takeda
871 participants (actual enrollment reported by the registry).
First Submitted
February 12, 2014
First Posted
February 14, 2014
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
NE-58095 DR tablets
NE-58095 DR placebo-matching tablets
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Kako-gun, Hyōgo, Japan
Morioka, Iwate, Japan
Atsugi-shi, Kanagawa, Japan
Kawasaki-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Zushi-shi, Kanagawa, Japan
Kumamoto, Kumamoto, Japan
Tamana-shi, Kumamoto, Japan
Sendai, Miyagi, Japan
Tagajō-shi, Miyagi, Japan
Miyazaki, Miyazaki, Japan
Saito-shi, Miyazaki, Japan
Higashi Osaka-shi, Osaka, Japan
Saitama-shi, Saitama, Japan
Daito-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Wakayama, Wakayama, Japan
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
February 23, 2017
Results First Posted
February 23, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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