A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets

NCT02063854 | Completed Phase 2 Results DMC

• 4 other identifiers: CCT-401JapicCTI-142440U1111-1153-0440NE-58095DR/CCT-401
• Study Type: interventional
• Target: 871
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

Involutional Osteoporosis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (10)

• 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)

Study Arms (7)

NE-58095 IR 2.5 mg Once Daily on Awakening

ACTIVE COMPARATOR

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.

Drug: NE-58095 IR; Drug: NE-58095 DR Placebo

NE-58095 DR 25 mg Once Monthly on Awakening

EXPERIMENTAL

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.

Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo

NE-58095 DR 25 mg Once Monthly Following Breakfast

EXPERIMENTAL

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.

Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo

NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast

EXPERIMENTAL

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.

Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo

NE-58095 DR 37.5 mg Once Monthly on Awakening

EXPERIMENTAL

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.

Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo

NE-58095 DR 37.5 mg Once Monthly Following Breakfast

EXPERIMENTAL

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.

Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo

NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast

EXPERIMENTAL

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.

Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo

Interventions

NE-58095 IR DRUG

NE-58095 IR tablets

NE-58095 IR 2.5 mg Once Daily on Awakening

NE-58095 IR Placebo DRUG

NE-58095 IR placebo-matching tablets

NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast; NE-58095 DR 25 mg Once Monthly Following Breakfast; NE-58095 DR 25 mg Once Monthly on Awakening; NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast; NE-58095 DR 37.5 mg Once Monthly Following Breakfast; NE-58095 DR 37.5 mg Once Monthly on Awakening

NE-58095 DR DRUG

NE-58095 DR tablets

NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast; NE-58095 DR 25 mg Once Monthly Following Breakfast; NE-58095 DR 25 mg Once Monthly on Awakening; NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast; NE-58095 DR 37.5 mg Once Monthly Following Breakfast; NE-58095 DR 37.5 mg Once Monthly on Awakening

NE-58095 DR Placebo DRUG

NE-58095 DR placebo-matching tablets

NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast; NE-58095 DR 25 mg Once Monthly Following Breakfast; NE-58095 DR 25 mg Once Monthly on Awakening; NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast; NE-58095 DR 37.5 mg Once Monthly Following Breakfast; NE-58095 DR 37.5 mg Once Monthly on Awakening; NE-58095 IR 2.5 mg Once Daily on Awakening

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of involutional osteoporosis
• Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent
• Women for whom at least 2 years have passed since the last natural menstruation

You may not qualify if:

• Patients with secondary osteoporosis
• Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass
• Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA)
• Patients with a history of radiotherapy to the lumbar spine or the pelvis
• Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period
• Patients with a history of treatment with any anti-receptor activator of nuclear factor-κB ligand (RANKL) monoclonal antibodies or parathyroid hormone products within 1 year before the start of the treatment period
• Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period
• Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period
• Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding
• Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus)
• Patients with hypocalcemia
• Patients with hypercalcemia
• Patients with a diagnosis of renal calculus
• Patients with serious renal, hepatic, or cardiac disease
• Patients who have received surgical dental procedures, such as a tooth extraction (including dental implant treatment), but whose dental problems remain unresolved at the start of the treatment period.

Sponsors & Collaborators

• Takeda: lead
• EA Pharma Co., Ltd.: collaborator

Study Sites (25)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Chiba, Chiba, Japan

Location

Unknown Facility

Narashino-shi, Chiba, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Kitakyushu-shi, Fukuoka, Japan

Location

Unknown Facility

Onga-gun, Fukuoka, Japan

Location

Unknown Facility

Ebetsu-shi, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Kako-gun, Hyōgo, Japan

Location

Unknown Facility

Morioka, Iwate, Japan

Location

Unknown Facility

Atsugi-shi, Kanagawa, Japan

Location

Unknown Facility

Kawasaki-shi, Kanagawa, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Zushi-shi, Kanagawa, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Tamana-shi, Kumamoto, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Tagajō-shi, Miyagi, Japan

Location

Unknown Facility

Miyazaki, Miyazaki, Japan

Location

Unknown Facility

Saito-shi, Miyazaki, Japan

Location

Unknown Facility

Higashi Osaka-shi, Osaka, Japan

Location

Unknown Facility

Saitama-shi, Saitama, Japan

Location

Unknown Facility

Daito-ku, Tokyo, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, Japan

Location

Unknown Facility

Wakayama, Wakayama, Japan

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The collaborator company name EA Pharma Co., Ltd. has been changed from 1st April 2016. The legacy name was Ajinomoto Pharmaceutics Co., Ltd.

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 14, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-02

Locations

JP (25)