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

Phase 3CompletedNCT02063854

Takeda871 enrolled

Overview

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.

The primary objective of the present study is to verify the non-inferiority of once-monthly oral administration of NE-58095 DR tablets for 12 months to once-daily oral administration of NE-58095 IR 2.5 mg tablets for 12 months, in terms of efficacy in participants with involutional osteoporosis. Secondary objectives of the present study are as follows: to compare the safety of once-monthly oral administration of NE-58095 DR tablets for 12 months with the safety of once-daily oral administration of NE-58095 IR tablets (at 2.5 mg) for 12 months in participants with involutional osteoporosis at time of wakening.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

871

Conditions

Involutional Osteoporosis

Interventions

NE-58095 IRDRUG

NE-58095 IR tablets

NE-58095 IR PlaceboDRUG

NE-58095 IR placebo-matching tablets

NE-58095 DRDRUG

NE-58095 DR tablets

NE-58095 DR Placebo

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with a diagnosis of involutional osteoporosis 2. Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent 3. Women for whom at least 2 years have passed since the last natural menstruation Exclusion Criteria: 1. Patients with secondary osteoporosis 2. Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass 3. Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA) 4. Patients with a history of radiotherapy to the lumbar spine or the pelvis 5. Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period 6. 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 7. Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period 8. Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period 9. Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding 10. Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus) 11. Patients with hypocalcemia 12. Patients with hypercalcemia 13. Patients with a diagnosis of renal calculus 14. Patients with serious renal, hepatic, or cardiac disease 15. 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.

Locations (25)

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Chiba, Chiba, Japan

Unnamed facility

Outcomes

Primary Outcomes

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.

Time frame: Baseline and End of Study (up to Month 12)

Secondary Outcomes

Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit

The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.

Time frame: 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

The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.

Time frame: 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

The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.

Time frame: 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

The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.

Time frame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)

Data from ClinicalTrials.gov

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NE-58095 DR placebo-matching tablets

Narashino-shi, Chiba, Japan

Unnamed facility

Fukuoka, Fukuoka, Japan

Unnamed facility

Kitakyushu-shi, Fukuoka, Japan

Unnamed facility

Onga-gun, Fukuoka, Japan

Unnamed facility

Ebetsu-shi, Hokkaido, Japan

Unnamed facility

Sapporo, Hokkaido, Japan

Unnamed facility

Kako-gun, Hyōgo, Japan

Unnamed facility

Morioka, Iwate, Japan

...and 15 more locations

Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.