Overview

This trial is active, not recruiting.

Condition involutional osteoporosis
Treatments ne-58095, ne-58095nf
Phase phase 2/phase 3
Sponsor Takeda
Collaborator Ajinomoto Pharmaceuticals Co., Ltd.
Start date February 2014
End date November 2015
Trial size 760 participants
Trial identifier NCT02063854, CCT-401, JapicCTI-142440, NE-58095DR/CCT-401, U1111-1153-0440

Summary

The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of oral administration of NE-58095NF(New formulation) tablets for 12 months in patients with involutional osteoporosis. For this study, patients receiving oral NE-58095 2.5-mg tablets once daily for 12 months are set as the control group.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
NE-58095 (2.5-mg tablets) orally once daily at time of wakening+ Placebo (mimicking NE-58095NF tablets )+ Calcium lactate (background medication) orally once daily after dinner
ne-58095
NE-58095 tablets
(Experimental)
NE-58095NF tablet orally + Placebo (mimicking NE-58095NF tablets) +Placebo (mimicking NE-58095 2.5-mg tablets) orally once dailyat time of wakening + Calcium lactate (background medication) orally once daily after dinner
ne-58095
NE-58095NF tablets
(Experimental)
NE-58095NF tablet orally + Placebo (mimicking NE-58095NF tablets ) + Placebo (mimicking NE-58095 2.5-mg tablets) orally once daily at time of wakening + Calcium lactate (background medication) orally once daily after dinner
ne-58095nf
NE-58095NF tablets
(Experimental)
NE-58095NF tablet orally + Placebo (mimicking NE-58095NF tablets) + Placebo (mimicking NE-58095 2.5-mg tablets) orally once daily at time of wakening + Calcium lactate (background medication) orally once daily after dinner
ne-58095nf
NE-58095NF tablets
(Experimental)
NE-58095NF orally + Placebo (mimicking NE-58095NF tablets) + Placebo (mimicking NE-58095 2.5-mg tablets) orally once daily at time of wakening + Calcium lactate (background medication) orally once daily after dinner
ne-58095nf
NE-58095NF tablets
(Experimental)
NE-58095NF tablet orally + Placebo (mimicking NE-58095NF tablets ) + Placebo (mimicking NE-58095 2.5-mg tablets) orally once daily at time of wakening + Calcium lactate (background medication) orally once daily after dinner
ne-58095nf
NE-58095NF tablets
(Experimental)
NE-58095NF tablet orally + Placebo (mimicking NE-58095NF tablets)+ Placebo (mimicking NE-58095 2.5-mg tablets) orally once daily at time of wakening + Calcium lactate (background medication) orally once daily after dinner
ne-58095nf
NE-58095NF tablets

Primary Outcomes

Measure
Mean bone mineral density of the lumbar spine (L2- L4) determined by dual energy X-ray absorptiometry (DXA)
time frame: For 12 months
Frequency of Adverse events
time frame: For 12 months
Vtal signs (As vital signs, body temperature (axilla), blood pressure while sitting (rest for 5 minutes or longer), and pulse (bpm) will be measured)
time frame: Before administration, 0.5, 3, 6, 9, and 12 months (at discontinuation) after the start of administration
Laboratory parameters (bloodbiochemistry, hematology, and urinalysis)
time frame: Before administration, 0.5, 3, 6, 9, and 12 months (at discontinuation) after the start of administration

Secondary Outcomes

Measure
Percent changes from baseline in mean bone mineral density of the L2-L4 lumbar spine (determined by DXA) at the end of the treatment period
time frame: Before administration, 6, and 12 months (at discontinuation) after the start of administration
Percent changes from baseline in mean bone mineral density of the femur (whole bone, trochanteric region, and neck region) (determined by DXA) at the end of the treatment period
time frame: Before administration, 6, and 12 months (at discontinuation) after the start of administration
Percent changes from baseline in biochemical bone metabolic markers at each evaluation time point
time frame: Before administration, 1, 3, 6, 9, and 12 months (at discontinuation) after the start of administration
Incidence of non-traumatic new vertebral body fractures
time frame: For 12 months

Eligibility Criteria

Male or female participants at least 50 years old.

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 has 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-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 NFugs 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.

Additional Information

Official title A Phase II/III Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Oral Administration of NE-58095NF Tablets Versus Once-daily Oral Administration of NE-58095 2.5-mg Tablets for the Treatment of Involutional Osteoporosis
Description The primary objective of the present study is to verify the non-inferiority of oral administration of NE-58095NF tablets for 12 months to once-daily oral administration of NE-58095 2.5-mg tablets for 12 months, in terms of efficacy in patients with involutional osteoporosis. Secondary objectives of the present study are as follows: to compare the safety of oral administration of NE-58095NF tablets for 12 months with the safety of once-daily oral administration of NE-58095 tablets (at 2.5 mg) for 12 months in patients with involutional osteoporosisat time of wakening.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Takeda.