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

Information source: Ajinomoto Pharmaceuticals Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Involutional Osteoporosis

Intervention: NE-58095 (Drug); NE-58095NF (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Ajinomoto Pharmaceuticals Co., Ltd.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Mean bone mineral density of the lumbar spine (L2- L4) determined by dual energy X-ray absorptiometry (DXA)

Frequency of Adverse events

Vtal signs (As vital signs, body temperature (axilla), blood pressure while sitting (rest for 5 minutes or longer), and pulse (bpm) will be measured)

Laboratory parameters (bloodbiochemistry, hematology, and urinalysis)

Secondary outcome:

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

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

Percent changes from baseline in biochemical bone metabolic markers at each evaluation time point

Incidence of non-traumatic new vertebral body fractures

Detailed 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 osteoporosis at time of wakening

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 has passed since the last natural menstruation

Exclusion Criteria:

- 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-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

Locations and Contacts

Tsurukami Clinic of Orthopedics and Rheumatology, Tamana-City, Kumamoto 865-0015, Japan
Additional Information

Starting date: February 2014
Last updated: January 15, 2015

Page last updated: August 20, 2015

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