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

Involutional Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02063854
• Other study ID #: CCT-401
• Secondary ID: JapicCTI-142440U
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: February 12, 2014
• Last updated: August 11, 2015
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: August 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 760
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Involutional Osteoporosis
• Osteoporosis

Intervention

Drug:
• NE-58095
NE-58095 tablets
• NE-58095
NE-58095NF tablets
• NE-58095NF
NE-58095NF tablets
• NE-58095NF
NE-58095NF tablets
• NE-58095NF
NE-58095NF tablets
• NE-58095NF
NE-58095NF tablets
• NE-58095NF
NE-58095NF tablets

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Takeda	Ajinomoto Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean bone mineral density of the lumbar spine (L2- L4) determined by dual energy X-ray absorptiometry (DXA)	percent change from baseline in the mean bone mineral density of the L2-L4 lumbar spine [determined by the DXA] at the end of the treatment period	For 12 months	No
Primary	Frequency of Adverse events	Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.	For 12 months	Yes
Primary	Vtal signs (As vital signs, body temperature (axilla), blood pressure while sitting (rest for 5 minutes or longer), and pulse (bpm) will be measured)	For measured values and changes from baseline of these values, summary statistics are calculated at each evaluation time point. In addition, figures illustrating individual changes in vital signs are created for each treatment group.	Before administration, 0.5, 3, 6, 9, and 12 months (at discontinuation) after the start of administration	Yes
Primary	Laboratory parameters (bloodbiochemistry, hematology, and urinalysis)	For measured values and changes from baseline of these values, summary statistics are calculated at each evaluation time point. In addition, figures illustrating individual changes in laboratory parameters are created for each treatment group.; Number of participants who meet the Takeda markedly abnormal criteria for laboratory parameters at least once post dose.	Before administration, 0.5, 3, 6, 9, and 12 months (at discontinuation) after the start of administration	Yes
Secondary	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 L2-L4 lumbar spine (determined by DXA) at the end of the treatment period	Before administration, 6, and 12 months (at discontinuation) after the start of administration	No
Secondary	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 mean bone mineral density of the femur (whole bone, trochanteric region, and neck region) (determined by DXA) at the end of the treatment period	Before administration, 6, and 12 months (at discontinuation) after the start of administration	No
Secondary	Percent changes from baseline in biochemical bone metabolic markers at each evaluation time point	Percent changes from baseline in biochemical bone metabolic markers at each evaluation time point	Before administration, 1, 3, 6, 9, and 12 months (at discontinuation) after the start of administration	No
Secondary	Incidence of non-traumatic new vertebral body fractures	The incidence of new vertebral body fractures (including worsening of existing fractures) based on central results at each evaluation time point	For 12 months	No