Clinical trial NCT02063854: A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
Official title: A Phase 2/3, Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Once-monthly Oral Administration of NE-58095DR Tablet (25 mg or 37.5 mg) Versus Once-daily Oral Administration of NE-58095IR Tablet (2.5 mg) for the Treatment of Involutional Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Involutional Osteoporosis
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: EA Pharma Co., Ltd.
First posted: 2014-02-14
Enrollment: 871
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline and End of Study (up to Month 12)
Secondary outcomes:
measure: Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
timeFrame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
measure: Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
timeFrame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
measure: Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
timeFrame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
measure: Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
timeFrame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
measure: Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
timeFrame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
measure: Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
timeFrame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
measure: Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
timeFrame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
measure: Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
timeFrame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
measure: Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
timeFrame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
measure: Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Chiba-shi
country: Japan
state: Chiba
city: Narashino-shi
country: Japan
state: Chiba
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Kitakyushu-shi
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Ebetsu-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Kako-gun
country: Japan
state: Hyogo
city: Morioka-shi
country: Japan
state: Iwate
city: Atsugi-shi
country: Japan
state: Kanagawa
city: Kawasaki-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Zushi-shi
country: Japan
state: Kanagawa
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Tamana-shi
country: Japan
state: Kumamoto
city: Sendai-shi
country: Japan
state: Miyagi
city: Tagajo-shi
country: Japan
state: Miyagi
city: Miyazaki-shi
country: Japan
state: Miyazaki
city: Saito-shi
country: Japan
state: Miyazaki
city: Higashi Osaka-shi
country: Japan
state: Osaka
city: Saitama-shi
country: Japan
state: Saitama
city: Daito-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Wakayama-shi
country: Japan
state: Wakayama
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: