Phase 3
N=871
A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
Involutional Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT02063854 ↗Enrolled (actual)
871
Serious AEs
5.5%
Results posted
Feb 2017
Primary outcome: Primary: 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 — 5.07; 3.36; 4.11 percent change — p=0.1346
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NE-58095 IR (Drug); NE-58095 IR Placebo (Drug); NE-58095 DR (Drug); NE-58095 DR Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
5.07; 3.36; 4.11 | 0.1346 |
| SECONDARY Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit |
3.18; 1.73; 1.92; 2.40; 3.67; 2.70 | — |
| SECONDARY Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit |
1.10; 0.91; 0.43; 0.54; 0.77; 0.78 | — |
| SECONDARY Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit |
1.34; 1.57; 0.70; 0.80; 1.46; 1.09 | — |
| SECONDARY Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit |
1.07; 0.90; 0.71; 0.49; 1.01; 0.57 | — |
| SECONDARY Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit |
-41.02; -17.42; -15.53; -18.80; -33.52; -24.74 | — |
| SECONDARY Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit |
-3.04; -2.93; -2.61; -3.61; -4.16; -3.69 | — |
| SECONDARY Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit |
-32.38; -17.26; -17.49; -21.05; -30.75; -25.20 | — |
| SECONDARY Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit |
-6.55; -9.08; -7.70; -9.73; -13.68; -9.86 | — |
| SECONDARY Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit |
-32.73; -11.79; -12.42; -17.15; -29.81; -16.42 | — |
| SECONDARY Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) |
2.1; 3.3; 2.1; 3.2; 3.4; 1.1 | — |
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.
Eligibility 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 have 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-receptor activator of nuclear factor-κB ligand (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.
Data sourced from ClinicalTrials.gov (NCT02063854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.