CompletedPhase 2/3

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

Japan871 participantsStarted 2014-02

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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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

What they're measuring

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)

Trial details

NCT IDNCT02063854

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11

Results submitted2016-11-16

View on ClinicalTrials.gov More Involutional Osteoporosis trials