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A phase III, double-blind, comparative study of NE-58095 (once-monthly formulation)

A phase III, double-blind, comparative study of NE-58095 (once-monthly formulation)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220992
Enrollment
Unknown
Registered
2010-02-01
Start date
2010-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Involutional osteoporosis

Interventions

investigational material(s) Generic name etc : NE-58095 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigati

Sponsors

Takeda Pharmaceutical Company Limited
Lead Sponsor
Ajinomoto Pharmaceuticals Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [Main inclusion criteria] -Aged 50 years or older at the time of obtaining consent -Female subjects must be at least 2 years postmenopausal (i.e., at least 2 years since last menstrual period)

Exclusion criteria

Exclusion criteria: [Main exclusion criteria] -Secondary osteoporosis -Presence of any disease that can decrease bone mass, except secondary osteoporosis -Findings that can affect DXA measurements of mean lumbar spine bone mineral density -Prior radiotherapy to the lumbar spine or pelvic region -Planned dental extraction or other dental surgical procedures (including dental implants) to be performed during the study period

Design outcomes

Primary

MeasureTime frame
Mean lumbar spine bone mineral density (BMD)—

Contacts

Public Contact; ;

Ajinomoto Pharmaceuticals Co., Ltd.;Takeda Pharmaceutical Company Limited

;;

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026