ITM-058 Phase 3 study

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 3 Study of ITM-058 in Patients with Osteoporosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223520

Enrollment

195

Registered

2017-05-08

Start date

2017-04-17

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

Osteoporosis

Interventions

investigational material(s) Generic name etc : Abaloparatide Acetate INN of investigational material : Abaloparatide Therapeutic category code : 243 Thyroid and para-thyroid hormone preparations Dosag

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with osteoporosis at high risk of fracture

Exclusion criteria

Exclusion criteria: Patients who may be affected by the secondary osteoporosis Patients who were treated with the drugs that may affect Calcium levels or bone metabolism Patients with a history of osteosarcoma

Design outcomes

Primary

Measure	Time frame
efficacy Percent change in lumber spine BMD at the last visit	—

Secondary

Measure	Time frame
safety efficacy Percent change in Hip BMD Incidence of new vertebral fractures Percent changes in bone metabolism markers Evaluation of the quality of life (QOL)(SF-36v2TM, RDQ) Safety	—

Countries

Japan

Outcome results

None listed

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