ITM-058 Phase 2 study

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2 Study of ITM-058 in Patients with Postmenopausal Osteoporosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222331

Enrollment

150

Registered

2013-12-17

Start date

2013-11-27

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

Female

Inclusion criteria

Inclusion criteria: Patients with postmenopausal 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(L2-L4) BMD at the last visit	—

Secondary

Measure	Time frame
safety efficacy Percent change in lumber spine Percent change in Hip BMD Percent changes in bone metabolism markers Safety	—

Countries

Japan

Outcome results

None listed

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