Efficacy and Safety of AAE581 in postmenopausal women with Osteopenia/Osteoporosis.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220152

Enrollment

160

Registered

2005-10-20

Start date

2005-10-20

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 : AAE581 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigation

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Inclusion criteria - Low spine Bone Mineral Density - 0 to 1 prevalent fracture in non lumber spine Exclusion criteria - History or presence of any bone disease other than osteopenia/osteoporosis - Previous treatment with other anti-osteoporosis agent( Wash out required) - Evidence of vitamin D deficiency Other protocol-defined exclusion criteria may apply.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Primary Outcomes: Change of lumber spine( L1-L4) BMD at 12 months; Safety of 12 month treatment Secondary Outcomes: Change of BMD of lumber spine(L1-L4, L2-L4), total hip, femoral neck, forearm and total body at 3,6,9 and 12 months; Change of Bone markers (Serum CTX, P1NP, OC, BASP and urinary NTX, Dpyr at 1,3,6,9 and 12 months; Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and12 months.	—

Outcome results

None listed

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