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

Phase 2

• Conditions: Osteoporosis

• Registration Number: JPRN-jRCT2080220152
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 160

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

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.