Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.
Phase 2
Completed
- Conditions
- Osteoporosis
- Registration Number
- NCT00170911
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
AAE581 is a specific inhibitor of the cysteine protease cathepsin K. This trial is designed to provide detailed information about the effects( efficacy and safety) of AAE581 on Bone Mineral Density.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
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 inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change of lumbar spine(L1-L4)BMD at 12 months Safety of 12 month treatment
- Secondary Outcome Measures
Name Time Method Change of BMD of lumbar 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, BSAP and urinary NTX, DPyr at 1,3,6,9 and 12 months Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and 12 months