Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00170911
• Date of registration: 09/09/2005
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.
• Scientific title: Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.
• Date of first enrolment: March 2005
• Target sample size: 160
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00170911
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Contacts

• Name: Novartis
• Affiliation: Sponsor GmbH

Key inclusion & exclusion 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 inclusion/exclusion criteria may apply.



Age minimum: 50 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Osteoporosis

Intervention(s)

Drug: AAE581

Primary Outcome(s)

Safety of 12 month treatment

Change of lumbar spine(L1-L4)BMD at 12 months

Secondary Outcome(s)

Change of Bone markers(Serum CTX,P1NP, OC, BSAP and urinary NTX, DPyr at 1,3,6,9 and 12 months

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

Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and 12 months

Secondary ID(s)

CAAE581A1201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors