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Phase 2 Study of AMG 785 in Postmenopausal Women With Low Bone Mineral Density - NCT00896532-(Clinical Trial 290864)



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City:  Portland
State:  
OR
Zip Code:
Conditions: Low Bone Mineral Density - Postmenopausal Osteoporosis
Purpose: This phase 2 clinical trial will study the safety and efficacy of AMG 785, an investigational bone building agent, in the treatment of postmenopausal women with low bone mineral density. Different doses and dosing frequencies of AMG 785 will be compared to placebo in a double-blind fashion. In addition, AMG 785 will be compared to open label alendronate and open label teriparatide. The clinical hypothesis is that AMG 785 compared with placebo will cause a greater percent change from baseline in lumbar spine bone mineral density.
Study summary:
Criteria: Inclusion Criteria: - Ambulatory, postmenopausal women, aged ≥ 55 to ≤ 85 - Low BMD measured by Dual energy X-ray Absorptiometry (DXA) and assessed by the central imaging vendor (equivalent to T-scores between -2.0 and -3.5) Exclusion Criteria: - History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50 - Untreated hyper- or hypothyroidism - Current hyper- or hypoparathyroidism, hypo- or hypercalcemia - Elevated transaminases - Significantly impaired renal function - Positive for: HIV, Hep-C or Hep-B surface antigen - Malignancy - History of solid organ or bone marrow transplants - Use of agents affecting bone metabolism - Contraindicated or intolerant of alendronate therapy - Contraindicated or intolerant of teriparatide therapy
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2010
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