An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density

• Status: Completed
• Trial end date: 2012-08-02
• Target enrollment: 0
• Participant gender: Female

Summary

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab

Criteria

Inclusion Criteria:

• Subject must be ambulatory

• Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit

• signed informed consent must be obtained before any study-specific procedures

Exclusion Criteria:

• Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.

• Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.

• Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.

• Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.