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 3

Completed

• Conditions: Low Bone Mineral Density
• Interventions: Drug: AMG 162

• Registration Number: NCT00325468
• Lead Sponsor: Amgen

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-01
• Study First Submitted: 2006-05-10
• Study First Submitted QC: 2006-05-10
• Study First Posted: 2006-05-12
• Primary Completion: 2011-03-28
• Study Completion: 2012-08-02
• Results First Submitted: 2013-01-03
• Results First Submitted QC: 2013-07-23
• Results First Posted: 2013-07-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMG 162	AMG 162	AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42

Primary Outcome Measures

Name	Time	Method
Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8	8 years
Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8	8 years
Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8	8 years

Secondary Outcome Measures

Name	Time	Method
Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8	8 years
Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8	8 years