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

Low Bone Mineral Density Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325468
• Other study ID #: 20050233
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2006
• Last updated: December 4, 2013
• Start date: May 2006
• Est. completion date: August 2012

Study information

• Verified date: December 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Bone Mineral Density

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8		8 years	No
Primary	Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8		8 years	No
Primary	Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8		8 years	No
Secondary	Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8		8 years	No
Secondary	Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8		8 years	No

External Links

•   AmgenTrials clinical trials website