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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00325468
First received: May 10, 2006
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Low Bone Mineral Density
Drug: AMG 162
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 2006
Study Completion Date: August 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325468

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00325468     History of Changes
Other Study ID Numbers: 20050233
Study First Received: May 10, 2006
Results First Received: January 3, 2013
Last Updated: December 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
bone loss
osteoporosis

ClinicalTrials.gov processed this record on April 17, 2014