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

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low Bone Mineral Density

Intervention: AMG 162 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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

Clinical Details

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

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

Primary outcome:

Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

Secondary outcome:

Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8

Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: May 2006
Last updated: December 4, 2013

Page last updated: August 23, 2015

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