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

Amgen

Status and phase

Completed

Phase 3

Conditions

Low Bone Mineral Density

Treatments

Drug: AMG 162

Study type

Interventional

Funder types

Industry

Identifiers

NCT00325468

20050233

Details and patient eligibility

About

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

Enrollment

200 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.