An open label, single arm, extension study to evaluate the long term safety and sustained efficacy of Denosumab (AMG 162) in the treatment of postmenopausal osteoporosis. - AMG 162 - Denosumab - 20060289

• Conditions: Treatment of Postmenopausal Osteoporosis.; MedDRA version: 9.1Level: LLTClassification code 10031282Term: Osteoporosis

• Registration Number: EUCTR2007-001041-17-IT
• Lead Sponsor: AMGEN S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-09
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 5600

Inclusion Criteria

All ambulatory postmenopausal women who have completed the 20030216 month 36 visit, remain on investigational product and meet the inclusion/exclusion criteria for this extension study as stated in Sections 4.1 and 4.2 will be eligible to participate.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

4.2.1 Permanently non-ambulatory subjects (use of an assistive device e.g. cane, walker etc is permitted) 4.2.2 Missed two or more investigational product doses during the 20030216 study 4.2.3 Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures 4.2.4 Developed sensitivity to mammalian cell derived drug products during the 20030216 study 4.2.5 Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits) 4.2.6 Receiving any investigational product other than denosumab 4.2.7 Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified