An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Density

Conditions: Treatment of postmenopausal osteoporosis
MedDRA version: 17.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2007-001041-17-FI

Lead Sponsor: Amgen Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 5600

Inclusion Criteria

Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60mg SC injection every 6 months.

Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit.

Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month 24.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 107
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4443

Exclusion Criteria

- Permanently non-ambulatory subjects (use of an assistive device e.g. cane, walker etc is permitted)
- Missed two or more investigational product doses during the 20030216 study
- 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
- Developed sensitivity to mammalian cell derived drug products during the 20030216 study
- 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)
- Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study
- 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