Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis

Amgen

Status and phase: Completed; Phase 3

Conditions: Osteoporosis; Osteopenia

Treatments: Biological: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00523341

20060289

Details and patient eligibility

About

The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who previously received denosumab or placebo, respectively.

Enrollment: 4,550 patients

Sex: Female

Ages: 60 to 94 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Postmenopausal women who have attended the 20030216 (NCT00089791) study month 36 visit will be eligible to participate if they meet the inclusion and exclusion criteria given below.

Inclusion Criteria

• Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60 mg subcutaneous 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.

Exclusion Criteria

• Permanently non-ambulatory subjects (use of an assistive device eg, cane, walker, etc. is permitted)
• Missed 2 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4,550 participants in 1 patient group

Denosumab

Experimental group

Description:

Participants received a 60 mg subcutaneous injection of denosumab every 6 months for seven years.

Treatment:

Biological: Denosumab