Overview

This trial is active, not recruiting.

Condition postmenopausal osteoporosis
Treatments amg 785, placebo, denosumab
Phase phase 3
Sponsor Amgen
Start date March 2012
End date December 2015
Trial size 7180 participants
Trial identifier NCT01575834, 20070337, 2011-001456-11

Summary

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
sub-cutaneous AMG 785 injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months
amg 785
Sub-cutaneous AMG 785 injections for first 12 months of the study
denosumab
Sub-cutaneous open-label denosumab injections for months 13-24 of the study.
(Placebo Comparator)
sub-cutaneous placebo injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months
placebo
Sub-cutaneous placebo injections for first 12 months of the study.
denosumab
Sub-cutaneous open-label denosumab injections for months 13-24 of the study.

Primary Outcomes

Measure
Incidence of vertebral fracture
time frame: 12 Months
Incidence of vertebral fracture
time frame: 24 Months

Secondary Outcomes

Measure
Incidence of Fracture
time frame: 12 Months
Changes In Bone Mineral Density from Baseline to 12 Months
time frame: 12 Months
Incidence of Fracture
time frame: 24 Months
Changes In Bone Mineral Density from Baseline to 24 Months
time frame: 24 Months

Eligibility Criteria

Female participants from 55 years up to 90 years old.

Inclusion Criteria: -Postmenopausal women osteoporosis, defined as low bone mineral density Exclusion Criteria: - Severe osteoporosis - Use of agents affecting bone metabolism - History of metabolic or bone disease (except osteoporosis) - Vitamin D insufficiency (vitamin D repletion and rescreening is permitted) - Current hyper- or hypocalcemia - Current, uncontrolled hyper- or hypothyroidism - Current, uncontrolled hyper- or hypoparathyroidism

Additional Information

Official title A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women With Osteoporosis
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Amgen.