Overview

This trial is active, not recruiting.

Condition postmenopausal osteoporosis
Treatments romosozumab, placebo
Phase phase 3
Sponsor Amgen
Start date December 2013
End date September 2014
Trial size 294 participants
Trial identifier NCT02016716, 20120156

Summary

Purpose of this study is to evaluate the 2 formulations of Romosozumab in Postmenopausal Women With Osteoporosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
romosozumab formulation A
romosozumab AMG785
Active formulation (A) compared with Active formulation (B )
(Placebo Comparator)
placebo formulation A
placebo AMG785
placebo formulation A compared with placebo formulation B
(Active Comparator)
romosozumab formulation B
romosozumab AMG785
Active formulation (A) compared with Active formulation (B )
(Placebo Comparator)
placebo formulation B
placebo AMG785
placebo formulation A compared with placebo formulation B

Primary Outcomes

Measure
The primary endpoint is the percent change from baseline in DXA BMD at the lumbar spine (noninferiority)
time frame: 6 months

Secondary Outcomes

Measure
percent change from baseline in DXA BMD at the total hip
time frame: Month 6

Eligibility Criteria

Female participants from 55 years up to 90 years old.

Inclusion Criteria: Postmenopausal women with osteoporosis at high risk for fracture defined as - BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND - a history of fragility fracture or at least 2 other risk factors Exclusion Criteria: - BMD T score < -3.50 at the total hip or femoral neck. - History of hip fracture. - History of metabolic or bone disease (except osteoporosis). - Use of agents affecting bone metabolism. - Vitamin D insufficiency. - History of solid organ or bone marrow transplants. - Hyper- or hypocalcemia. - Hyper- or hypothyroidism. - Hyper- or hypoparathyroidism.

Additional Information

Official title A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate 2 Different Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Amgen.