Overview

This trial is active, not recruiting.

Condition postmenopausal women with osteoporosis
Treatments romosozumab, alendronate
Phase phase 3
Sponsor Amgen
Start date May 2012
End date February 2017
Trial size 4094 participants
Trial identifier NCT01631214, 2011-003142-41, 20110142

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)
Romosozumab sub-cutaneous injections and placebo alendronate (oral) for 12 months, followed by open-label alendronate (oral) for at least another 12 months (until end of study)
romosozumab sclerostin anitbody
Romosozumab sub-cutaneous injections and placebo alendronate (oral) for 12 months followed by open-label alendronate (oral) for at least another 12 months (until end of study)
(Active Comparator)
Oral alendronate plus placebo AMG 785 sub-cutaneous injections for 12 months, followed by open-label alendronate (oral) for at least another 12 months (until end of study)
alendronate biophosphantes, Fosamax
Oral alendronate and placebo AMG 785 sub-cutaneous injections for 12 months, followed by open-label alendronate, (oral) for at least another 12 months (until end of study)

Primary Outcomes

Measure
Incidence of clinical fracture
time frame: From baseline until the date of first clinical fracture assessed (approximately 24 months)
Incidence of new vertebral fracture
time frame: 24 months

Secondary Outcomes

Measure
Incidence of fracture
time frame: 12 months
Percent changes in DXA Bone Mineral Density from baseline to 12 months
time frame: 12 months
Incidence of fracture
time frame: From baseline until the date of first clinical fracture assessed (approximately 24 months)
Percent changes in DXA Bone Mineral Density from baseline to 24 months
time frame: 24 Months
Percent changes in DXA Bone Mineral Density from baseline to 36 months
time frame: 36 Months

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: 1. a hip BMD T-score of ≤-2.5 SD and a vertebral fracture or 2. a hip BMD T-score of ≤-2.0 SD and a recent hip fracture or two vertebral fractures. Exclusion Criteria: 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 Possible signs of intolerance to Alendronate

Additional Information

Official title A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Amgen.