A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

Phase 3CompletedNCT02016716

Amgen294 enrolled

Overview

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups: * Romosozumab 90 mg/mL * Placebo 90 mg/mL * Romosozumab 70 mg/mL * Placebo 70 mg/mL After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9. For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

294

Conditions

Postmenopausal Osteoporosis

Interventions

Romosozumab 90 mg/mLDRUG

Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).

Placebo 90 mg/mLDRUG

Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.

Romosozumab 70 mg/mLDRUG

Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (12)

Research Site

Gainesville, Georgia, United States

Research Site

Bethesda, Maryland, United States

Research Site

Brno, Czechia

Research Site

Klatovy, Czechia

Outcomes

Primary Outcomes

Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine

Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Time frame: Baseline and month 6

Secondary Outcomes

Percent Change From Baseline in Total Hip BMD

Total hip BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline total hip BMD T-score.

Time frame: Baseline and month 6

Percent Change From Baseline in Femoral Neck BMD

Femoral neck BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline femoral neck BMD T-score.

Time frame: Baseline and month 6

Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)

Time frame: Baseline, month 1, month 3, and month 6

Percent Change From Baseline in Serum C-Telopeptide (CTX)

Time frame: Baseline, month 1, month 3, and month 6

Data from ClinicalTrials.gov

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