A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

Amgen247 enrolled

Overview

This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

247

Conditions

Postmenopausal Osteoporosis

Interventions

AlendronateDRUG

Alendronate 70 mg PO QW

DenosumabDRUG

denosumab 60 mg SC q 6 mos

PlaceboDRUG

Placebo for alendronate and placebo for denosumab

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health. * Must have low bone mineral density and meet specific eligibility criteria. Key Exclusion Criteria: -Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.

Outcomes

Primary Outcomes

Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12

Cortical Thickness measured by XtremeCT.

Time frame: 12 months

Secondary Outcomes

Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12

Cortical Thickness measured by XtremeCT.

Time frame: 12 months

Data from ClinicalTrials.gov

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