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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

NCT00293813 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2014-07-25

Study results available
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Summary

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

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Alendronate

Alendronate 70 mg PO QW

DRUG

Denosumab

denosumab 60 mg SC q 6 mos

DRUG

Placebo

Placebo for alendronate and placebo for denosumab

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-03-31
Completion
2008-08-31

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00293813 on ClinicalTrials.gov