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Study of Transitioning From Alendronate to Denosumab

NCT00377819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2011-07-11

Study results available
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Summary

The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

alendronate

70 mg oral QW

DRUG

Denosumab (AMG 162)

60 mg SC q 6 mos

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-03-31
Completion
2008-07-31

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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 NCT00377819 on ClinicalTrials.gov