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Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy

NCT00919711 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 870

Last updated 2020-07-28

Study results available
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Summary

A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily Alendronate therapy.

Conditions

Interventions

DRUG

Actonel®

Oral Actonel® (Risedronate) in total a 150mg per month (one 75mg tablet to be taken on each of 2 consecutive days per month).

DRUG

Denosumab

Denosumab 60 mg, once every 6 months, Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-01
Primary Completion
2011-12-21
Completion
2012-03-05

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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 NCT00919711 on ClinicalTrials.gov