MedTrace Logo

Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women

NCT00918749 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2015-06-29

Study results available
· View outcomes & findings →

Summary

Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

150 mg

150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.

DRUG

75 mg

75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

DRUG

100 mg

100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Chantell Wilson, PhD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00918749 on ClinicalTrials.gov