A multicentre, double-blind, randomised, active controlled, parallel group, noninferiority study comparing 75mg risedronate dosed on two consecutive days monthly with 5mg daily risedronate in the treatment of postmenopausal osteoporosis as assessed over 24 months

Registry ID

EUCTR2004-000486-35

Source registry

EUCTR

Status

Completed

Phase

PHASE3

Sponsor

Procter & Gamble Pharmaceuticals

Start date

2005-09-27

Completion date

2007-02-28

Last update

2026-08-16

Conditions

• Postmenopausal osteoporosis

Summary

To determine the efficacy of a two-consecutive-day, monthly dosing regimen (75mg on two consecutive days, monthly) of risedronate compared to a daily dosing regimen (5mg daily) of risedronate, by demonstrating the non-inferiority of the two-consecutive day, monthly regimen to the daily regimen assessed by percent change from baseline in lumbar spine bone mineral density (BMD) at 12 months in women with postmenopausal osteoporosis (PMO).

Locations

• , , UK

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