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NCT00358176 · ClinicalTrials.gov registry record · Phase 3

Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
1,231
Enrollment target

NCT00358176 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,231 participants.

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The verdict

NCT00358176, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
1,231 participants
Enrollment target

Study Summary

To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption. To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.

Interventions

  • DRUG Risedronate (HMR4003)

Trial Details

FieldValue
Enrollment Target 1,231 participants
Start Date 2004-07
Est. Completion 2007-03
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00358176

The ClinicalTrials.gov registry entry for NCT00358176 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,231 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Risedronate (HMR4003) is the first listed.

NCT00358176 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00358176 about?

NCT00358176 is a clinical study titled "Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women". To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 co...

What is the current status of trial NCT00358176?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,231 participants. The study started on 2004-07. Estimated completion is 2007-03.

What interventions are being tested in trial NCT00358176?

The interventions under investigation include: Risedronate (HMR4003) (DRUG).

Who is sponsoring clinical trial NCT00358176?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.