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NCT00130403 · ClinicalTrials.gov registry record · Phase 4

OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women

A Phase 4 study, sponsored by Sanofi.

Completed
Registry status
Phase 4
Development phase
290
Enrollment target

NCT00130403: Completed Phase 4 study, sponsored by Sanofi.

NCT00130403 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 290 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00130403, a Phase 4 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 4
Development phase
290 participants
Enrollment target

Study Summary

To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH\[1-34\])-associated change from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP), between subjects previously treated with risedronate and those previously treated with alendronate.

Interventions

  • DRUG risedronate sodium

Trial Details

FieldValue
Enrollment Target 290 participants
Start Date 2004-03
Est. Completion 2007-03
Phase Phase 4
Sanofi

713 total trials

What the finished NCT00130403 record still lists

NCT00130403 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower).

The record links to 0 conditions, and to 1 intervention - of which risedronate sodium is the first listed.

NCT00130403 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00130403 about?

NCT00130403 is a clinical study titled "OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women". To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH\[1-34\])-associated change from baseline in a mark...

What is the current status of trial NCT00130403?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 290 participants. The study started on 2004-03. Estimated completion is 2007-03.

What interventions are being tested in trial NCT00130403?

The interventions under investigation include: risedronate sodium (DRUG).

Who is sponsoring clinical trial NCT00130403?

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

How this trial's enrollment target compares

Where NCT00130403's enrollment target sits among peer trials

290 297th of 2000 higher than 1,703 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00130403, the US trial registry maintained by the National Library of Medicine. NCT00130403 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.