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NCT00172107 · ClinicalTrials.gov registry record · Phase 2

A Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 (50, 75, and 100µg) in the Treatment of Postmenopausal Osteoporosis

A Phase 2 study, sponsored by Shire.

Completed
Registry status
Phase 2
Development phase
217
Enrollment target

NCT00172107 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 217 participants.

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The verdict

NCT00172107, a Phase 2 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 2
Development phase
217 participants
Enrollment target

Study Summary

A double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of 3 doses of ALX1-11 (recombinant human parathyroid hormone \[rhPTH(1-84)\])(50, 75 and 100 µg) in the treatment of postmenopausal osteoporosis. The primary objective of this study is to compare the efficacy of ALX1-11 (50, 75 and 100 µg) with that of placebo in terms of increasing vertebral bone mineral density, when given daily by subcutaneous injection for 12 months in postmenopausal women with osteoporosis.

Interventions

  • DRUG placebo
  • DRUG ALX1-11 50 mcg
  • DRUG ALX1-11 75mcg
  • DRUG ALX1-11

Trial Details

FieldValue
Enrollment Target 217 participants
Start Date 1995-05-18
Est. Completion 1997-03-24
Phase Phase 2

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00172107

The ClinicalTrials.gov registry entry for NCT00172107 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 217 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.

NCT00172107 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00172107 about?

NCT00172107 is a clinical study titled "A Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 (50, 75, and 100µg) in the Treatment of Postmenopausal Osteoporosis". A double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of 3 doses of ALX1-11 (recombinant human parathyroid hormone \[rhPTH(1-84)\])(50, 75 and 100 µg) in the treatment of postmenopausal osteoporosis. The primary objective of this study is to compare the efficacy ...

What is the current status of trial NCT00172107?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 1995-05-18. Estimated completion is 1997-03-24.

What interventions are being tested in trial NCT00172107?

The interventions under investigation include: placebo (DRUG), ALX1-11 50 mcg (DRUG), ALX1-11 75mcg (DRUG), ALX1-11 (DRUG).

Who is sponsoring clinical trial NCT00172107?

This trial is sponsored by Shire, which has 245 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.