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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: Completed Phase 2 study, sponsored by Shire.

NCT00172107 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 217 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.

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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
Shire

245 total trials

What the finished NCT00172107 record still lists

NCT00172107 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher).

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

NCT00172107 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00172107's enrollment target sits among peer trials

217 286th of 2000 higher than 1,715 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00172107, the US trial registry maintained by the National Library of Medicine. NCT00172107 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.