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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00172107

Public ClinicalTrials.gov record NCT00172107. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 6:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00172107
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Shire
Industry
Enrollment
217 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
50 Years to 75 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 17, 1995
Primary completion
Mar 23, 1997
Completion
Mar 23, 1997
Last update posted
May 16, 2021

1995 – 1997

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
Pivotal Research Peoria Arizona 85381
Loma Linda Osteoporosis Research Clinic Loma Linda California 92354
Steven Harris Mill Valley California 94941
John Wayne Cancer Institute Santa Monica California 90404
Paul Miller Lakewood Colorado 80227
Longmont Medical Research Network Longmont Colorado 80501
Radiant Research, Stuart Stuart Florida 34996
Maine Center for Osteoporosis Research and Education of St. Joseph's Hospital Bangor Maine 04401
'Bethesda Health Research Center Bethesda Maryland 20817
Helen Hayes Hospital West Haverstraw New York 10993
Oregon Osteoporosis Center Portland Oregon 97213
Simona Scumpia Austin Texas 78758
Radiant Research, Dallas Dallas Texas 75235
'Diabetes & Glandular Disease Research Associates, P.A. San Antonio Texas 78229
Northwest Lipid Research Center Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00172107, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 16, 2021 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00172107 live on ClinicalTrials.gov.

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