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