ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

ClinicalTrials.gov ID: NCT01631214

Public ClinicalTrials.gov record NCT01631214. 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 May 17, 2026, 5:14 AM 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 Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Study identification

NCT ID
NCT01631214
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amgen
Industry
Enrollment
4,093 participants

Conditions and interventions

Interventions

  • Alendronate Drug
  • Placebo to Alendronate Drug
  • Placebo to Romosozumab Drug
  • Romosozumab Biological

Drug · Biological

Eligibility (public fields only)

Age range
55 Years to 90 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 3, 2012
Primary completion
Feb 26, 2017
Completion
Jun 28, 2017
Last update posted
Feb 20, 2025

2012 – 2017

United States locations

U.S. sites
32
U.S. states
20
U.S. cities
32
Facility City State ZIP Site status
Research Site Birmingham Alabama 35294
Research Site Peoria Arizona 85381
Research Site Phoenix Arizona 85037
Research Site Scottsdale Arizona 85258
Research Site Downey California 90242
Research Site Greenbrae California 94904
Research Site Los Angeles California 90057
Research Site South Lake Tahoe California 96150
Research Site Tustin California 92780
Research Site Walnut Creek California 94598
Research Site Lakewood Colorado 80227
Research Site Fort Lauderdale Florida 33309
Research Site Miami Florida 33136
Research Site Stuart Florida 34996
Research Site West Palm Beach Florida 33409
Research Site Gainesville Georgia 30501
Research Site Maywood Illinois 60153
Research Site Quincy Illinois 62301
Research Site Indianapolis Indiana 46202
Research Site Bethesda Maryland 20817
Research Site Boston Massachusetts 02114
Research Site Detroit Michigan 48236
Research Site St Louis Missouri 63110
Research Site Las Vegas Nevada 89148
Research Site Las Cruces New Mexico 88011
Research Site Great Neck New York 11021
Research Site Bismarck North Dakota 58503
Research Site Pittsburgh Pennsylvania 15213
Research Site Wyomissing Pennsylvania 19610
Research Site Richmond Virginia 23233
Research Site Port Angeles Washington 98362
Research Site Madison Wisconsin 53705

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 284 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01631214, 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 Feb 20, 2025 · Synced May 17, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01631214 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →