An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women (STRUCTURE)

November 4, 2022 updated by: Amgen

An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With Romosozumab in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy

The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
436

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
        • Research Site
    • Córdoba
      • Cordoba, Córdoba, Argentina, X5000BNB
        • Research Site
  • Belgium
      • Genk, Belgium, 3600
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liege 1, Belgium, 4000
        • Research Site
  • Canada
      • Quebec, Canada, G1V 3M7
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3X8
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Research Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Research Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Research Site
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 08001000
        • Research Site
  • Czechia
      • Brno, Czechia, 602 00
        • Research Site
      • Ostrava 1, Czechia, 702 00
        • Research Site
      • Plzen, Czechia, 305 99
        • Research Site
      • Praha 11 - Chodov, Czechia, 148 00
        • Research Site
      • Uherske Hradiste, Czechia, 686 01
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Aarhus C, Denmark, 8000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
      • Esbjerg, Denmark, 6700
        • Research Site
      • Hillerød, Denmark, 3400
        • Research Site
      • Hvidovre, Denmark, 2650
        • Research Site
      • Odense, Denmark, 5000
        • Research Site
  • Hungary
      • Budapest, Hungary, 1083
        • Research Site
      • Budapest, Hungary, 1036
        • Research Site
      • Budapest, Hungary, 1123
        • Research Site
  • Poland
      • Gdynia, Poland, 81-384
        • Research Site
      • Katowice, Poland, 40-040
        • Research Site
      • Warszawa, Poland, 01-192
        • Research Site
      • Wroclaw, Poland, 50-088
        • Research Site
  • Spain
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
    • Andalucía
      • Granada, Andalucía, Spain, 18012
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08041
        • Research Site
      • LHospitalet de Llobregat, Cataluña, Spain, 08907
        • Research Site
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Research Site
  • United Kingdom
      • Cardiff, United Kingdom, CF14 5GJ
        • Research Site
      • Chorley, United Kingdom, PR7 7NA
        • Research Site
      • Liverpool, United Kingdom, L22 0LG
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Research Site
      • Reading, United Kingdom, RG2 0TG
        • Research Site
      • Sidcup, United Kingdom, DA14 6LT
        • Research Site
  • United States
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Research Site
      • Boston, Massachusetts, United States, 02131
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women, aged ≥ 55 to ≤ 90.
  • Received oral bisphosphonate therapy for at least 3 years immediately prior to screening
  • BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck
  • History of nonvertebral fracture after age 50, or vertebral fracture.

Exclusion Criteria:

  • Use of other agents affecting bone metabolism including Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH) analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids:
  • History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.
  • Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as determined by the central laboratory.
  • Current hyper- or hypocalcemia
  • Current, uncontrolled hyper- or hypothyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Romosozumab
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Drug: Romozosumab
Administered by subcutaneous injection once a month.
Other Names:
  • AMG 785
Active Comparator: Teriparatide
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
Drug: Teriparatide
Administered by subcutaneous injection once a day.
Other Names:
  • Forteo
  • Forsteo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)
Time Frame: Baseline, month 6 and month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.
Baseline, month 6 and month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Total Hip BMD at Month 6
Time Frame: Baseline and month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Baseline and month 6
Percent Change From Baseline in Total Hip BMD at Month 12
Time Frame: Baseline and month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Baseline and month 12
Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6
Time Frame: Baseline and month 6
Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.
Baseline and month 6
Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12
Time Frame: Baseline and month 12
Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.
Baseline and month 12
Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6
Time Frame: Baseline and month 6
Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.
Baseline and month 6
Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12
Time Frame: Baseline and month 12
Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.
Baseline and month 12
Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6
Time Frame: Baseline and month 6
Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.
Baseline and month 6
Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12
Time Frame: Baseline and month 12
Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.
Baseline and month 12
Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6
Time Frame: Baseline and month 6
Total hip integral BMC was measured using quantitative computed tomography (QCT).
Baseline and month 6
Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12
Time Frame: Baseline and month 12
Total hip integral BMC was measured using quantitative computed tomography (QCT).
Baseline and month 12
Percent Change From Baseline in Femoral Neck BMD at Month 6
Time Frame: Baseline and month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Baseline and month 6
Percent Change From Baseline in Femoral Neck BMD at Month 12
Time Frame: Baseline and month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Baseline and month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Time Frame: Baseline and month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Baseline and month 6
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Time Frame: Baseline and month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Baseline and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20080289
  • 2012-002948-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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