Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing (STARTT)

September 9, 2022 updated by: Amgen

A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail

The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

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.
402

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 2

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

  • Australia
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Research Site
      • Parkville, Victoria, Australia, 3050
        • Research Site
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Research Site
      • Pleven, Bulgaria, 5800
        • Research Site
      • Plovdiv, Bulgaria, 4002
        • Research Site
      • Ruse, Bulgaria, 7000
        • Research Site
      • Sofia, Bulgaria, 1527
        • Research Site
  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T4N 6V7
        • Research Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Research Site
      • Thunder Bay, Ontario, Canada, P7B 7C7
        • Research Site
      • Toronto, Ontario, Canada, M5C 1R6
        • Research Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Research Site
      • Windsor, Ontario, Canada, N9A 1E1
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
      • Montreal, Quebec, Canada, H3G 1A4
        • Research Site
  • Denmark
      • Hvidovre, Denmark, 2650
        • Research Site
      • København NV, Denmark, 2400
        • Research Site
      • Ã…rhus C, Denmark, 8000
        • Research Site
  • Estonia
      • Tallinn, Estonia, 11312
        • Research Site
      • Tartu, Estonia, 50410
        • Research Site
  • France
      • Lille, France, 59000
        • Research Site
      • Marseille, France, 13009
        • Research Site
      • Nantes Cedex 1, France, 44035
        • Research Site
      • Paris Cedex 12, France, 75571
        • Research Site
  • Germany
      • Aachen, Germany, 52074
        • Research Site
      • Hamburg, Germany, 20246
        • Research Site
      • Hannover, Germany, 30625
        • Research Site
      • Mannheim, Germany, 68165
        • Research Site
      • Muenster, Germany, 48149
        • Research Site
  • Greece
      • Athens, Greece, 12462
        • Research Site
      • Athens, Greece, 14561
        • Research Site
      • Larissa, Greece, 41110
        • Research Site
      • Patra, Greece, 26500
        • Research Site
      • Thessaloniki, Greece, 56429
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • New Territories, Hong Kong
        • Research Site
  • Hungary
      • Budapest, Hungary, 1081
        • Research Site
      • Miskolc, Hungary, 3526
        • Research Site
      • Nyiregyhaza, Hungary, 4400
        • Research Site
      • Szeged, Hungary, 6725
        • Research Site
  • India
      • Gandhinagar, India, 382 428
        • Research Site
      • Mangalore, India, 575 001
        • Research Site
      • Nashik, India, 422 009
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 054
        • Research Site
      • Bangalore, Karnataka, India, 560 034
        • Research Site
      • Mangalore, Karnataka, India, 575 002
        • Research Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 005
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302 022
        • Research Site
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625 020
        • Research Site
  • Italy
      • Firenze, Italy, 50139
        • Research Site
      • Milano, Italy, 20122
        • Research Site
      • Milano, Italy, 20142
        • Research Site
      • Pisa, Italy, 56126
        • Research Site
      • Roma (RM), Italy, 00133
        • Research Site
      • Verona, Italy, 37126
        • Research Site
  • Latvia
      • Liepaja, Latvia, 3400
        • Research Site
      • Riga, Latvia, 1004
        • Research Site
      • Riga, Latvia, 1005
        • Research Site
      • Valmiera, Latvia, 4201
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, 44320
        • Research Site
      • Vilnius, Lithuania, 04130
        • Research Site
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64040
        • Research Site
  • New Zealand
      • Christchurch, New Zealand, 8022
        • Research Site
      • Tauranga, New Zealand, 3143
        • Research Site
  • Norway
      • Kongsvinger, Norway, 2226
        • Research Site
  • Poland
      • Bialystok, Poland, 15-276
        • Research Site
      • Bytom, Poland, 41-902
        • Research Site
      • Krakow, Poland, 30-901
        • Research Site
      • Kraków, Poland, 31-826
        • Research Site
      • Lublin, Poland, 20-718
        • Research Site
  • Romania
      • Bucharest, Romania, 014461
        • Research Site
      • Bucuresti, Romania, 050098
        • Research Site
      • Timisoara, Romania, 300736
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation, 129327
        • Research Site
      • Moscow, Russian Federation, 115280
        • Research Site
      • Moscow, Russian Federation, 117292
        • Research Site
      • Moscow, Russian Federation, 127299
        • Research Site
      • Moscow, Russian Federation, 119049
        • Research Site
      • Saint Petersburg, Russian Federation, 196247
        • Research Site
      • Yaroslavl, Russian Federation, 150003
        • Research Site
  • Slovakia
      • Bratislava, Slovakia, 833 05
        • Research Site
      • Nitra, Slovakia, 950 01
        • Research Site
      • Piestany, Slovakia, 921 01
        • Research Site
  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • Research Site
      • London, United Kingdom, E1 1BB
        • Research Site
      • Newcastle, United Kingdom, NE1 4LP
        • Research Site
      • Norwich, United Kingdom, NR4 7UY
        • Research Site
      • Oxford, United Kingdom, OX3 9DU
        • Research Site
      • Stanmore, United Kingdom, HA7 4LP
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
    • California
      • Orange, California, United States, 92868
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Research Site
      • Denver, Colorado, United States, 80204
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • New York
      • Brooklyn, New York, United States, 11220
        • Research Site
      • Rochester, New York, United States, 14642
        • Research Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Research Site
    • Utah
      • Sandy, Utah, United States, 84070
        • 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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates
  • Fresh unilateral closed or Gustilo type I or type II open tibial fracture
  • Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing

Exclusion Criteria:

  • Major polytrauma or significant axial trauma
  • Associated lower extremity fracture that will delay subject's ability to bear weight beyond the normal time expected for a tibial shaft fracture
  • Use of bone grafts at the time of fracture fixation
  • Pathological fracture or metabolic or bone disease
  • History of symptomatic spinal stenosis or facial nerve paralysis
  • Malignancy within the last 5 years
  • Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia
  • Use of agents affecting bone metabolism
  • Subject refuses to use appropriate methods of contraception

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
  • Masking: QUADRUPLE

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.
PLACEBO_COMPARATOR: Placebo
Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
Drug: Placebo
Administered by subcutaneous injection
EXPERIMENTAL: Romosozumab 70 mg: 2 Doses
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Biological: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • Evenity
EXPERIMENTAL: Romosozumab 70 mg: 3 Doses
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Biological: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • Evenity
EXPERIMENTAL: Romosozumab 70 mg: 4 Doses
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
Biological: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • Evenity
EXPERIMENTAL: Romosozumab 140 mg: 2 Doses
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Biological: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • Evenity
EXPERIMENTAL: Romosozumab 140 mg: 3 Doses
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Biological: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • Evenity
EXPERIMENTAL: Romosozumab 140 mg: 4 Doses
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
Biological: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • Evenity
EXPERIMENTAL: Romosozumab 210 mg: 2 Doses
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Biological: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • Evenity
EXPERIMENTAL: Romosozumab 210 mg: 3 Doses
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Biological: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • Evenity
EXPERIMENTAL: Romosozumab 210 mg: 4 Doses
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
Biological: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • Evenity

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
Time to Radiographic Healing
Time Frame: 52 weeks

Time to radiographic healing was defined as the time from intramedullary (IM) nailing to the first occurrence of bridging of 3 out of 4 cortices. Radiographic fracture healing was determined by a panel of independent reviewers (orthopedic/trauma surgeons and radiologists) blinded to treatment.

The cumulative incidence function (CIF) method was used to estimate the median time to radiographic healing and the confidence intervals. Unplanned revision surgery to promote healing was considered a competing risk in CIF estimate.
52 weeks

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
Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain
Time Frame: Week 8 and weeks 12, 16, 20, 24, 36, and 52

The Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2, is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical functioning domain includes 10 questions that assess limitations in physical activities because of health problems.

Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. The range of SF-36 physical functioning is 14.94 - 57.03. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement in physical functioning.
Week 8 and weeks 12, 16, 20, 24, 36, and 52
Number of Participants With Unplanned Revision Surgeries
Time Frame: 52 weeks
52 weeks
Time to Clinical Healing
Time Frame: 52 weeks

Time to clinical healing was defined as the time from the IM nailing surgery date to the first date that both the score for ability to bear weight on the fractured limb and the score for absence of pain at the fracture site were equal to 6.

The score for the ability to bear weight on the fractured limb was based on the ability to stand on affected leg without assistive device and the ability to walk without assistive device. The score ranges from 0 (unable to bear full body weight on the fractured limb) to 6 (able to bear full body weight on the fractured limb). Absence of pain at the fracture site was based on the absence of pain at the fracture site when applying direct pressure to the fracture site and applying a stress to the fracture site. The score ranges from 0 (pain without palpation at fracture site) to 6 (total absence of pain at fracture site).

Time to clinical healing was estimated using CIF; unplanned revision surgery was considered a competing risk in CIF estimate.
52 weeks

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UCB Pharma

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.
September 2, 2009

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.
March 6, 2012

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 10, 2013

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).
May 21, 2009

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.
May 21, 2009

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.
May 22, 2009

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.
September 22, 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.
September 9, 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.
September 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.
  • 20062017
  • 2008-008392-34 (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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