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

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ClinicalTrials.gov Identifier: NCT00907296
Recruitment Status : Completed
First Posted : May 22, 2009
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Amgen

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Fracture Healing Biological: Romosozumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2, 2009
Actual Primary Completion Date : March 6, 2012
Actual Study Completion Date : May 10, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. Number of Participants With Unplanned Revision Surgeries [ Time Frame: 52 weeks ]
  3. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907296


  Show 103 Study Locations
Sponsors and Collaborators
Amgen
UCB Pharma
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00907296     History of Changes
Other Study ID Numbers: 20062017
2008-008392-34 ( EudraCT Number )
First Posted: May 22, 2009    Key Record Dates
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019
Last Verified: March 2019
Keywords provided by Amgen:
Fracture Healing
Tibial Diaphyseal Fracture
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs