Skip to main content
OpenTrials
Completed

NCT Number: NCT00907296

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fracture Healing

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Geelong, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Romosozumab

Biological

Administered by subcutaneous injection

Other names: AMG 785, Evenity

Placebo

Drug

Administered by subcutaneous injection

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • UCB Pharma

Registry information

Official study 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

Acronym: STARTT

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
May 22, 2009
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.