CoChat
Sign Up
Cited by 57Bone fractures and treatmentsBone health and osteoporosis researchHip and Femur Fractures

Clinical evaluation of medicinal products for acceleration of fracture healing in patients with osteoporosis

Open access
Goldhahn, Jörg, Scheele, Wim H., Mitlak, Bruce H., Abadie, Eric, Aspenberg, Per, Augat, Peter, Brandi, Maria-Luisa, Burlet, Nansa +16 more·2008·Bone
DOI 10.1016/j.bone.2008.04.017
Open this paper in CoChat — free account

Abstract

Pre-clinical studies indicate that pharmacologic agents can augment fracture union. If these pharmacologic approaches could be translated into clinical benefit and offered to patients with osteoporosis or patients with other risks for impaired fracture union (e.g. in subjects with large defects or open fractures with high complication rate), they could provide an important adjunct to the treatment of fractures. However, widely accepted guidelines are important to encourage the conduct of studies to evaluate bioactive substances, drugs, and new agents that may promote fracture union and subsequent return to normal function. A consensus process was initiated to provide recommendations for the clinical evaluation of potential therapies to augment fracture repair in patients with meta- and diaphyseal fractures. Based on the characteristics of fracture healing and fixation, the following study objectives of a clinical study may be appropriate: a) acceleration of fracture union, b) acceleration of return to normal function and c) reduction of fracture healing complications. The intended goal(s) should determine subsequent study methodology. While an acceleration of return to normal function or a reduction of fracture healing complications in and of themselves may be sufficient primary study endpoints for a phase 3 pivotal study, acceleration of fracture union alone is not. Radiographic evaluation may either occur at multiple time points during the healing process with the aim of measuring the time taken to reach a defined status (e.g. cortical bridging of three cortices or disappearance of fracture lines), or could be obtained at a single pre-determined timepoint, were patients are expected to reach a common clinical milestone (i.e. pain free full weight-bearing in weight-bearing fracture cases). Validated Patient Reported Outcomes (PRO's) measures will need to support the return to normal function co-primary endpoints. If reduction of complication rate (e.g. non-union) is the primary objective, the anticipated complications must be defined in the study protocol, along with their possible associations with the specified fracture type and fixation device. The study design should be randomized, parallel, double-blind, and placebo-controlled, and all fracture subjects should receive a standardized method of fracture fixation, defined as Standard of Care.

Integrity signals

Registry

Crossref · 10.1016/j.bone.2008.04.017

Cites

19 of 19 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

We couldn’t retrieve this paper’s full text, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
Goldhahn, J., Scheele, W. H., Mitlak, B. H., Abadie, E., Aspenberg, P., Augat, P., Brandi, M.-L., Burlet, N., Chines, A., Delmas, P. D., Dupin-Roger, I., Ethgen, D., Hanson, B., Hartl, F., Kanis, J. A., Kewalramani, R., Laslop, A., Marsh, D., Ormarsdottir, S., Rizzoli, R., Santora, A., Schmidmaier, G., Wagener, M., & Reginster, J.-Y.
Affiliations
  • AO Foundation (CH)
  • Eli Lilly (United States) (US)
  • Linköping University (SE)
  • Paracelsus Medical University (AT)
  • University of Florence (IT)
  • International Osteoporosis Foundation (CH)
  • Hôpital Edouard Herriot (FR)
  • GlaxoSmithKline (United States) (US)
  • F. Hoffmann-La Roche AG (CH)
  • Amgen (United States) (US)
  • Austrian Agency for Health and Food Safety (AT)
  • Queen's University Belfast (GB)
  • European Organization for Nuclear Research (CH)
  • Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
  • Charité – Universitätsmedizin Berlin (DE)
  • Novartis (Switzerland) (CH)
  • University of Liège (BE)
Corresponding author
Goldhahn, Jörg
ORCID
Venue
Bone
Publisher
Elsevier BV
Published
2008-08
Volume
43
Issue
2
Pages
343-347
ISSN
  • 1873-2763 (ISSN-L)
  • 8756-3282
DOI
10.1016/j.bone.2008.04.017
OpenAlex
W2103905415
Cited by
57
References
19
Citations by year
2026: 1 · 2025: 1 · 2024: 1 · 2022: 3 · 2021: 1 · 2020: 3 · 2019: 3 · 2018: 2 · 2017: 7 · 2015: 4 · 2014: 6 · 2013: 9 · 2012: 6
FWCI
2.47
Type
journal article
Language
en
Open access
Licence
Locations
  • Bone (publishedVersion)
  • PubMed (publishedVersion)
  • Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
  • Research Bank (Australian Catholic University) (submittedVersion)
  • UCL Discovery (University College London) (submittedVersion)
  • Florence Research (University of Florence) (submittedVersion)
  • Open Repository and Bibliography (University of Liège) (submittedVersion)
Topics
  • Health Sciences › Medicine › Epidemiology › Bone fractures and treatments
  • Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
  • Health Sciences › Medicine › Surgery › Hip and Femur Fractures
Keywords
fracture healing, osteoporosis, fracture fixation, nonunion, patient-reported outcomes, clinical trial design, consensus recommendations
MeSH terms
Clinical Trials as Topic, Drug Evaluation, Preclinical, Pharmaceutical Preparations, Humans, Osteoporosis, Treatment Outcome, Fracture Healing

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review