Format

Send to

Choose Destination
Calcif Tissue Int. 2018 Oct 20. doi: 10.1007/s00223-018-0485-2. [Epub ahead of print]

Reduction of Hip and Other Fractures in Patients Receiving Teriparatide in Real-World Clinical Practice: Integrated Analysis of Four Prospective Observational Studies.

Author information

1
Cedars-Sinai Medical Center, David Geffen School of Medicine, UCLA, and OMC Clinical Research Center, 8641 Wilshire Blvd, Suite 301, Beverly Hills, CA, 90211, USA. stuarts@omcresearch.org.
2
Arhus University Hospital, Aarhus, Denmark.
3
Department of Pharmacy, Yasuda Women's University, Hiroshima, Japan.
4
University of Alabama at Birmingham, Birmingham, AL, USA.
5
University Campus Bio-Medico, Rome, Italy.
6
Istituto Ortopedico Galeazzi, Milan, Italy.
7
Department of Orthopaedic Surgery and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan.
8
Eli Lilly Japan K.K., Kobe, Japan.
9
Syneos Health, Raleigh, NC, USA.
10
Eli Lilly and Company, Indianapolis, IN, USA.
11
Lilly Research Centre, Windlesham, UK.

Abstract

The phase 3 teriparatide Fracture Prevention Trial showed significant reductions in vertebral (VF) and nonvertebral (NVF) fractures; however, patient exposure was insufficient for full analysis of low-incidence fractures, including hip. We assessed fracture results in pooled data from four prospective, observational teriparatide studies. Ambulatory women and men with osteoporosis received subcutaneous teriparatide 20 µg/day for up to 24 months per routine clinical practice. Fracture rates were compared between 6-month periods, using 0 to 6 months of treatment as the reference period. Analyses used a piecewise exponential model for first fracture. Hip, NVF, clinical VF (CVF), any clinical, and wrist fractures were assessed. For 8828 patients analyzed, mean age was 71 years; mean (SD) treatment duration was 17.4 (8.6) months. The rate of hip fracture decreased significantly for the > 12 to 18-month (- 47.7%) and > 18-month periods (-85.2%) versus the first 6 months of therapy, and for the > 18 versus the > 6 to 12-month period. NVF, CVF, and all clinical fractures were all significantly decreased in each post-reference period, with maximum decreases (> 18-month period) of 52.7%, 69.4%, and 61.2%, respectively, versus 0 to 6 months. No significant reduction was seen for rates of wrist fracture. Teriparatide treatment was associated with statistically significant decreases in hip fracture rate, particularly for > 18 months of treatment, and in NVF, CVF, and all clinical fracture rate in real-world patients. These results should be interpreted in the context of the non-controlled design of the source studies.

KEYWORDS:

Anabolic; Fracture; Observational study; Teriparatide

PMID:
30343436
DOI:
10.1007/s00223-018-0485-2

Supplemental Content

Full text links

Icon for Springer
Loading ...
Support Center