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Teriparatide Improves Quality of Life, Does Not Decrease Fractures in Women Older Than 80 Years of Age: Presented at ASBMR

By John Otrompke

DENVER -- September 18, 2009 -- Use of teriparatide by elderly women improves quality of life and reduces back pain, but does not decrease fracture risk, according to research discussed at the 31st Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).

"Most of these patients were severely osteoporotic, and most had been treated with other drugs in the past," described Fernando Marin, MD, PhD, Eli Lilly & Co., Windlesham, United Kingdom. "They switched from bisphosphonates for a variety of reasons -- including gastric problems, or because the patient didn't want to take the pill, or because they were still having fractures while they were on active therapy," said Dr. Marin, speaking at a poster presentation here on September 13. "We think there was a cumulative effect with teriparatide," he added.

The total population from which the subgroup of elderly women was drawn consisted of 1,648 women with a median age 71.5 years who were enrolled in the European Forsteo Observational Study (EFOS). Subjects were treated with teriparatide and followed for up to 18 months. At the follow-up visits, clinical vertebral and nonvertebral fragility fractures were collected, health-related quality-of-life was measured, and back pain was assessed using a 100-point visual analogue scale and a questionnaire.

In the total EFOS population, use of the drug was associated with a 47% decrease in the odds of fracture in the last 6-month period compared to the first 6-month period.

The same did not hold true, however of the 254 women aged 80 years or older (15.4%). In this group of women, fracture incidence was 4.3% in the first 6 months, 7.3% in the second 6 months, and 5.5% in the third 6 months. At least 1 new incident fracture was reported by 31 women (13.2%), and 31.4% of these were clinical vertebral fractures.

History of a prior fragility fracture was 94.7% in the group aged 80 years and older, and the prior use of antiresorptives was 92%, with both numbers being similar to the overall cohort.

"The change in fractures in the elderly group was not significant," said Dr. Marin. "The increased fracture rate during treatment was higher in this population than in those of a younger age, underlining the importance of treating the elderly," he added, noting that the findings could have been influenced by the small numbers in the elderly group within EFOS.

The very elderly patients, however, did report a decrease in back pain and improvement in quality of life after the first 3 months on teriparatide. More than 75% of the subjects aged 80 years or older reported back pain at the start of the trial, but the number decreased to 42.3% after 3 months, and by the end of the trial, it was 34%. At the start of the trial, 58.2% of the subjects aged 80 years or older reported severe back pain, but that number was down to 13.3% at the end of the trial at 18 months.

Funding for this study was provided by Eli Lilly and Company.

[Presentation title: Fracture Incidence, Quality of Life and Back Pain in Elderly Women With Osteoporosis Treated With Teriparatide: 18-Month Results From the European Forsteo Observational Study (EFOS). Abstract SU0356]

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