Teriparatide Reduces Fractures, Back Pain, Improves QoL in Women With Severe Osteoporosis

Alice Goodman

June 21, 2010

June 21, 2010 (Rome, Italy) — Teriparatide (Forsteo in Europe, Forteo in the United States; Lilly) significantly reduced the incidence of new fractures in postmenopausal women with severe osteoporosis and a history of fractures, according to the 36-month results from the European Forsteo Observational Study (EFOS), a large "real world" open-label study reported here at the European League Against Rheumatism Congress 2010 by lead author Willem Lems, MD, professor of rheumatology at the University Medical Center in Amsterdam, the Netherlands.

Teriparatide users also reported a large reduction in back pain and improved quality of life.

"The results of this study are exciting for practitioners and for elderly women with severe osteoporosis," said Dr. Lems. He pointed out that the women in this study had significant comorbidities. Previously, studies involved only otherwise healthy patients with osteoporosis. "This makes the results clinically applicable to the types of patients we see in clinical practice," he said.

EFOS enrolled 1645 postmenopausal women with severe osteoporosis from 8 European countries. Almost 100% were Caucasian, mean age was 71 years, and the mean number of fractures at entry was 2.9.

Women were treated with daily injections of teriparatide for 18 months and then followed for an additional 18 months. "It is uncommon in clinical trials of osteoporosis drugs to follow patients after treatment is stopped, so this represents a real-world situation," Dr. Lems noted.

"Of these women, 73.8% had sustained 2, 3, 4, or 5 fractures by age 40 at baseline, which makes our findings especially important," Dr. Lems stated. "These women had a long list of comorbidities, and all of them would have been excluded from phase 3 trials."

"They were taking lots of different drugs for their comorbidities, and many of these drugs can increase the risk of falls and therefore . . . fractures," he added.

Patients were assessed every 6 months over a 36-month period. A total of 208 women (13.2%) sustained 258 fractures during follow-up. Of these, 34% were vertebral and 66% nonvertebral. The risk for fracture was highest in the first 6 months and decreased thereafter. From 0 to 6 months, the incidence of fracture was 4.8%; the risk reduced over time to 1.3% at the 30- to 36-month time point, which represents a 73% risk reduction from baseline (P < .001), Dr. Lems announced.

"The fracture risk continued to get lower over time, even after teriparatide was stopped. About two thirds of the women went on to take bisphosphonates after teriparatide was stopped," he said.

Back pain, assessed using a visual analog scale, was also significantly reduced from baseline at all time points during and after therapy (P < .001). Quality of life, assessed by EQ-5D (formerly called EuroQol), also improved significantly over time, compared with baseline (P < .001).

"As a clinician, you see patients who don't like the idea of daily injections. Once these women had pain relief, they were happy to take the injections," Dr. Lems said.

Piet Geusens, MD, professor of rheumatology at the University of Maastricht in the Netherlands and the University of Hasselt in Belgium, said that the results of EFOS are impressive. "For the first time, we have a drug that can build bone. Other drugs for osteoporosis work by an antiresorptive mechanism."

He said that his clinical experience with this drug mirrors the study results. His patients treated with teriparatide have relief of back pain and improved quality of life and are grateful for the daily injections.

Dr. Geusens said that teriparatideshould be used to treat severe osteoporosis in women who continue to sustain fractures despite first-line treatment.

Dr. Lems reports financial ties with Eli Lilly (marketers of teriparatide), Novartis, MSD, Servier, and Amgen. Dr. Geusens reports receiving grant/research support from Merck, Roche, Servier, P&G, Wyeth, Schering-Plough, Amgen, Lilly, GSK, Novartis, Abbott, and Pfizer.

European League Against Rheumatism (EULAR) Congress 2010: Abstract OP0058. Presented June 18, 2010.


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