Newswise — Patients taking glucocorticoids (e.g., prednisone) sometimes suffer from a common side effect of the treatment: osteoporosis. Now, though, these patients may have a new option to prevent bone loss and fractures, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Francisco, Calif.
Osteoporosis is a silent disease of the bones that makes them weaken and prone to fracture. Bone is living tissue that is in a constant state of regeneration, as old bone is removed (bone resorption) and replaced by new bone (bone formation). Glucocorticoids are a commonly prescribed class of drugs used to treat a wide range of inflammatory diseases including rheumatoid arthritis and asthma. Glucocorticoids can interfere with normal bone turnover causing osteoporosis.
Researchers recently compared the effects of alendronate (FOSAMAX ®) and teriparatide (Forteo®) in patients who had taken glucocorticoids for at least three months. Two hundred and fourteen patients were randomly assigned to take 20 µg/day of teriparatide, and 214 patients were assigned to take 10 mg/day of alendronate. Both groups were followed for up to three years.
To track bone loss, researchers measured bone mass using dual energy X-ray absorptiometry, or DXA as it is commonly called, which is considered the gold standard in diagnosing osteoporosis as it is the easiest and best way to detect and track this initially silent disease over time.
Researchers found that both treatments resulted in improvements in bone mass; however, the increase in bone mass was greater in the teriparatide group at the lumbar spine and femoral neck, which are common sites for fractures in patients receiving glucocorticoids. They also noted that fewer patients experienced vertebral fractures in while taking teriparatide (1.7 percent) ¬" compared to those taking alendronate (7.7percent).
Additionally, the number of patients with new nonvertebral fractures was found to be similar in the two groups (7.5 percent of patients in the teriparatide group and seven percent of patients in the alendronate group). Researchers found that, in general, both drugs were well tolerated.
"Glucocorticoid-induced osteoporosis is commonly undetected and, even when considered, is often under-treated," explains Kenneth Saag, MD, MSc; professor of medicine and epidemiology; University of Alabama, Birmingham, Ala., and lead investigator in the study. "Results of this study suggest that teriparatide is an added treatment option for chronic glucocorticoid users at high risk for fractures."
Patients should talk to their rheumatologists to determine their best course of treatment.
The ACR is an organization of and for physicians, health professionals, and scientists that advances rheumatology through programs of education, research, advocacy and practice support that foster excellence in the care of people with or at risk for arthritis and rheumatic and musculoskeletal diseases. For more information on the ACR's annual meeting, see www.rheumatology.org/annual.
Editor's Notes: Dr. Saag will present this research during the ACR Annual Scientific Meeting at the Moscone Center from 11:00 " 11:15 AM on Wednesday, October 29, in Room 130. Dr. Saag will be available for media questions and briefing at 1:30 PM on Sunday, October 26 in the on-site press conference room, 114.
Presentation Number: 2101 Teriparatide versus Alendronate for Treatment of Glucocorticoid-Induced Osteoporosis: 36-month Results
Kenneth G. Saag1, Jose R. Zanchetta2, Jean-Pierre Devogelaer3, Robert A. Adler4, Richard Eastell5, Kyoungah See6, Gail P. Dalsky6, Kelly Krohn6, John H. Krege6, Margaret R. Warner6. 1University of Alabama at Birmingham, Birmingham, AL; 2Instituto de Investigaciones Metabólicas -IDIM, Buenos Aires, Argentina; 3Université catholique de Louvain, Brussels, Belgium; 4McGuire VA Medical Center, Richmond, VA; 5University of Sheffield, Sheffield, United Kingdom; 6Eli Lilly and Company, Indianapolis, IN
Purpose: This study compared the efficacy of teriparatide and alendronate in patients with glucocorticoid-induced osteoporosis (GIOP).
Methods: In a multicenter, double-blind, 36-month trial, patients who had taken glucocorticoids for ≥3 months (prednisone equivalent ≥5 mg/day) (18 month results: Saag et al. N Engl J Med 2007) were randomly assigned to teriparatide 20 µg/day (n=214) or alendronate 10 mg/day (n=214). Bone mineral density (BMD) was measured by dual energy x-ray absorptiometry. Markers of bone formation (N-terminal propeptide of type I collagen, PINP; bone-specific alkaline phosphatase, bone ALP; C-terminal propeptide of type I collagen, PICP; osteocalcin, OC) and resorption (C-telopeptide of type I collagen, CTX) were measured in 198 patients. BMD was analyzed using a Mixed Model Repeated Measures, markers by the Wilcoxon Rank Sum Test.
Results: Median baseline glucocorticoid dose was 7.5 mg/d. Mean percent increase in BMD was significantly greater in the teriparatide than the alendronate group at the lumbar spine and femoral neck (Table). In the alendronate group, median concentrations of PINP, bone ALP, PICP, OC, and CTX were significantly decreased by 1 or 6 mos, and all but bone ALP remained significantly lower than baseline through 36 mo. In the teriparatide group, median concentrations of PINP, bone ALP, and OC were significantly increased through 36 months. PICP and CTX levels were significantly increased at 1 mo; CTX was also elevated above baseline at 6 mo. Fewer patients had new radiographic vertebral fractures in teriparatide (3/173, 1.7%) than alendronate group (13/169, 7.7%; p=0.007). The number of patients with new nonvertebral fractures was not significantly different between groups (teriparatide 16/214, 7.5%; alendronate 15/214, 7.0%; p=0.843). There was no significant difference in the number of patients with ≥1 adverse event (91% teriparatide vs. 86% alendronate, p=0.116). Hypercalcemia was reported as an adverse event in 1 patient in the teriparatide group and none in the alendronate group.
Conclusions: Both treatments were generally well tolerated. In this 36-month trial of GIOP, patients treated with teriparatide had greater increases in BMD and fewer new vertebral fractures compared with patients treated with alendronate.
[Table included with press release and full abstract at www.rheumatology.org.]
Disclosure Block: K.G. Saag, Eli Lilly and Company, 2; Merck and Company, 2; Aventis, 2; Amgen, 2; Roche, 2; GlaxoSmithKline, 2; Eli Lilly and Company, 5; Merck and Company, 5; Novartis, 5; Roche, 5; Amgen, 5; Merck and Company, 8; Novartis, 8; J.R. Zanchetta, Wyeth, 2; Amgen, 2; GlaxoSmithKline, 2; Merck, 2; Eli Lilly and Company, 2; Sanofi-Aventis, 2; Pfizer, 2; Roche, 2; Servier, 2; Eli Lilly and Company, 5; Sanofi-Aventis, 5; GlaxoSmithKline, 5; Merck, 5; Wyeth, 5; Amgen, 5; Pfizer, 5; Roche, 5; Servier, 5; J. Devogelaer, Eli Lilly and Company, 2; Novartis, 8; Procter & Gamble, 8; Servier, 8; Roche, 8; GlaxoSmithKline, 8; Merck, 8; Novartis, 9; R.A. Adler, None; R. Eastell, Eli Lilly and Company, 2; Eli Lilly and Company, 5; Eli Lilly and Company, 8; K. See, Eli Lilly and Company, 3; G.P. Dalsky, Eli Lilly and Company, 3; K. Krohn, Eli Lilly and Company, 3; J.H. Krege, Eli Lilly and Company, 3; M.R. Warner, Eli Lilly and Company, 3.
RSS