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Investigators in Greece, Germany and the United States have published new osteoporosis data.
Study 1: Raloxifene therapy does not reduce back pain in postmenopausal women with osteoporosis.
According to recent research published in the European Spine Journal, "Clinical studies have suggested that postmenopausal women on estrogen replacement treatment are more likely to experience back pain and related disability compared to women who do not take estrogens."
"Raloxifene, a selective estrogen receptor modulator has estrogen-like effects on bone tissue, and antagonizes the action of estrogens on endometrium and breast tissue. It is unknown if the treatment of osteoporosis with raloxifene has estrogen-like or opposite effects on back pain and functional capacity among postmenopausal women with osteoporosis," wrote G. Papadokostakis and colleagues of the University General Hospital in Crete.
The investigators described their study, "A total of 120 postmenopausal women with osteoporosis and chronic back pain were randomized to receive raloxifene 60 mg with 1,000 mg calcium, and 800 IU vitamin D daily or 1,000 mg calcium and 800 IU vitamin D daily. Pain intensity and pain-related disability were measured before treatment at 6 months and after 1 year."
"Repeated measures of ANOVA, did not reveal statistically significant differences over time, on pain intensity and disability scores, between groups studied," they determined. "There was a trend in pain intensity changes during the follow-up period, but the differences between the groups were not statistically significant."
The authors concluded, "It seems that treatment with raloxifene does not influence back pain and disability among postmenopausal women with osteoporosis. Raloxifene may have estrogenic agonist effects on nociceptive processing in the central nervous system."
Papadokostakis and colleagues published their study in European Spine Journal (Does raloxifene treatment influence back pain and disability among postmenopausal women with osteoporosis? Eur Spine J, 2005;14(10):977-981).
For additional information, contact A. Hadjipavlou, Department of Orthopaedic Surgery and Traumatology, University General Hospital, Heraklio, Crete, Greece. Email: ahadjipa@med.uoc.gr.
Study 2: Etidronate and sequential monofluorophosphate has potential as therapy for severe osteoporosis in postmenopausal women.
"In a 3-year pilot study on 52 women with severe postmenopausal osteoporosis, treatment with etidronate followed by calcium and vitamin D (ECaD) was compared to etidronate followed by monofluorophosphate, calcium, and vitamin D (EFCaD)," said J. Ringe and colleagues, University of Cologne, Leverkusen, Germany.
Results showed that "bone mineral density (BMD) in lumbar spine, total hip, and femoral neck increased significantly more with EFCaD than with ECaD."
The researchers also reported that women's "pain-mobility score decreased significantly more with EFCaD than with ECaD (p=0.006). New vertebral fractures occurred in three patients under EFCaD (12%) and in nine under ECaD (35%), (p=0.048). Three patients under EFCaD (12%) and 15 under ECaD (58%) did not respond to therapy (p of difference=0.001). Mild or moderate adverse reactions were reported by 25 patients, with no significant difference between the two groups."
The researchers concluded, "The pilot study suggests that etidronate, sequentially followed by mono fluorophosphate, could be a safe, effective, and relatively inexpensive therapy in severe postmenopausal osteoporosis."
Ringe and coauthors published their study in Rheumatology International (Efficacy of etidronate and sequential monofluorophosphate in severe postmenopausal osteoporosis: a pilot study. Rheumatol Int, 2005;25(4):296-300).
Additional information can be obtained by contacting J. Ringe, University of Cologne, Klinikum Leverkusen, Med Klin 4, D-51375 Leverkusen, Germany.
Study 3: Intermittent bisphosphonate therapy reduces fracture risk in postmenopausal women, according to a recent paper in Clinical Therapeutics.
"The utility of bisphosphonates in the treatment of postmenopausal osteoporosis is compromised by the requirement of frequent oral administration or complex cyclic regimens. Recognition that simplified dosing regimens and reduced frequency of administration are important factors for improving adherence to therapy has led to the development of bisphosphonates with less frequent dosing regimens that aim to offer greater convenience," wrote Paul D. Miller, MD, of the Colorado Center for Bone Research.
Miller reviewed "the available data concerning the efficacy and tolerability of intermittent (less frequent than weekly) bisphosphonate dosing regimens for the treatment of postmenopausal osteoporosis, with particular focus on the potential implications for clinical management."
He included journal articles about intermittent or cyclic bisphosphonate dosing regimens that he found on MEDLINE.
"Because the currently available bisphosphonates differ in chemical structure, potency, and other physicochemical and biologic characteristics, comparable dose-free intervals may not be appropriate for all drugs," Miller noted.
"Several bisphosphonates have demonstrated efficacy in terms of an increase in bone mineral density (BMD) and a decrease in markers of bone turnover when administered intermittently. However, evidence of fracture benefit from a less frequent bisphosphonate dosing regimen was demonstrated recently. The nitrogen-containing bisphosphonate ibandronate was associated with a significant decrease in vertebral fracture risk when administered as an intermittent dosing regimen (p<0.001 vs. placebo). This study supports the concept that bisphosphonates such as ibandronate can be effectively administered less frequently than daily or weekly," Miller wrote.
He concluded, "Bisphosphonate therapy using intermittent schedules with between-dose intervals longer than 1 week is capable of reducing the risk of fracture, improving BMD, and suppressing biochemical markers of bone turnover. Planned and ongoing trials will determine the place of intermittent bisphosphonates in the treatment algorithm for postmenopausal osteoporosis."
Miller and coauthors published their study in Clinical Therapeutics (Optimizing the management of postmenopausal osteoporosis with bisphosphonates: The emerging role of intermittent therapy. Clin Ther, 2005;27(4):361-376).
For additional information, contact P.D. Miller, Colorado Center Bone Research, 3190 S Wadsworth Blvd., Lakewood, CO 80227, USA.
Keywords: Lakewood, Colorado, United States, Bisphosphonates, Intermittent Therapy, Osteoporosis, Postmenopausal Women, Women's Health.
This article was prepared by Biotech Week editors from staff and other reports. Copyright 2006, Biotech Week via NewsRx.com.
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