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Absolute risk for fracture and WHO guideline. Treatment of patients with secondary osteoporosis
Yamauchi M; World Health Organization. Clin Calcium. 2007 Jul;17(7):1106-13. Shimane University Faculty of Medicine, Internal medicine 1.
There has been accumulating evidence that various diseases and drugs cause increased risk of fracture. Although the treatment of primary diseases and discontinuation of drugs are the first and ideal option for the cure of secondary osteoporosis, medical intervention for osteoporosis is often necessary. The mechanisms, which induce bone fragility, are supposed to be different, depending on diseases and drugs. Guidelines for the evaluation and treatment of secondary osteoporosis have not been established except glucocorticoid-induced osteoporosis. In patients with osteoporosis caused by primary hyperparathyroidism, hyperthyroidism, diabetes mellitus as well as hormone deprivation therapy, bisphosphonate is effective in increasing bone mineral density but no data have been available about the fracture risk. Guidelines on the management and treatment of each secondary osteoporosis are desirable.
Proportion of osteoporotic post-menopausal women at increased risk for upper GI adverse events associated with bisphosphonate therapy.
Levine MA, Grootendorst P. Pharmacoepidemiol Drug Saf. 2000 Sep;9(5):367-70. Centre for Evaluation of Medicines, Father Sean O'Sullivan Research Centre.
Background: The bisphosphonate alendronate has been associated with higher rates of adverse oesophageal effects when used in the community setting compared to what was observed in the clinical trials. Patients with a history of gastroesophageal problems or who are concurrently using an NSAID therapy may be at increased risk for the gastroesophageal problems associated with alendronate use. This study assesses the proportion of post-menopausal women in the community with osteoporosis that are at increased risk for gastroesophageal adverse effects associated with alendronate.
Methods: The administrative database for the Quebec government drug benefit program was used to identify a cohort of 5400 post menopausal women aged 65 years or older who were using the bisphosphonate etidronate for the treatment of osteoporosis. Patients were evaluated for the presence of either risk factor, chronic GI drug therapy use (a marker for prior gastroesophageal problems) or chronic NSAID use.
Findings: 31% of women taking etidronate were also chronically using GI drug therapies and 50% were using NSAIDs; 18% of the women were using all three drugs.
Interpretation: Many osteoporosis patients in the community setting who are candidates for bisphosphonate therapy might be considered at increased risk for alendronate's gastroesophageal adverse effects. This may account for differences in pre-marketing and postmarketing event rates.
Bisphosphonate-associated osteonecrosis: a clinician's reference to patient management.
Grewal VS, Fayans EP.vgdds@hotmail.com Todays FDA. 2008 Aug;20(8):38-41, 43-6.
Bisphosphonates (BPs), as inhibitors of osteoclasts, are widely used in the management of metastatic bone disease and in the prevention of osteomalacia and osteoporosis. Recent cases of bone necrosis of the jaws have been associated with the use of bisphosphonate therapy. A case is presented of a patient with osteonecrosis of the maxilla with a history of long-term bisphosphonate therapy for metastatic breast cancer. The authors treated the patient and suggest appropriate patient management guidelines with reference to current knowledge. Although a definitive treatment for bisphosphonate-associated osteonecrosis has not yet been established, clinicians must be aware of the pharmacologic properties of several bisphosphonates currently available and their indications, susceptible risk factors in the development of osteonecrosis of the jaws, the clinical signs and symptoms, and recommendations for patient management, including prevention and early recognition.
BPs, potent inhibitors of osteoclast-mediated bone resorption, were first introduced more than 20 years ago. Since then, they have been used widely in the management of bone diseases, including hypercalcemia related to malignancy, myeloma-related bone disease, Paget's disease and osteoporosis. They have also been shown to inhibit tumor cell proliferation and inhibit angiogenesis. These additional features have made BPs useful in the treatment of metastatic disease, including breast and prostate cancer, resulting in a rise in the medical use of these drugs. However, recent reports suggest that BPs, particularly the nitrogen-containing BPs pamidronate (Aredia) and zoledronic acid (Zometa), both manufactured by Novartis of East Hanover, NJ, are capable of causing bisphosphonate-associated osteonecrosis of the jaw (BON). With 2.5 million patients treated with pamidronate and/or zoledronate worldwide, BON occurs in about one per 10,000 treated patients (Novartis, unpublished data, 2004). Currently, the total number of reported cases associated with alendronate (Fosamax, Merck and Co. Inc., White-house Station, NJ) the most commonly prescribed oral bisphosphonate, is approximately 170 worldwide (C. Arsver, oral communication, March 2006). This corresponds to a spontaneous BON incidence of approximately 0.7 cases per 100,000-years exposure. However, there is insufficient data to determine why the osteonecrosis reported seems to particularly affect the jaw, with a slightly higher rate in the mandible than the maxilla.
This report concerns the management of a patient with BON. Information provided includes: the pharmacologic properties of the several bisphosphonates currently available; the pathobiological mechanism; the clinical presentation of the oral lesions; and recommendations for the oral management of patients who have received BP therapy, with consideration of a preventative approach based on current knowledge.
Nonvertebral fracture risk reduction with nitrogen-containing bisphosphonates.
Hochberg MC. University of Maryland School of Medicine, 10 South Pine Street, MSTF 8-34, Baltimore, MD 21201, USA. mhochber@umaryland.edu Curr Osteoporos Rep. 2008
Osteoporosis is a systemic skeletal disorder characterized by low bone mass and microarchitectural deterioration of bone tissue resulting in compromised bone strength and an increased risk of fracture. There are two major fracture types: vertebral and nonvertebral. The latter include fractures involving the upper extremities, lower extremities (including hip), pelvis, and ribs.
A recent review comparing the efficacy and safety of drugs approved by the US Food and Drug Administration for treatment of osteoporosis demonstrated that although all of the agents have been shown to reduce the incidence of radiographic vertebral fractures, they do not all reduce the incidence of nonvertebral fractures. This article summarizes the most currently available data relative to nonvertebral and hip fracture risk reduction for the N-containing bisphosphonates alendronate, ibandronate, risedronate, and zoledronic acid, and presents results of an analysis of comparative efficacy of these compounds using the technique of adjusted indirect comparisons.
Calcium, vitamin D supplements with or without alendronate and supragingival calculus formation in osteoporotic women: a preliminary study.
Buduneli N, Saygan BH, Karaduman U, Saraç F, Karaduman M, Ayçelik N. Ege University, School of Dentistry, Department of Periodontology, 35100 Bornova, Izmir, Turkey. nurcan.buduneli@ege.edu.tr Expert Opin Pharmacother. 2008 Aug;9(12):2015-20.
OBJECTIVES: Long-term calcium intake is related to the formation of urinary stones. Structure and composition of kidney and gallstones are similar to dental calculus. Saliva is the source of calcium for supragingival dental calculus formation. The aim of this preliminary study was to evaluate the possible effects of long-term calcium and vitamin D supplementation with or without alendronate administration on salivary electrolyte concentrations and supragingival calculus formation in osteoporotic women.
METHODS: Thirty-one female patients with osteoporosis for at least 3 years participated in this study. Eighteen women were taking calcium plus vitamin D plus alendronate, while 13 women were taking only calcium plus vitamin D supplements. Eleven systemically healthy women volunteered for the control group. Whole saliva samples were collected from all women before initiation of any periodontal intervention. Plaque index, probing depth, clinical attachment level, bleeding on probing, and calculus index were recorded at six sites/tooth. Salivary concentrations of ionic calcium, potassium, magnesium and sodium were determined by atomic absorption spectrophotometer. Results were evaluated statistically by non-parametric tests.
RESULTS: No significant differences were found in clinical parameters or results of saliva analysis between the study groups (p > 0.05).
CONCLUSION: Within the limits of this preliminary study, it is suggested that long-term calcium and vitamin D supplementation with or without alendronate does not appear to have a significant effect on supragingival calculus formation or saliva total calcium, potassium, magnesium and sodium concentrations. Larger-scale studies investigating the possible effects of various treatment modalities of osteoporosis on supragingival calculus formation are required to better clarify this issue.
Postmarketing surveillance rates of uveitis and scleritis with bisphosphonates among a national veteran cohort.
VISN-8 Patient Safety Center of Inquiry, James A. Haley Hospital, Tampa, FL 33613, USA. Dustin.French@va.gov French DD, Margo CE. Retina. 2008 Jun;28(6):889-93.
PURPOSE: Uveitis and scleritis are the most serious ocular side effects of bisphosphonate therapy. The purpose of this study was to determine the 6-month rates of uveitis/scleritis following dispensing of bisphosphonates in a large veteran cohort.
METHODS: Two national databases (clinical and pharmacy) for fiscal year (FY) 2006 were linked to identify new diagnoses of uveitis/scleritis following the initial dispensing of bisphosphonate drugs. New diagnoses in FY 2006 were identified using International Classification of Diseases, Version 9, Clinical Modification (ICD-9-CM), in a cohort of veterans without a previous diagnosis of uveitis or scleritis using a look-back period to FY 2005. The new diagnoses were temporally aligned with initial dispensing of bisphosphonates and the rates of new cases were calculated for 1-month and 6-month time intervals.
RESULTS: There were 7.9 new cases of uveitis/scleritis per 10,000 individuals with a newly dispensed bisphosphonate that occurred within 180 days. The relative risk of uveitis/scleritis for 6 months was 1.23 (95% confidence interval: 0.85-1.79) compared to veterans not exposed to the medications. The rates of uveitis/scleritis did not differ significantly based on route of administration (oral or parenteral) or after age adjustment. Just over a third of the diagnoses were scleritis. Nearly 43% of patients with uveitis/scleritis after bisphosphonate use had a systemic diagnosis commonly associated with inflammation of the uveal tract or sclera.
CONCLUSIONS: The 30-day and 6-month rates of uveitis/scleritis following the dispensing of a bisphosphonate drug are low and do not differ significantly from rates recorded for veterans not dispensed these drugs.
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