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Long-term follow-up of patients on drug holiday from bisphosphonates: real-world setting Journal Article
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| Authors: | Chiha, M; Myers, L. E.; Ball, C. A.; Sinacore, J. M.; Camacho, P. M. |
| Article Title: | Long-term follow-up of patients on drug holiday from bisphosphonates: real-world setting |
| Abstract: | OBJECTIVE: Atypical femoral fractures and osteoporosis of the jaw have been associated with prolonged bisphosphonate therapy for postmenopausal osteoporosis. American Association of Clinical Endocrinologists guidelines suggest a drug holiday after 4 to 5 years of bisphosphonate treatment for moderate-risk patients and 10 years for high-risk patients, but there are minimal data on safe holiday durations. A recent U. S. Food and Drug Administration perspective suggests a treatment duration of 3 to 5 years. Our aim was to describe a group of patients on drug holiday and identify fracture risk. METHODS: A retrospective chart review was conducted of 209 patients who started a bisphosphonate drug holiday between 2005 and 2010. Collected data included bone mineral density (BMD), markers of bone turnover, vitamin D status, and clinical and radiographic reports of fractures. RESULTS: Eleven of 209 patients (5.2%) developed a fracture. Their mean age was 69.36 years (+/-15.58), and the mean lumbar spine and femoral neck T-scores were -2.225 (+/-1.779) and -2.137 (+/-0.950), respectively. All patients had a significant increase in bone-specific alkaline phosphatase at 6 months, which was more pronounced in the fracture group (3.0 +/- 0.6083 mug/L vs. 1.16 +/- 1.9267 mug/L). Over 4 years, there was no significant change in mean lumbar spine BMD for the entire cohort, but there was a statistically significant decline in the femoral neck BMD at year 2 (-0.0084 +/- 0.03 gm/cm2). CONCLUSION: The current practice of initiating BP holidays needs further evaluation, particularly in the real-world setting. Elderly patients and those with very low BMD warrant close follow-up during a drug holiday. A fracture, early significant rise in bone turnover markers, and/or a decline in BMD should warrant resumption of osteoporosis therapy. |
| Journal Title: | Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists |
| Volume: | 19 |
| Issue: | 6 |
| ISSN: | 1934-2403; 1530-891X |
| Publisher: | Unknown |
| Journal Place: | United States |
| Date Published: | 2013 |
| Start Page: | 989 |
| End Page: | 994 |
| Language: | eng |
| DOI/URL: | |
| Notes: | JID: 9607439; 0 (Bone Density Conservation Agents); 0 (Diphosphonates); 0 (Vitamins); 1406-16-2 (Vitamin D); EC 3.1.3.1 (Alkaline Phosphatase); ppublish |
