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Bisphosphonate drug holidays warrant close follow-up, evaluation
The initiation of bisphosphonate holidays requires further evaluation. In particular, researchers recommend that a close follow-up is warranted in patients who are considered to be elderly and have low bone mineral density.
Patients who show early significant rise in bone turnover markers, and/or a decline in BMD should resume their prior osteoporosis therapies, according to data published in Endocrine Practice.
“This study provides some guidance about what to do during drug holidays and how long they should last,” Pauline Camacho, MD, director of the Loyola University Osteoporosis and Metabolic Bone Disease Center, said in a press release. “The results highlight groups who are at risk for fractures during drug holidays and recommendations on when to resume treatment.”
Camacho and colleagues conducted the retrospective chart review of 209 patients who began a bisphosphonate drug holiday between 2005 and 2010. More than half (67%) of the patients were on alendronate (Fosamax, Merck), 27.3% were on risedronate (Actonel, Warner Chilcott), and 5.7% were on ibandronate (Boniva, Genentech) at baseline.
Eleven of 209 patients (5.2%; mean age, 69.36 years) developed a fracture within 2 years, according to researchers. This group had a mean lumbar spine of –2.225 and femoral neck T-score of –2.137, according to data.
“These individuals did not suffer any fractures while on therapy,” the researchers wrote.
All of the patients enrolled demonstrated an increase in bone-specific alkaline phosphatase at 6 months. This was especially true for the fracture group (3 mcg/L vs. 1.16 mcg/L).
At 4 years, no significant changes in the mean lumbar spine BMD were observed for the entire cohort (mean change, –0.002833 g/cm2; 95% CI, 0.085448–0.34884), according to data. However, data indicate there was a significant decrease in femoral neck BMD at 2 years (mean change, –0.00841 gm/cm2; 95% CI, –0.016755 to –0.000065).
The type of bisphosphonate therapy used prior to a drug holiday did not have a significant impact on measurements of BMD or bone-specific alkaline phosphatase changes, researchers wrote.The 2010 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.
“These findings will help us continue to refine the current practice of drug holidays to better manage patients with osteoporosis,” Camacho said in the release.
Disclosure: Camacho reports research grants from Amgen, Eli Lilly, and Proctor and Gamble.
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