Objective A retrospective study on the effectiveness and safety of alendronate (ALN) treatment in primary osteoporosis was carried out to explore the necessity of a drug holiday for long-term use of ALN. Methods Medical records of fifty-three primary osteoporosis patients receiving ALN treatment (70 mg, once a week, at least 3 years) from Jan 2010 to Dec 2016 were retrospectively analyzed. Simultaneously, all of them were given vitamin D and calcium as a basic treatment. The bone densitometry of lumbar spine L1-4, femoral neck and total hip and bone turnover markers such as P1NP and β-CTX level were measured at baseline and after 1, 2, 3, 4, 5 and 6 years of treatment, respectively. Results The average age of patients was (75.85±10.67) years, the average duration of medication was (4.83±1.54) years, and the longest duration reached 7 years. After 5 years of treatment, the BMD of lumbar spine L1-4 had the biggest rise compared with the baseline level (+12.579 %), and the difference was statistically significant (P<0.05). After 3 years of treatment, the BMD of femoral neck and total hip had the biggest rise compared with the baseline level (+3.516%) and (+6.676%), respectively, but both of them declined in the sixth year (-4.791%) and (-1.157%), respectively. As the time of ALN use increased, the decrease in the levels of bone turnover markers such as P1NP and β-CTX slowed down, or even had a trend of increase. The levels of P1NP at 0.25, 0.5, 1, 2 and 3 years were all significantly different from the baseline level (P<0.05). Four patients had fragility fractures during the treatment, and the incidence of brittle fracture was 7.54%. One person had delayed fracture healing. Conclusion The effectiveness of ALN in the treatment of POP was steadily increasing or stable for 3 to 5 years of continuous medication, but it decreased significantly after 3 to 5 years of treatment. The incidence of rare adverse reactions would increase after long term use of ALN. Therefore, it is necessary to carry out a drug holiday in patients with long-term use of alendronate. |