To observe the clinical efficacy and safety of salmon calcitonin nasal spray combined with calcium carbonate D₃ tablets in the treatment of disuse osteoporosis patients after ankle fracture surgery.

The disuse osteoporosis patients with postoperative ankle fractures were randomly divided into control group and treatment group using a random number table method. The control group was treated with calcium carbonate D₃ tablets 600 mg per time, twice daily, while the treatment group received salmon calcitonin nasal spray 200 U per time, once daily, in addition to the treatment in the control group. Both groups were treated for 6 months. The clinical efficacy, bone metabolic markers (osteocalcin, alkaline phosphatase), changes in bone mineral density (BMD) and postoperative pain level (VAS) were compared between the two groups, the safety evaluation was also conducted.

A total of 3 cases dropped out during the trial. Ultimately, the treatment group and the control group included 63 and 62 patients, respectively. After treatment, the overall effective rates for the treatment group and the control group were 93.65% (59 cases/63 cases) and 75.81% (47 cases/62 cases), respectively, with statistically significant difference (P<0.01). After 3 months of treatment, the BMD of the control and treatment groups were (0.87±0.09) and (0.93±0.08) g·cm^-2, respectively; serum osteocalcin levels were (20.10±3.20) and (22.80±3.50) ng·mL^-1, respectively; alkaline phosphatase levels were (74.50±12.30) and (80.10±13.20) U·L^-1, respectively; after 6 months of treatment, the BMD values for the control and treatment groups were (0.90±0.08) and (1.01±0.07) g·cm^-2, respectively; serum osteocalcin levels were (21.00±3.40) and (24.60±3.40) ng·mL^-1, respectively; alkaline phosphatase levels were (76.00±12.50) and (84.90±13.80) U·L^-1, respectively; statistically significant differences were observed for the above indicators between the experimental and control groups (P<0.05, P<0.001). After 3 months of treatment, the visual analog scale (VAS) scores of the control and treatment groups were (5.30±1.30) and (4.50±1.20) points, respectively; after 6 months of treatment, the VAS scores were (4.20±1.10) and (2.90±1.00) points, respectively; the differences between the treatment and control groups were statistically significant (all P<0.001). The main adverse drug reactions in the treatment group were nasal discomfort and nausea, while the control group were gastrointestinal discomfort. The total incidence of adverse drug reactions in the treatment and control groups were 7.94% (5 cases/63 cases) and 4.84% (3 cases/62 cases), respectively, without statistically significant difference between the two groups (P>0.05).

Salmon calcitonin nasal spray combined with calcium carbonate D₃ tablets can significantly increases BMD in disuse osteoporosis patients after ankle fracture surgery, reduce the risk of disuse osteoporosis, with good safety.