Jintiange combined with alfacalcidol improves muscle strength and balance in primary osteoporosis: A randomized, double-blind, double-dummy, positive-controlled, multicenter clinical trial

OBJECTIVE: To investigate the effectiveness of a Chinese patent medicine, Jintiange capsules with the main component of artificial tiger bone powder, combined with alfacalcidol on muscle strength and balance of the lower extremities in patients with primary osteoporosis. DESIGN: A randomized, double-blind, double-dummy, positive-controlled, multicenter clinical trial. SUBJECTS AND METHODS: A total of 400 patients diagnosed with primary osteoporosis or osteopenia were recruited and randomized into the Jintiange or control groups. During the 52-week treatment, the participants in the Jintiange group were treated with Jintiange capsules (1.2 ​g each time, 3 times per day) and calcium carbonate simulant, while those in the control group were treated with calcium carbonate (element calcium 0.3 ​g, twice a day) and a Jintiange capsule simulant. Alfacalcidol (0.25 ​μg/d) was applied in both groups. The timed up and go test (TUG), chair rising test (CRT), and tandem gait test (TGT) were performed to evaluate balance, muscle strength and fall risk of the participants. RESULTS: There were 154 participants in the Jintiange group, and 157 participants in the control group were included in the per-protocol set. Comparing the data at week 52 from those at baseline, the TUG time decreased from 9.60 ​± ​2.25 ​s to 8.53 ​± ​2.06 ​s (p ​< ​0.001) in the Jintiange group and decreased from 9.50 ​± ​1.91 ​s to 9.11 ​± ​1.95 ​s (p ​< ​0.001) in the control group; the CRT time decreased from 11.49 ​± ​4.05 ​s to 8.57 ​± ​2.13 ​s (p ​< ​0.001) and 11.17 ​± ​3.21 ​s to 9.74 ​± ​1.98 ​s (p ​< ​0.001) in the Jintiange and control groups, respectively; the number of correct steps in the TGT increased significantly in both the control (7.40 ​± ​1.27 vs. 7.69 ​± ​0.87, p ​< ​0.01) and Jintiange groups (7.21 ​± ​1.58 vs. 7.60 ​± ​1.12, p ​< ​0.001). At the end of the study, the TUG and CRT results in the Jintiange group were superior to those in the control group (all p value ​< ​0.05), while no obvious difference was found in the TGT between the two groups. At week 52, the high fall risk proportions in the Jintiange group were significantly lower than those in the control group according to TUG (3.25% vs. 9.55%, p ​= ​0.023) and CRT (20.78% vs. 33.76%, p ​= ​0.01). CONCLUSION: Jintiange capsules combined with alfacalcidol can effectively improve muscle strength and the balance of the lower extremities and reduce fall risk in patients with primary osteoporosis/osteopenia. THE TRANSLATIONAL POTENTIAL OF THIS ARTICLE: Artificial tiger bone powder, a traditional Chinese patent medicine, can improve muscle strength and balance and reduce fall risks effectively among patients with primary osteoporosis. It might be a therapeutic option for osteoporosis individuals combined with sarcopenia to improve their muscle function.