Effects of tibolone combined with zoledronic acid on bone density, bone metabolism, and pain in postmenopausal patients with osteoporosis

Abstract

Objective: To explore the efficacy and safety of tibolone combined with zoledronic acid in the treatment of postmenopausal osteoporosis (PMO).

Methods: We conducted a retrospective analysis of 121 PMO patients from March 2019 to July 2021. Patients were divided into two groups based on treatment regimen: an observation group (n=62) receiving zoledronic acid combined with tibolone and a control group (n=59) receiving tibolone monotherapy. We evaluated and compared therapeutic efficacy, bone mineral density, bone metabolism markers (osteocalcin, serum C-terminal telopeptide of type I collagen, and bone alkaline phosphatase), pain, knee joint function, incidence of fragility fractures, and adverse reactions. Logistic regression analysis was used to evaluate risk factors affecting treatment efficacy.

Results: The observation group showed a significantly higher therapeutic effect (96.77%) compared to the control group (83.05%), and a lower incidence of fragility fractures (P=0.012). Before treatment, there were no significant differences in bone mineral density, bone metabolism markers, pain status, or knee function between the two groups (all P>0.05). However, after treatment, evaluations showed marked improvements in these parameters in both groups, with more significant enhancements observed in the observation group (all P<0.001). The incidence of adverse reactions did not significantly differ between the groups (20.97% vs 13.56%, P=0.282). Logistic regression analysis identified the use of tibolone combined with zoledronic acid as a protective factor for effective treatment.

Conclusions: Tibolone combined with zoledronic acid significantly increases bone mineral density, improves bone metabolism, and reduces pain in PMO patients, with a safety profile comparable to that of monotherapy. This regimen should be considered for clinical use in treating PMO.

Keywords: Tibolone; bone metabolism; bone mineral density; postmenopausal osteoporosis; zoledronic acid.

Figure 1

Comparison of bone mineral density before and after treatment. A: Comparison of lumbar vertebrae bone mineral density before and after treatment between the two groups of patients; B: Comparison of hip bone mineral density before and after treatment between the two groups of patients. Note: * indicates P<0.05.

Figure 2

Comparison of bone metabolic function indexes before and after treatment. A: Comparison of osteocalcin before and after treatment; B: Comparison of CTX before and after treatment; C: Comparison of BALP before and after treatment. Note: * indicates P<0.05. CTX, C-terminal telopeptide of type I collagen; BALP, bone alkaline phosphatase.