A Real-Life Study in Sequential Therapy for Severe Menopausal Osteoporosis

Background: Teriparatide (TPT) acts against severe primary (postmenopausal) osteoporosis (MOP), and it requires continuation with another anti-resorptive drug to conserve or enhance the effects on fracture risk reduction. Objective: To analyse the sequential pharmacotherapy in MOP who were treated upon a 24-month daily 20 µg TPT protocol (24-mo-TPT) followed by another 12 months of anti-resorptive drugs (12-mo-AR) amid real-life settings. Hypotheses: 1. TPT candidates had a more severe fracture risk profile versus those who did not fulfil the TPT criteria according to the national protocol of TPT initiation; 2. Patients treated with TPT improved their DXA profile after 24 mo; 3. After 1 year of therapy since the last TPT injection, the improved bone profile and fracture risk at the end of the TPT protocol were conserved; 4. The mineral metabolism assays and fracture risk status were similar at TPT initiation between those who finished the 24 mo protocol and those who prematurely stopped it. Methods: This was a longitudinal, retrospective, multicentre study in MOP. The entire cohort (group A) included the TPT group (B) versus the non-TPT group (non-B). Group B included subjects who finished 24-mo-TPT (group P) and early droppers (ED), and then both continued 12-mo-AR. Results: Group B (40.5%) from cohort A (N = 79) vs. non-B had lower T-scores, increased age and years since menopause. A similar profile of demographic features, BTM, and prevalent fractures (73%, respectively, 57%) was found in group P (72%) vs. ED (21.8%). Group P: osteocalcin was statistically significantly higher at 12 mo (+308.39%), respectively, at 24 mo (+171.65%) vs. baseline (p < 0.001 for each), while at 12-mo-AR became similar to baseline (p = 0.615). The cumulative probability of transient hypercalcemia-free follow-up of protocol had the highest value of 0.97 at 6 mo. An incidental fracture (1/32) was confirmed under 24-mo-TPT. BMD had a mean percent increase at the lumbar spine of +8.21% (p < 0.001), of +12.22% (p < 0.001), respectively, of +11.39% (p < 0.001). The pharmacologic sequence for 12-mo-AR included bisphosphonates (24.24% were oral BP) or denosumab (13%). BTM showed a suppression at 12-mo-AR (p < 0.05), while all BMD/T-scores were stationary. No incidental fracture was registered during 12-mo-AR. Conclusions: All research hypotheses were confirmed. This study in high-risk MOP highlighted an effective sequential pharmacotherapy in reducing the fracture risk as pinpointed by BMD/T-score measurements and analysing the incidental fractures profile.