An observational study to assess back pain in patients with severe osteoporosis treated with teriparatide versus antiresorptives: An Indian subpopulation analysis.

BACKGROUND: One year, prospective, observational study in an Indian subpopulation to assess back pain in patients with severe osteoporosis treated with teriparatide or antiresorptives in a clinical setting. MATERIALS AND METHODS: One hundred and nineteen teriparatide-naοve Indian men and postmenopausal women (mean age 68.0 years) with previous osteoporotic vertebral fracture participated. Patients were assessed at baseline, 6-and 12-months to evaluate relative risk (RR) of new/worsening back pain using the Back Pain Questionnaire. The incidence of back pain and changes in back pain severity were assessed using the visual analog scale (VAS); Health outcomes were assessed using the euroquol-5 dimensions (EQ-5D) questionnaire. All tests were conducted with a two-sided alpha of 0.05. RESULTS: Of 562 overall patients, 57, 60, and 2 Indian patients received teriparatide, antiresorptive, or teriparatide and antiresorptive, respectively. Baseline disease characteristics were slightly worse for antiresorptive-treated patients, whereas teriparatide-treated patients were older with more comorbidities. At 6-months, the incidence of new/worsening back pain was 5.3% for teriparatide-treated patients versus 4.4% for antiresorptive-treated patients (RR: 1.00, 95% confidence interval: 0.68, 1.48); the incidence of severe back pain was 0% versus 12.5% (P = 0.017); in these treatment groups, respectively. Mean VAS change scores (mean ± standard deviation [SD]) were - 1.9 ± 1.73 versus - 1.4 ± 1.77, and mean EQ-5D change scores were 4.2 ± 27.20 versus 9.9 ± 26.23 at 6-months. At 6 months, more teriparatide-treated patients felt better (89% vs. 61%; P = 0.001) and were at least very satisfied with their treatment (30% vs. 9%; P = 0.011). CONCLUSION: Teriparatide-treated Indian patients had similar new/worsening back pain risk and minimal risk of severe back pain compared with antiresorptive-treated patients at 6-months.