Teriparatide in Elderly Women with Osteoporosis Based on Poster SU0374 Fracture Incidence, Quality of Life and Back Pain in Elderly Women (age >75 years) with Osteoporosis Treated with Teriparatide: 36 Month Results from the European Forsteo Observational Study (EFOS) James Walsh, Willem Lems, Dimitrios Karras, Bente Langdahl, Osten Ljunggren, Clare Barker, Astrid Fahrleitner-Pammer, Annabel Barrett, Gerald Rajzbaum, Franz Jakob, Fernando Marin Sunday, Oct 17, 2010 ASBMR 2010 Toronto, Ontario

Background Teriparatide is a recombinant form of parathyroid hormone (PTH). Given as a daily subcutaneous injection, the anabolic is approved for the treatment of osteoporosis and fracture prevention. Unlike anti-resportive agents which stop high bone turnover, teriparatide creates new bone tissue.

Method and Objective EFOS was a prospective observational study of postmenopausal women treated with teriparatide in normal European clinical practice. The objective of the subgroup study was to evaluate fracture outcomes, back pain and health-related quality of life (HR-QoL) 18 months after treatment had been discontinued in 589 women ≥75 who received teriparatide for up to 18 months. Data were available on 298 women ≥75 years of age who, following discontinuation of treatment, were treated with an anti-resorptive agent (2/3 on BP); over 80% also took calcium and vitamin D.

During 36 months of follow-up 87 patients (14.8%) sustained at least one incidence fracture. Of these: 68 women (78.2%) sustained a single fracture 19 (21.8%) sustained two or more fractures One-third were vertebral fractures

Fracture incidence in the Elderly Patient Subgroup (≥75 Years of Age) An 80% decrease in the odds of fracture was seen from the first 6-month period to months 30 to 36 (P<0.009)

Back Pain in the Elderly Patient Subgroup (≥75 yrs) More patients reported a decrease in frequency, severity and limitations of back pain than an increase (P<0.001).

Back pain VAS: Mean Change from Baseline Ng et al. ASBMR Abstract 1200.

Conclusions Mean EQ-5D VAS was 49.3 at baseline and improved significantly from baseline to all post-baseline visits. Changes from baseline in all relevant end points were still evident after discontinuation of teriparatide at 18 months, although the majority of patients received other osteoporosis therapies from month 18 onward. Findings should be interpreted in the context of a non-controlled observational study as well as the limited number of elderly subjects analyzed.