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 2010. 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.