14 global studies on osteoporosis medications FORTEO and EVISTA to be presented at ASBMR 2010

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Oct 18 2010Eli Lilly and Company

Eli Lilly and Company (NYSE: LLY) today announced that a total of 14 U.S. and global studies involving its osteoporosis medications, FORTEO® [teriparatide (rDNA origin) injection] and EVISTA® (raloxifene HCl tablets), will be presented at the American Society for Bone and Mineral Research (ASBMR) 2010 Annual Meeting from October 15-19 in Toronto, ON, Canada.

In partnership with TransPharma Medical Ltd., Lilly conducted a Phase II study and will present an oral poster session comparing efficacy, safety and teriparatide pharmacokinetics of teriparatide delivered transdermally and via SQ injection in a three-month, randomized, multicenter study in postmenopausal women with osteoporosis.

Of the nine additional studies involving teriparatide, eight investigated the effects of the treatment, with three also testing safety. Additional notes about teriparatide or raloxifene studies to be presented include:

One study used data from the teriparatide Fracture Prevention Trial to study the effect of body composition on bone.
Another study compared baseline characteristics, persistence to therapy and reasons for discontinuation between the Puerto Rican population and mainland United States population enrolled in a large observational study of teriparatide.
Two studies will be presented that investigated the Osteoporosis Patient Assessment Questionnaire (OPAQ) and were conducted using the Multiple Outcomes of Raloxifene Evaluation (MORE) trial database.
One study used data to develop a modified version of OPAQ, while another study examined the relationship between a comprehensive measure of risk of fracture, based on FRAX®, and health-related quality of life as measured by OPAQ.

The presentations are scheduled:

Comparison of Transdermal and subcutaneous teriparatide pharmacokinetics and pharmacodynamics of bone markers in postmenopausal women (Lead Author: Yael Kenan)
- Oct. 15, 5:45 p.m. to 7:00 p.m., [Poster No. FR0376]
- Oct. 16, 11:30 a.m. to 1:30 p.m., [Poster No. SA0376]
Effects of teriparatide and strontium ranelate on periosteal bone formation in the ilium of postmenopausal women with osteoporosis (Lead Author: R.R. Recker)
- Oct. 15, 5:45 to 7:00 p.m., [Poster No. FR0378]
- Oct. 16, 11:30 a.m. to 1:30 p.m., [Poster No. SA0378]
Teriparatide treatment in Japanese subjects with osteoporosis at high risk of fracture: effect of bone mineral density and bone turnover markers during 12-month, randomized, placebo-controlled, double-blind and 12-month open-label study periods (Lead Author: Toshio Matsumoto)

Oct. 15, 5:45 p.m. 7:00 p.m., [Poster No. FR0376]
Oct. 16, 11:30 a.m. to 1:30 p.m., [Poster No. SA0376]

Association of fracture risk and quality of life as measured by the Osteoporosis Patient Assessment Questionnaire (Lead Author: Steven Watts)

Oct. 16, 11:30 a.m. to 1:30 p.m., [Poster No. SA0358]

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) (Lead Author: J.B. Walsh)

Oct. 17, 11:00 a.m. to 1:00 p.m., [Poster No. SU0374]

The anabolic effect of teriparatide in postmenopausal women with osteoporosis measured using nuclear scintigraphy during and after therapy (Lead Author: Amelia EB Moore)

Oct. 17, 11:00 a.m. to 1:00 p.m., [Poster No. SU0379]

Teriparatide and risk of nonvertebral fractures in women with postmenopausal osteoporosis (Lead Author: John H. Krege)

Oct. 17, 11:00 a.m. to 1:00 p.m., [Poster No. SU0300]

Relationship between body composition and the skeleton (Lead Author: Xiaohai Wan)

Oct. 17, 11:00 a.m. to 1:00 p.m., [Poster No. SU0299]

Modification of the Osteoporosis Patient Assessment Questionnaire using item response theory methods (Lead Author: April N. Naegeli)

Oct. 17, 11:00 a.m. to 1:00 p.m., [Poster No. SU0410]

Characteristics of a Puerto Rican population initiating teriparatide therapy in the DANCE study (Lead Author: Valerie Ruff)

Oct. 18, 11:30 a.m. to 1:30 p.m., [Poster No. MO0370]

Attitudes toward compliance of patients participating in a randomized controlled trial (Lead Author: Deborah Gold)

Oct. 18, 11:30 a.m. to 1:30 p.m., [Poster No. MO0394]

Fractures in Commercial and Medicare Patients Treated with Raloxifene or Alendronate: A Retrospective Database Analysis (Lead Author: Shonda A. Foster)

Oct. 18, 11:30 a.m. to 1:30 p.m., [Poster No. MO0402]

Safety and Effectiveness Profile of Raloxifene in Long-term, Prospective, Observational Study (Final Report) (Lead Author: Etsuro Hamaya)

Oct. 18, 11:30 a.m. to 1:30 p.m., [Poster No. MO0409]

The effect of teriparatide on bone material properties is not different in postmenopausal women who were previously treatment-naïve or treated with alendronate (Lead Author: Birgit Buchinger)