New Study Data Analyses of PREOS Show Improved Bone Microarchitecture
NPS Pharmaceuticals today announced the results of two separate analyses of its Phase III TOP study data that corroborate previous findings that PREOS improves bone microarchitecture and reduces the incidence of first and subsequent vertebral fractures in high-risk postmenopausal osteoporotic women.
The data, which include a bone biopsy study using micro-computed tomography (CT), a three-dimensional imaging technology, and a vertebral (spinal) fracture study in women at high risk for osteoporotic fracture, were presented at the National Osteoporosis Foundation (NOF) Sixth International Symposium on Osteoporosis in Washington, D.C.
In the 18-month "Treatment of Osteoporosis with Parathyroid Hormone (TOP)" study, approximately 2,600 postmenopausal osteoporotic women were randomized to receive either a daily subcutaneous injection of 100 micrograms of PREOS (parathyroid hormone) or placebo, in addition to daily calcium and vitamin D supplements. At the conclusion of the study, iliac crest (pelvic) biopsies were obtained, and, prior to sectioning for microscopic examination (histomorphometry), they were scanned using micro-CT to assess the effect of PREOS on the microarchitecture of trabecular or "spongy" bone.