Clinical Research Center:
The Clinical Research Center provides a comprehensive osteoporosis program including bone density testing, physician visits, patient education and research opportunities. Helen Hayes Hospital scientists in the Clinical Research Center (CRC) and Regional Bone Center are internationally recognized for excellence in clinical research of metabolic bone disease. Results from their research studies appeared in various leading journals, such as the New England Journal of Medicine, The American Journal of Medicine, The Journal of Bone and Mineral Research and Osteoporosis International.
The center has received funding from the National Institute of Health, the Department of Defense, and various foundations and pharmaceutical companies.
On the educational front, the CRC is in the second decade of funding from the New York State Department of Health to continue the New York State Osteoporosis Prevention and Education Program. Established in 1997, NYSOPEP makes it possible for all New Yorkers (the general public and medical professionals) to learn about the causes of osteoporosis, the value of prevention and early detection, and options for treatment. Helen Hayes Hospital was recently funded to act as the statewide Osteoporosis Resource Center and provide information that is accurate, current and evidence-based. Further details of this program can be found at www.nysopep.org or call 845-786-4772.
Regional Bone Center:
The Regional Bone Center (RBC) continues to pursue its mission of conducting a broad-based research program focused on the elucidation of cellular mechanisms underlying metabolic bone disease and the development of new treatments for bone disease.
RBC scientists are currently focusing on a comprehensive study of the factors that influence bone quality and strength. Osteoporosis is defined as a reduction in bone strength leading to an increased risk of fracture. Bone strength, in turn, is determined not only by bone mineral density, which we can measure clinically, but also by bone quality. While the factors that influence bone quality are not well understood at present, we know that there are many, including bone microarchitecture and geometry, mineralization, bone turnover, and microdamage. At the Regional Bone Center, state-of-the art technology is being applied to human iliac crest bone biopsies to assess such factors in variety of disease states, including osteoporosis, primary hyperparathyroidism, hypoparathyroidism, and Paget’s disease.
During the past several years a group of scientists from our Osteoporosis Research Center were part of a task force to evaluate the fractures that occur in the thigh bone of women being treated for osteoporosis.
Principal Investigator: Felicia Cosman
Investigators: David Dempster, Mathias Bostrom, Robert Lindsay, Jeri Nieves
Sponsor: NIAMS / NIH
Study: Early Effects of TPTD on the Proximal Femur
This study will provide critical information on how the bone building osteoporosis drug, teriparatide, affects the hip, and ultimately how this agent might help prevent hip fracture, the most serious of complications from osteoporosis.
Principal Investigator: Jeri Nieves
Study: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Dexlansoprazole 60 mg Delayed Release Capsules and Esomeprazole 40 mg Delayed Release Capsules on Bone Homeostasis in Healthy Postmenopausal Female. Bone density quality control only.
Principal Investigator: Jeri Nieves
Sponsor: New York State Department of Health
Study: The New York State Osteoporosis Prevention and Education Program (NYSOPEP)
NYSOPEP continues to educate New York residents, with Helen Hayes Hospital serving as the Statewide Osteoporosis Research Center. The goal of this program is to educate health professionals, other Department of Health staff and the public about osteoporosis and how to prevent this disease. Helen Hayes Hospital staff maintain our website www.nysopep.org and provide numerous educational materials and seminars (see below).
Principal Investigator Robert Lindsay
Investigators: David Dempster, Felicia Cosman, Jeri Nieves
Sponsor: NIAMS / NIH (IRB 08-01)
Study: This current proposal seeks to extend and expand on our NIH study to obtain long term data on TPTD effects on bone mass, structure and strength when TPTD is given daily or cyclically (3 monthly cycles for 4 years – equivalent to 2yrs of daily treatment, consistent with Forteo labeling). We also address the question of whether multiple cycles of TPTD treatment can produce repeated stimulation of bone formation and perhaps less stimulation of resorption than is seen with daily treatment. Since daily treatment results in tachyphylaxis during the second year of therapy, our hypothesis is that the same cumulative dose of TPTD given in short cycles will produce greater effects on bone mass, structure and strength than 2 years of daily treatment. Further, there may be differences in the effects of cyclic TPTD in the presence of alendronate, including a widening of the anabolic window.
Principal Investigator: Felicia Cosman, MD
Sponsor: Amgen (IRB# 10-05)
Study: The treatment of osteoporosis using a combination of Teriparatide (Forteo) and Denosumab (Prolia)
This is a three-year study to evaluate the effect of sequential therapy of teriparatide and Denosumab and to compare if the treatments when given as a daily sequential regimen or versus cyclic sequential regimen will increase bone density at the spine and other skeletal sites.
Principal Investigator: Jeri W. Nieves, PhD
Sponsor: NIH, University of Alabama at Birmingham (Dr. Ken Saag).
Study: Activating Patients to Reduce Osteoporosis (APROPOS)
The investigators will develop and pilot the intervention materials, and will conduct focus groups with patients that have similar characteristics as the population of interest (i.e. fracture history, not on osteoporosis treatment). Three initial focus groups were used to develop the intervention materials. The intervention materials will be sent to half the women and control materials to the other half. Questionnaires will determine if the intervention materials improve access to care for osteoporosis.