Osteoporosis Research
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  • 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.

    A National Institute of Health grant is funded to evaluate the mechanism of action of parathyroid hormone treatment in patients who remain on bisphosphonate therapy as compared to untreated individuals.  The NIH recently funded the center to follow these patients for a total of 4 years.

    On the educational front, the CRC is in the twelfth year of funding from the New York State Department of Health to continue to coordinate 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.

    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 year several of the 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.

    Current Programs:

    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:  Felicia Cosman
    Investigators: Jeri Nieves, Robert Lindsay
    Sponsor: Novartis Pharmaceuticals
    Study: The overall goal of this outcomes research proposal is to pilot a cost effective and practical strategy to improve the quality of care of those patients with osteoporosis related fractures who have the highest risk of future fractures and the greatest potential benefit from pharmacologic osteoporosis therapies.  The specific objectives of this outcomes research proposal are to: (1) Confirm the current status of osteoporosis diagnosis and treatment of adult fracture patients at a community rehabilitation hospital (Helen Hayes Hospital) affiliated with Columbia University using historical controls and patients currently being treated for rehabilitation of hip fracture at Helen Hayes Hospital (total n=60 patients).  (2) To test whether a NP/GP/educator intervention beginning in the inpatient setting and continuing in the outpatient department at the same hospital is an effective way to enhance compliance with NCQA measures and JCAHO after adulthood fracture, including nutritional and other lifestyle modifications and bone density testing (compared to rates in historical controls as determined in Objective 1). (3) To test whether a NP/educator intervention beginning in the inpatient setting and continuing in the outpatient department at the same hospital is an effective way to enhance compliance with NCQA and JCAHO measures including pharmacologic treatment of osteoporosis (compared to rates in historical controls as determined in Objective 1).

    Principal Investigator: Felicia Cosman
    Sponsor: NIH
    Study: An Evaluation of Quantitative Computed Tomography (pQCT) to measure bone after treatment with parathyroid hormone. In this study the SCANCO HRpQCT machine (XtremeCT, SCANCO Medical AG, Basserdorf, Switzerland) will be used to measure bone mineral density, size and structure of the arm and leg. The objective of this investigation is to determine cross sectional differences in bone size, volumetric differences and structure at the end of treatment with parathyroid hormone.

    Principal Investigator: Jeri W. Nieves
    Sponsor: University of Massachusetts
    Study: Global Longitudinal Registry of Osteoporosis in Women (GLOW). The goal of this research is to improve our understanding of the risk and prevention of osteoporosis-related fractures among female residents who are 55 years of age and older. The full study is multinational and will involve subjects from nine countries in 14 different locations, including Helen Hayes Hospital.

    Principal Investigator: Jeri Nieves
    Sponsor: Takeda
    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: Jeri Nieves
    Sponsor: None, collaboration with Hologic Inc
    Study: An Evaluation of 3 Dimensional Hip Measurements by DXA to measure structural properties of the femur after treatment with parathyroid hormone
    The objective of this investigation is to determine differences in bone size, shape and structure of the hip by DXA at the beginning and end of treatment with parathyroid hormone.  We will also determine how 3D hip DXA measurements compare with standard bone mineral density, with QCT assessments and with bone biopsy results.

    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.

    Managing Conflicts of Interest in Research Policy

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