Principal Investigators
Robert Lindsay/Felicia Cosman: Sponsor: Roche
Laboratories Study: An open label, multi-center study to determine
level of adherence to monthly oral or every three month intravenous
ibandronate treatment in postmenopausal women with osteoporosis
or osteopenia, who are GI intolerant of daily and/or weekly
alendronate or risedronate (ML 18058)
Principal Investigator: Felicia
Cosman: Sponsor: Eli Lilly
Study: Effects of Subcutaneous Teriparatide on Serum Calcium
in Postmenopausal Women with Osteoporosis Previously Treated
with Raloxifene or Alendronate (B3D-MC-GHCM)
Principal Investigator: Felicia
Cosman: Sponsor: Novartis
Study: Randomized, multicenter, double-blind, double-dummy,
parallel group study to determine the efficacy and safety
of intravenous zoledronic acid 5 mg annually compared to oral
alendronate 70 mg weekly for the treatment of osteoporosis
in men (CZOL446M2308)
Principal Investigators Robert
Lindsay/Felicia Cosman: Sponsor: Roche Laboratories
Study: An open label, multi-center study to determine level
of adherence to monthly oral or every three month intravenous
ibandronate treatment in postmenopausal women with osteoporosis
or osteopenia, who are GI intolerant of daily and/or weekly
alendronate or risedronate (ML 18058).
Principal Investigator Robert
Lindsay Sponsor: Novartis
Study: A multicenter, randomized, double blind, double-dummy
study to determine the rapidity of onset of zoledronic acid
compared to alendronate in post-menopausal women with moderate/severe
osteopenia or osteoporosis. Novartis Study No. CZOL446H 2315
Principal Investigator: Felicia
Cosman: Sponsor: Novartis
Study: Randomized, multicenter, double-blind, double-dummy,
parallel group study to determine the efficacy and safety
of intravenous zoledronic acid 5 mg annually compared to oral
alendronate 70 mg weekly for the treatment of osteoporosis
in men (CZOL446M2308)
Ongoing Clinical Research Studies:
Felicia Cosman, M.D continues as the Principal
Investigator on a multicenter three-year study sponsored by
Novartis to evaluate whether an intravenous administration
of a bisphosphonate given once a year will reduce the rate
of fractures compared to patients given a placebo.
Jeri Nieves, Ph.D. completed as Principal Investigator
the study of the Evaluation of Continuous Summary Physical
Performance Scores in the elderly. Helen Hayes Hospital recruited
30 patients for this study and served as the data management
center for this multicenter clinical trial sponsored by Bristol-Myers
Squibb. The first manuscript was recently published and a
follow-up manuscript is being prepared.
Dr. Cosman is continuing the second year of
a study to determine the efficacy of Fosamax vs. Actonel on
bone mass and body composition, sponsored by Merck, Inc.
The Clinical Research Center, in conjunction
with the Regional Bone Center, continues their efforts to
accomplish the research goals of the Specialized Center of
Osteoporosis Research grant. The clinical project examining
parathyroid hormone in addition to ongoing alendronate therapy
was completed during 2004 and the results will be published
shortly.
Felicia Cosman, M.D. continues to serve as
the Principal Investigator on a trial of patients who are
currently on raloxifene, who will be randomized to raloxifene
alone or parathyroid hormone and raloxifene to see whether
bone turnover and bone density are further improved within
the combined treatment. An observational extension to this
study includes a one-year challenge or re-challenge with PTH
for patients taking raloxifene who still have osteoporosis.
The purpose of this study is to determine whether forteo leads
to similar increases in markers of bone formation and resorption
in patients who have recently taken raloxifene.
Dr. Nieves completed recruitment for the grant
Oral Contraceptives and Bone Health in Female Runners. Dr.
Kelsey at Stanford University is the Principal Investigator
of this Dept. of Army funded study. Women long distance runners
have been recruited into a randomized trial of oral contraceptives
to see whether bone mass can be stabilized in this population.
This study will be completed in 2005.
Dr. Nieves is analyzing the results of her
study of nutritional supplementation in black postmenopausal
women, a study funded by the National Institutes of Aging.
Several papers are currently being completed and submitted
for publication.
An evaluation of Quantitative Computed Tomography
(QCT) to Measure Bone Mineral Density: after Parathyroid Hormone
Therapy. PI: Dr. Cosman This study will determine the amount
of bone in the spine and hip using an x-ray procedure called
Quantitative Computed Tomography (QCT) following parathyroid
hormone treatment. This is done using the QCT of Dr. Noah
Weg.
Primary hyperthyroidism PIs: Dr. Nieves, Cosman
and Dempster, in conjunction with Dr. Belizikien at Columbia
University, HHH investigators will assist in the design and
data analysis of fracture occurrence in patients with primary
hyperparathyroidism and Dr. Dempster will continue to analyze
and interpret bone biopsy data from this study.
Dr. Lindsay continues his work on the study
“Open label study to determine how prior therapy with
alendronate or risedronate in postmenopausal women with osteoporosis
influences the clinical effectiveness of teriparatide”.
The purpose of this study is to determine whether teriparatide
work as well in patients who have recently taken alendronate
as compared to patients who recently took risedronate.
Dr. Lindsay continues as PI for the Wyeth research
protocol # 3115A 303 US: A double blind, randomized, placebo
and active controlled safety and efficacy study of Bazedoxifene/conjugated
estrogens combinations in postmenopausal women. The Bone Quality
Control Center which has been contracted to do the bone density
quality control for a multicenter clinical trial of over 3000
women to evaluate a tissue selective estrogen and estrogen
combination in the prevention of osteoporosis.
Apomine as a potential new treatment for osteoporosis:
PI: Dr. Lindsay and a center in Omaha, Nebraska will continue
the investigation of a potential new treatment for osteoporosis
(apomine) with Ilex Pharmaceuticals.
Dr. Nieves serves as the Principal Investigator
of The New York State Osteoporosis Prevention and Education
Program (NYSOPEP), an educational program that has been refunded
from 2003-2008. Helen Hayes Hospital serves as both a regional
center and as the coordinating center for this statewide effort.
The goal of this program is to educate health professionals
and the public about osteoporosis and how to prevent this
disease. NYSOPEP has its own web site, www.nysopep.org. NYSOPEP
staff travel throughout the state, giving numerous talks,
and oversee three support groups (Helen Hayes Hospital, Fountainview,
and Orange County). In addition, The Bone Health Seminar,
a comprehensive education program is ongoing for Helen Hayes
Hospital patients and is also open to the public.
|
