Research ProjectsWe have served as the Coordinating Center for the following
studies:
ACCORD-BONE
A 6-year skeletal health ancillary study of 7,100 men and women with type 2 diabetes at 58 clinical centers
in the US and Canada. Sponsored by National Institute of Diabetes & Digestive & Kidney Diseases and the National Institute of Arthritis and
Musculoskeletal and Skin Diseases, NIDDK/NIAMS-NIH.
B-FIT
A three-year follow-up
study of cancer and fracture outcomes among the 25,000 postmenopausal women screened for
FIT. Sponsored by the National Cancer Institute, NIH.
CHIMES (Chinese Herbs In MEnopausal Symptoms)
A multi-center Phase II
randomized, double-blind, placebo-controlled clinical trial evaluating the
efficacy and safety of a Chinese herbal complex (MF101). 180 postmenopausal
women will be randomized at four clinical sites to one of two doses of MF101
or placebo, will take study medication for 12 weeks, and will be followed
for a total of 16 weeks.
Sponsored by BioNovo, Inc.
DAISy (Diagnostic Aspects of Incontinence Study)
A five-center, cross
sectional study comparing the accuracy of a simple incontinence
questionnaire (3IQ) to an extended evaluation (history, neurologic and
pelvic examination, postvoid residual and cough stress test) to distinguish
urge from stress incontinence. 301 women who reported at least 3 incontinent
episodes per week and were over 40 years old at baseline were enrolled in
this study.
Sponsored by Astellas Pharmaceuticals
FAST (Flashes and Sertraline Trial)
A double-blind, randomized,
placebo-controlled, clinical trial evaluating the efficacy of sertraline on
hot flashes. 100 healthy women with 14 or more hot flashes per week at
baseline will be randomized to sertraline or placebo and followed for 6
weeks.
The Fracture Intervention Trial (FIT)
This is an 11-center randomized
trial of alendronate to prevent fractures in 6,459 women age 55 years or older started in
1991 and concluded in 1997. Results from the first phase of this trial revealed that
alendronate is an effective agent to prevent osteoporotic fractures. Sponsored by Merck
and Company.
Fracture Intervention Trial Long Term Extension (FLEX)
An
extension of the FIT trial examining the effect of 10 years of Alendronate in women with
osteoporosis. Sponsored by Merck and Company.
Dynamics of Health, Aging and Body Composition (Health ABC)
A two-center,
10-year, longitudinal cohort study of 3,000 men and women over age 80, both Caucasian and
African American, to investigate risk factors for change in body composition, and the
effects of body composition on functional status and common diseases of aging. Sponsored
by the National Institute on Aging, NIH.
The Heart and Estrogen-progestin Replacement Study (HERS)
An 18-center,
four-year randomized controlled trial that tested the ability of estrogen plus progestin to prevent coronary
events in 2,763 postmenopausal women with documented coronary disease. Sponsored by
Wyeth-Ayerst Research.
HERS II
A three-year extension of the HERS trial that
includes 90% of the original randomized cohort. Sponsored by Wyeth-Ayerst Research.
HORIZON-PFT
UCSF serves as the scientific coordinating center and coordinates/performs fracture endpoints outcome
adjudication for this 3-year randomized, double-blind, placebo-controlled, international 230-center trial of 7,500 postmenopausal women
for the treatment of osteoporosis with once-yearly zoledronic acid. Sponsored by Novartis Pharmaceuticals.
HORIZON-PFT Extension
An additional 3-year follow-up to the HORIZON-PFT trial. The extension is a randomized,
double-blind, international trial of 2500 postmenopausal women for the treatment of osteoporosis with once-yearly zoledronic acid.
Sponsored by Novartis Pharmaceuticals.
The Isoflavone Clover Extract Trial (ICE)
A three-center, randomized controlled trial testing the effect of two
dietary supplements containing phytoestrogens derived from red clover on hot flashes and
quality of life for menopausal women. Sponsored by Novogen, Inc.
LookAhead
UCSF serves as the bone density quality assurance center for this large multicenter, long-term national study
(12+ years) to determine the health outcomes of weight loss on people with type 2 diabetes. Sponsored by National Institute of Diabetes &
Digestive & Kidney Diseases.
Medicine or Surgery (Ms)
A four-center randomized controlled trial comparing hysterectomy with medical
management for abnormal vaginal bleeding in premenopausal women, 50% of whom are African
American. Sponsored by the Agency for Health Care Policy and Research, USPHS.
Men’s Osteoporosis Study (Mr. OS)
An international multi-center study of
men’s health focusing on osteoporosis and prostate diseases. This longitudinal study is
sponsored by NIH and involves over 8,000 men in 9 centers in the US, Europe, and Asia.
Outcomes of Sleep Disorders in Older Men (MrOS Sleep Study)
An ancillary study to the MrOS Study that recruited
3,135 men to measure sleep habits and consequences of sleep disorders in older men. Measures obtained include actigraphy and polysomnography (psg).
Mitigation of Episodic Wasting in HIV Infection (WGHT)
A three-center, four-year,
randomized trial of the effects of recombinant human growth hormone and thalidomide on
weight and body composition in HIV-infected patients. Sponsored by the National Institute
of Allergy and Infectious Diseases, NIH.
The Multiple Outcomes of Raloxifene Trial (MORE)
UCSF coordinates
scientific activities for this multi-center international randomized trial of the effect
of raloxifene, a selective estrogen-receptor modulator, among 7705 postmenopausal women at
high risk of fracture. Sponsored by Eli Lilly and Co.
Multicenter Osteoarthritis (MOST) Study
This is a multi-center, longitudinal, prospective observational cohort study of knee osteoarthritis (OA).
MOST is funded by the National Institute on Aging.
Osteoarthritis in Chinese and Caucasians
A three-center, five-year international study
comparing the prevalence of, and risk factors for, osteoarthritis in mainland Chinese and U.S. Caucasians.
A cohort of 2500 elderly women and men has been assembled in Beijing. Sponsored by the National Institute
on Arthritis, Musculolskeletal and Skin Disease (NIAMS).
Osteoarthritis Initiative (OAI)
A public-private partnership between the National Institutes of
Health and industry that funds a multisite contract to create a resource to hasten discovery of biological markers
for osteoarthritis (OA). This four-year nationwide study will recruit 5,000 men and women aged 45 and above
at high risk for developing symptomatic knee osteoarthritis.
Parathyroid Hormone and Alendronate Study (PaTH)
A five-year, four-center randomized trial
designed to examine the effect of the PTH in combination with alendronate on bone density in women with osteoporosis.
Sponsored by the National Institute of Arthritis, Musculoskeletal and Skin Diseases
(NIAMS).
PaTH II
One-year observational follow-up of the 240 PaTH participants at four
clinical sites in the U.S. Sponsored by NPS Pharmaceuticals.
POWR
One-year randomized, double blind, placebo controlled trial of once-weekly
PTH for the treatment of osteopenia in 50 women at one clinical site in the U.S. Sponsored by National
Institute of Arthritis and Musculoskeletal and Skin Diseases, NIAMS-NIH.
POWR II
One-year open-label follow-up with once monthly ibandronate for the treatment of osteopenia in the 50 POWR
participants at one clinical site in the U.S. Sponsored by GlaxoSmithKline.
PRIDE
A two-center randomized, clinical trial evaluating weight reduction as a treatment for urinary incontinence in 330 overweight
and obese women with incontinence. Women are randomized to either a 6-month intensive behavioral weight reduction program or
usual care and followed for 18 months. One hundred women are participating in standardized urodynamic studies to evaluate the
mechanism by which weight loss improves incontinence. The trial is sponsored by the NIDDK.
The Study of Osteoporotic Fractures (SOF)
Now in its 16th year, the
first multi-center observational study of osteoporosis included 10,000 women 65 years or
older at four clinical center sites with over 95% complete follow-up for primary outcomes.
Over 100 publications have resulted from SOF since 1989. Sponsored by the National
Institute on Aging, National Institute of Arthritis and Musculoskeletal and Skin Diseases,
NIH.
TOP/OLES Nonvertan
SF CC serves as the fracture outcomes adjudication and analysis center for
the multicenter/international TOP trial and OLE follow-up study of PTH treatment in postmenopausal women with osteoporosis.
Sponsored by NPS Pharmaceuticals.
Ultra Low-dose Transdermal Estrogen Replacement Assessment (ULTRA)
A two-year, 9-site randomized controlled trial of the effect of ultra low-dose transdermal
estrogen on changes in bone density and other outcomes. Sponsored by Berlex Laboratories,
Inc. ULTRA Breast Density Study is an analysis of change in breast density in 276 post-menopausal women at 3 sites during a
two year, randomized, placebo-controlled trial of ultra low dose estradiol to maintain bone density. Mammograms are gathered
retrospectively and analysed at a central reading laboratory by computer-assisted contour analysis.
The Women’s Health Initiative (WHI)
UCSF serves as bone densitometry and fracture adjudication center and provides expertise
on osteoporosis aspects of the WHI. Sponsored by the Office of Women’s Research, NIH.
The Coordinating Center also provides data management system services for the following studies:
- ALS CONNECTION
- BHIVE
- BRACES
- COMPP
- DGE
- EPPEC
- KOZ
- MINO
- PART
- PEP
- PREVENT
- RESPERATE
- SCOPE
- STEP
- YOGA
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