Efficacy and Safety Study of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis
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- user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Patient has a spine or hip anatomy suitable for dual-energy x-ray absorptiometry</li>\n<li>Patient has been postmenopausal defined as\n<ul>\n<li>A) greater than and equal to 1 year beyond the lmp (last menstrual period) in women greater than and equal to 50 years of age with who did not received hysterectomy</li>\n<li>B) serum fsh greater than and equal to 30 iu/l in women who underwent hysterectomy</li>\n<li>C) post bilateral oophorectomy</li>\n</ul>\n</li>\n<li>Patient has serum 25(oh)d greater than and equal to 9 ng/ml.</li>\n<li>Patient with mean serum 25(oh)d is greater than and equal to 9 ng/ml, but not higher than 15 ng/ml (in 2 assay) is required to have serum pth and total alkaline phosphatase within the reference range</li>\n<li>Patient is suitable for treatment with oral bisphosphonate.</li>\n<li>Patient meets one of the following:\n<ul>\n<li>A) patient is a candidate for osteoporosis therapy with bisphosphonates, has bmd t-score less than and equal to 2.5 at at least one of testing locations including total hip, spine and femoral neck,</li>\n<li>B) patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or pth), has bmd t-score less than and equal to 2.0 and have 1 prior vertebral fracture (l1-l4),</li>\n<li>C) patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or pth), have greater than and equal to 2 prior vertebral fracture (l1-l4), or note: eligibility for this criterion is based on spine or femoral (neck or total) bmd</li>\n</ul>\n</li>\n<li>Patient understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to use sun cream and limit direct solar exposure in a hour/day for 16 weeks and participate by giving a written informed consent</li>\n<li>Patient with pth higher than 72 ng/l at baseline will be excluded, however, a 10 % variance would be allowed</li>\n</ul>\n</p><p> Exclusion criteria:\n<ul>\n<li>Patient has or has had a history of malignancy or active systemic diseases less than 5 years prior to signing informed consent</li>\n<li>Patient with abnormalities of the esophagus that delay esophageal emptying</li>\n</ul>\n</p>', created = 1283939662, expire = 1284026062, headers = '', serialized = 0 WHERE cid = '1:a96c419049b8910de0c6df1964d421f6' in /persistent/html/includes/cache.inc on line 109.
Trial phase:
Phase III
Recruitment status:
Completed To demonstrate the efficacy/safety of FOSAMAX PLUS D.
Conditions
Asthma
Brain and Central Nervous System Tumors
Breast Cancer
Cancer
Cardiovascular Diseases
Colorectal Cancer
Depression
Healthy
Heart Diseases
HIV Infections
Hypertension
Leukemia
Lung Cancer
Lymphoma
Myelodysplastic Syndromes
Obesity
Ovarian Cancer
Prostate Cancer
Schizophrenia
Unspecified Adult Solid Tumor, Protocol Specific
Clinical trial sponsors
AstraZeneca
Bristol-Myers Squibb
Department of Veterans Affairs
Eli Lilly and Company
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
GlaxoSmithKline
Hoffmann-La Roche
M.D. Anderson Cancer Center
Memorial Sloan-Kettering Cancer Center
Merck
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Drug Abuse (NIDA)
Novartis
Pfizer
Sanofi-Aventis
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Study design
Active Control
Cohort
Crossover Assignment
Dose Comparison
Double-Blind
Double Blind (Subject, Investigator)
Efficacy Study
Non-Randomized
Open Label
Other
Parallel Assignment
Placebo Control
Prevention
Prospective
Randomized
Safety/Efficacy Study
Safety Study
Single Group Assignment
Treatment
Uncontrolled
