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MK5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate - NCT00996801-20817(Clinical Trial 423470)



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City:  Bethesda
State:  
MD
Zip Code: 20817
Conditions: Osteoporosis
Purpose: This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be achieved by switching to MK5442 from an oral bisphosphonate in patients who have been receiving oral bisphosphonate therapy for at least 3 years.
Study summary:
Criteria: Inclusion Criteria: - Patient has been taking an oral bisphosphonate for osteoporosis for at least 3 years within the past 4 years, and the bisphosphonate must have been alendronate for the most recent 12 months, and is currently taking alendronate. - Patient has a BMD T-score that is <=-1.5 at one or more of the following 4 BMD sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is >= -4.0, AND a history of at least one fragility fracture, OR, an aBMD T-score that is <=-2.5 at one or more of the following 4 BMD sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is >= -4.0 - Patient has been postmenopausal for at least 5 years Exclusion Criteria: - Patient is unable to have DXA performed due to obesity - Patient has received IV bisphosphonates, fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks, strontium, growth hormone, a cathepsin K inhibitor, or a RANK-L inhibitor at any time in the past - Patient has received oral bisphosphonates other than alendronate in the last 12 months, PTH in the last 24 months, cyclosporin for more than 2 weeks in the last 6 months, heparin in the last 2 weeks, or anabolic steroids or glucocorticoids for more than 2 weeks in the past 6 months - Patient has used estrogen with or without progestin or a selective estrogen receptor modulator (SERM) in the last 6 months or calcitonin in the last 30 days - Patient has used pioglitazone hydrochloride or rosiglitazone hydrochloride in the last 6 months - Patient is taking more than 10,000 IU vitamin A daily or more than 5,000 IU vitamin D daily - Patient has had a total thyroidectomy - Patient has any history of Paget's disease - Patient is HIV positive - Patient has a history of cancer in the last 5 years, except certain skin or cervical cancers - Patient has a history of major upper GI mucosal erosive disease - Patient is unable to adhere to dosing instructions for alendronate in regard to fasting and positioning - Patient is not ambulatory - Patient has new-onset diabetes or poorly controlled hyperglycemia
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Data Source: ClinicalTrials.gov
Date Processed: April 13, 2010
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