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.

Background information
Trial ID: 
NCT00729651
Other unique IDs: 
2008_015
MK217A-263
Official title: 

A Phase IV (Phase V Program), Prospective, Randomized, Open-Label, Active-Controlled, Clinical Trial to Study the Efficacy and Safety of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis

Detailed description: 

 

Number to be enrolled: 
350 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Female
Eligibility criteria: 

Inclusion Criteria:

  • Patient has a spine or hip anatomy suitable for dual-energy x-ray absorptiometry
  • Patient has been postmenopausal defined as
    • 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
    • B) serum fsh greater than and equal to 30 iu/l in women who underwent hysterectomy
    • C) post bilateral oophorectomy
  • Patient has serum 25(oh)d greater than and equal to 9 ng/ml.
  • 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
  • Patient is suitable for treatment with oral bisphosphonate.
  • Patient meets one of the following:
    • 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,
    • 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),
    • 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
  • 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
  • Patient with pth higher than 72 ng/l at baseline will be excluded, however, a 10 % variance would be allowed

Exclusion criteria:

  • Patient has or has had a history of malignancy or active systemic diseases less than 5 years prior to signing informed consent
  • Patient with abnormalities of the esophagus that delay esophageal emptying

Study design: 
Treatment
Randomized
Active Control
Safety/Efficacy Study
Open Label
Parallel Assignment
Interventions: 
Alendronate sodium/Cholecalciferol (FOSAMAX Plus D)
Alendronate sodium (FOSAMAX)
Study arms: 
Experimental: Alendronate sodium/Cholecalciferol
Active Comparator: Alendronate sodium
Conditions treated: 
Osteoporosis Postmenopausal
Funding
Funding types: 
INDUSTRY
Sponsor: 
Merck
Dates
Date the data was first received: 
Tue, 2008-08-05
Trial start date: 
Sat, 2008-03-01
Trial completion date: 
Wed, 2009-04-01
Trial last updated: 
Thu, 2009-05-07