Minimum age: 50 Years.
Maximum age: N/A.
- 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
- B) serum fsh greater than and equal to 30 iu/l in women who underwent
- 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
- 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)
- 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
- Patient with pth higher than 72 ng/l at baseline will be excluded, however, a 10 %
variance would be allowed
- 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