This study will evaluate whether the once weekly administration of the combination tablet
alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD)
more than the daily use of calcitriol.
Inclusion Criteria:
- Meets one of the following BMD criteria:
- Has BMD T-score ≤-2. 5 in at least one of the anatomic sites including lumbar spine,
total hip, and femoral neck, OR
- Has prior non-pathological fragility fracture (of spine, wrist, humerus or clavicle)
and BMD T-score ≤-1. 5 in at least one of the anatomic sites including lumbar spine,
total hip, and femoral neck sites
- Must have a baseline 25-hydroxyvitamin D ≥8 ng/mL (20 nmol/L)
- Is ambulatory
- Has been postmenopausal for at least one year
Exclusion Criteria:
- Has any contraindication to alendronate, including abnormalities of the esophagus
which delay esophageal emptying (such as stricture or achalasia), or inability to
stand/sit upright for at least 30 minutes, or hypersensitivity to alendronate and
vitamin D, or hypocalcemia
- Has any contraindications to calcitriol, and/or vitamin D, including hypercalcemia,
hypercalciuria, or active kidney stone disease
- Had a prior hip fracture
- Has received treatment with any of the following: anabolic steroid agent within the
past 12 months, systemic glucocorticoids for more than 2 weeks in the past 6 months,
oral bisphosphonates more than 3 months within the past 2 years, any lifetime use of
an intravenous administration of zoledronate, immunosuppressant other than
methotrexate, fluoride treatment at a dose greater than 1 mg/day for more than 2
weeks within the past 3 months, strontium containing products for more than 2 weeks
within the past 6 months, Parathyroid hormone for more than 2 weeks within the past 3
months, current use of chemotherapy, or heparin, growth hormone for more than 2 weeks
within the past 6 months, active hormonal vitamin D analogs (e. g., alphacalcidol,
calcitriol) in the past 30 days, or more than 5 days treatment of active hormonal
vitamin D analogs between 30 and 60 days prior to study entry., use of vitamin A
(excluding beta carotene) >10,000 IU daily, unless willing to discontinue this dose
during the study, current use of, lithium, or anti-convulsants, current use of
calcium supplement in amount excess of 1500 mg daily, unless willing to discontinue
this dose during the study, estrogen with or without progestin within the prior 6
months, Raloxifene or other selective estrogen receptor modulator ([SERM] including
tamoxifen), tibolone, or an aromatase inhibitor within the prior 6 months and/or
sub-cutaneous calcitonin or intra-nasal calcitonin within the prior 6 months
- Has a history of malignancy within previous 5 years
- Has one or more of the following concomitant conditions: uncontrolled upper
gastrointestinal disorders, myocardial infarction, unstable angina, stroke and
revascularization condition within 3 months, malabsorption syndrome, uncontrolled
primary or secondary hyperparathyroidism, uncontrolled thyroid disease, renal
insufficiency, uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine,
hematologic, neurological, psychiatric, or pulmonary diseases; unexplained laboratory
test abnormality or other conditions, uncontrolled hypertension, new onset diabetes
(within 3 months), poorly controlled hyperglycemia or abnormal fasting glucose,
hypoglycemia for any cause, history of, or evidence for metabolic bone disease other
than osteoporosis, abnormal serum calcium or phosphate, and/or active renal stone
disease when a calcium supplement is contraindicated
