Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women
Condition: Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Intervention: alendronate sodium; placebo comparator
Intervention description: alendronate sodium 70 mg tablet once week for 24 months; placebo to match alendronate sodium one tablet once a week for 24 months
Intervention MeSH terms: Alendronate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: Female
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the changes in bone structure as determined by
      magnetic resonance imaging measurements among early postmenopausal women after 24 months of
      treatment with alendronate, 70 mg once a week as compared to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  early postmenopausal women

          -  45-65 years old

          -  T-score range -1.1 to -2.5 either at the lumbar spine or any hip site exclusive of
             Ward's triangle

          -  at least 3 vertebrae rom L1-L4 must be evaluable

        Exclusion Criteria:

          -  Those at high risk for osteoporotic fracture within the next 24 months, such that
             randomization to a placebo would be unacceptable (e.g., prior history of hip fracture,
             recent symptomatic clinical vertebral fracture, or very low BMD [i.e., BMD > 2.5 SD
             below young normal bone mass at any site exclusive of Ward's Triangle])

          -  Current excessive tobacco use

          -  Abnormality of the esophagus which delays esophageal emptying, such as stricture or
             achalasia

          -  Gastroesophageal reflux disease sufficient to require regular medication

          -  Inability to stand or sit upright for at least 30 minutes once a week

          -  Current use of any illicit drugs or has a history of drug or alcohol abuse within the
             past 5 years

          -  Current alcohol use > 3 drinks/day

          -  Any of the following: hypocalcemia; severe malabsorption syndrome; moderate or severe
             hypertension which is uncontrolled; new onset angina or myocardial infarction within
             six months of entry into the study; evidence for impaired renal function defined as
             creatinine clearance <35 ml/min or serum creatinine greater than 1.6 mg/dL; organ
             transplantation; or other significant end organ diseases (genitourinary,
             cardiovascular, endocrine, hepatic, psychiatric, renal, hematologic, or pulmonary)
             which, in the opinion of the investigator, may pose an added risk to the patient or
             impair the patient's ability to complete the trial

          -  History of or evidence for metabolic bone disease (other than postmenopausal bone
             loss) including but not limited to vitamin D deficiency (25-hydroxy-vitamin D level
             <10 ng/ml), hypoparathyroidism, recent hyperthyroidism (suppressed TSH within the six
             months prior to entry into the study), Paget's disease of bone, Cushing's disease,
             osteomalacia and renal osteodystrophy

          -  History of cancer. However, patients with the following cancers will be considered
             eligible for the study: 1) superficial basal or squamous cell carcinoma of the skin
             which has been completely resected; 2) other malignancies completely treated without
             recurrence or treatment in the last 5 years, with the following exceptions: patients
             with a history of breast cancer (including histologic diagnosis of lobular carcinoma
             in situ), endometrial carcinoma, or other known or suspected estrogen-sensitive
             neoplasia are excluded regardless of time since treatment or disease status

          -  Any treatment with a bisphosphonate or parathyroid hormone; within the last 6 months:
             estrogen, estrogen analogues (e.g. raloxifene, tamoxifen) tibolone or anabolic
             steroids; Estrogen taken > 3 months ago for < 1 week is acceptable; Topical (vaginal)
             estrogen cream (< 2 g) used up to 2 times weekly is acceptable; Thyroid hormone,
             unless on a stable dose for at least six weeks before randomization with serum TSH
             within normal range; Fluoride treatment at a dose greater than 1 mg/day for more than
             1 month at any time; given for a shorter time than one month it must have been greater
             than 1 year before randomization; Glucocorticoid treatment for more than one month
             with > 7.5 mg of oral prednisone (or the equivalent) per day within six months prior
             to randomization; patients who have received therapeutic glucocorticoids in the past
             must be considered highly unlikely to require retreatment with any dose of oral
             glucocorticoids for more than one month during the course of the study; Treatment with
             an immunosuppressant (e.g., cyclosporine, azathioprine) within the previous year.

          -  Current or expected treatment during the course of the study of any medication which
             might alter bone or calcium metabolism, including vitamin A in excess of 10,000 IU per
             day, or vitamin D in excess of 5,000IU per day, calcitonin, phenytoin, heparin, or
             lithium.