Phase 4
N=53
Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women
Osteopenia · Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00504166 ↗Enrolled (actual)
53
Serious AEs
13.2%
Results posted
Aug 2011
Primary outcome: Primary: Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT — 2.1; -0.6; 0.9; 4.1 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- alendronate sodium (Drug); placebo comparator (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT |
2.1; -0.6; 0.9; 4.1 | — |
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 3 months ago for 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.
Data sourced from ClinicalTrials.gov (NCT00504166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.