Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation
Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation
This is a multi-center, randomized, double-blind, double-dummy study designed to compare the
 effects of risedronate, raloxifene, and placebo on BMD, bone turnover markers, and other
 markers of anabolic activity in postmenopausal women who previously received HRT.
Inclusion Criteria:

 -  Postmenopausal, ambulatory females, "postmenopausal" defined as the absence of menses
 for at least 12 continuous months)

 -  In general good health as determined by medical history, physical examination, and
 laboratory tests

 -  LS spine BMD T-score between -1.0 and -2.4, inclusive

 -  At least one analyzable BMD site at both the hip (left or right) and LS spine (at
 least 3 measurable lumbar spine vertebrae, without fracture or sufficient degenerative
 disease)

 -  Currently receiving no medications for the treatment or prevention of osteoporosis

 -  Had been on continuous HRT for at least 1 year prior to enrollment. The HRT must have
 ended within 18 months prior to the baseline visit, and the subject must have been off
 HRT medication for at least 3 months at the time of baseline visit

 -  Subjects rendered menopausal by surgical procedures between the ages of 55 and 65
 years

 Exclusion Criteria:

 -  A history of cancer within 10 years prior to entry into the study, except for
 relatively "benign" and cured skin cancers such as basal and squamous cell carcinoma

 -  A history of hyperparathyroidism, hyperthyroidism, osteomalacia, or other metabolic
 bone disease within one year prior to enrollment

 -  Any condition or disease that may interfere with the evaluation of at least 3 lumbar
 vertebrae (not necessarily contiguous), determined in a screening radiograph by a
 radiologist at the central facility (e.g., confluent aortic calcifications, severe
 osteoarthritis, spinal fusion, lumbar spine fractures)

 -  Evidence of clinically significant organic or psychiatric disease on history or
 physical examination, which in the opinion of the investigator would prevent the
 patient from completing the study

 -  Markedly abnormal pretreatment laboratory finds that, in the opinion of the
 investigator, would prevent the patient from completing the study

 -  A history of using any of the following medications prior to starting study:

 -  Any bisphosphonate therapy

 -  Selective estrogen receptor modulators (SERMs)

 -  Parathyroid hormone

 -  Fluorides

 -  Calcitonin

 -  Calcitriol (>1.5 mcg/week)

 -  Corticosteroids on a chronic basis for period equal to or greater then 3 months

 -  Received a depot injection of >10,000 IU Vitamin D in the past 12 months

 -  A history of recurrent nephrolithiasis or a history of one episode of nephrolithiasis
 within 1 year of study entry

 -  Serum creatinine >1.6 mg/dl

 -  Unable to sit or stand upright for 30 minutes after taking the morning dose of
 risedronate

 -  A history of deep vein thrombosis or other coagulation disorders

 -  Severe hepatic insufficiency

 -  A history of hypersensitivity to raloxifene, risedronate, or to drugs with similar
 chemical structures

 -  Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major
 systemic disease making implementation of the protocol or interpretation of the study
 results difficult

 -  Subjects found to have one or more vertebral fractures after completing thoracic and
 LS spine films

 -  Subjects who have experienced a low impact fracture related to osteopenia within two
 years of baseline visit

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial