Status:
TERMINATED
Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation
Lead Sponsor:
Sanofi
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
Up to 65 years
Phase:
PHASE4
Brief Summary
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 anaboli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00790101
Start Date
June 1 2004
End Date
October 1 2004
Last Update
January 11 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807