Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation
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ClinicalTrials.gov Identifier: NCT00790101 |
Recruitment Status :
Terminated
First Posted : November 13, 2008
Last Update Posted : January 11, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis, Postmenopausal | Drug: Risedronate Drug: Raloxifene Other: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | An 18-Month, Multicenter, Parallel-Group Study to Determine The Relative Efficacy of Risedronate Versus Raloxifene in Subjects Who Have Discontinued Hormone Replacement Therapy (HRT) for Early Intervention in Osteoporosis |
Study Start Date : | June 2004 |
Actual Study Completion Date : | October 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Risedronate 35mg once a week
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Drug: Risedronate |
Active Comparator: 2
Raloxifene 60mg daily
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Drug: Raloxifene |
Placebo Comparator: 3 |
Other: Placebo |
- Compare the effects of risedronate and raloxifene on lumbar spine (LS) bone mineral density (BMD) in osteopenic women previously treated with HRT, who discontinued HRT at least 3 months prior to the study but no greater than 18 mos
- Compare the effects of risedronate, raloxifene, and placebo on BMD of the hip

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Ages Eligible for Study: | up to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790101
United States, New Jersey | |
Sanofi-Aventis | |
Bridgewater, New Jersey, United States, 08807 |
Study Director: | Tara Semanchik | Sanofi |
Responsible Party: | Medical Affairs Study Director, Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00790101 |
Other Study ID Numbers: |
HMR4003B_4033 |
First Posted: | November 13, 2008 Key Record Dates |
Last Update Posted: | January 11, 2011 |
Last Verified: | January 2011 |
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Risedronic Acid Raloxifene Hydrochloride Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Selective Estrogen Receptor Modulators Estrogen Receptor Modulators |