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Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation | Clinical Trials | Clareo Health

TERMINATEDPHASE4

Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation

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

NCT00790101•Sanofi

View on ClinicalTrials.gov

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 anabolic activity in postmenopausal women who previously received HRT.

Eligibility

Age

0 - 65 years

Sex

FEMALE

Healthy Volunteers

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
+14 more criteria

Locations (1)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Key Dates

Start Date

June 1, 2004

Completion Date

October 1, 2004

Last Updated

January 11, 2011

Enrollment

ACTUAL participants

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronate

DRUG

Raloxifene

DRUG

Placebo

OTHER

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Osteoporosis, Postmenopausal

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RECRUITINGNA

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WITHDRAWNPHASE4

Effect of Mechanical Loading With PTH on Cortical Bone

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Efficacy and Safety of MW031 in PMO Subjects