Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation

This study has been terminated.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00790101
First received: November 11, 2008
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Osteoporosis, Postmenopausal
Drug: Risedronate
Drug: Raloxifene
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the effects of risedronate, raloxifene, and placebo on BMD of the hip [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: June 2004
Study Completion Date: October 2004
Arms Assigned Interventions
Experimental: 1
Risedronate 35mg once a week
Drug: Risedronate
Active Comparator: 2
Raloxifene 60mg daily
Drug: Raloxifene
Placebo Comparator: 3 Other: Placebo

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790101

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Tara Semanchik Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00790101     History of Changes
Other Study ID Numbers: HMR4003B_4033
Study First Received: November 11, 2008
Last Updated: January 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Raloxifene
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014