Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation

NCT00790101 | Terminated Phase 4

• 1 other identifier: HMR4003B_4033
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 anabolic activity in postmenopausal women who previously received HRT.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Compare the effects of risedronate, raloxifene, and placebo on BMD of the hip

Study Arms (3)

1

EXPERIMENTAL

Risedronate 35mg once a week

Drug: Risedronate

2

ACTIVE COMPARATOR

Raloxifene 60mg daily

Drug: Raloxifene

3

PLACEBO COMPARATOR

Other: Placebo

Interventions

Risedronate DRUG

1

Raloxifene DRUG

2

Placebo OTHER

3

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronic Acid; Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Tara Semanchik

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 11, 2008
• First Posted: November 13, 2008
• Study Start: June 1, 2004
• Study Completion: October 1, 2004
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)