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Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis (MORE)

Primary Purpose

Osteoporosis, Postmenopausal

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Raloxifene HCL

Placebo

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Ambulatory postmenopausal women free of severe or chronically disabling conditions, have a life expectancy of at least 5 years, be expected to remain ambulatory throughout the entire study, and be expected to return for follow-up visits.
Women who have had their last menstrual period at least 2 years before beginning the study.
Women who have no language barrier, are cooperative, and who give informed consent before entering the study
Substudy 1:Femoral neck or lumbar spine BMD measurements 2.5 or more standard deviations below normal peak bone mass for healthy, premenopausal women (T-score greater then or equal to 2.5).
Substudy 2:Either at least one moderate or at least two mild vertebral fractures in the presence of low BMD (as specified above) or at least two moderate vertebral fractures, regardless of BMD.

Exclusion Criteria:

Patients with known current bone disorders other than primary osteoporosis, such as hyperparathyroidism, Paget's disease, renal osteodystrophy, or osteomalacia
Patients experiencing clinically severe postmenopausal symptoms at the beginning of the study that require estrogen-replacement therapy
Patients with known, suspected, or history of carcinoma of the breast or estrogen-dependent neoplasia
Patients who have had any history of cancer within the previous 5 years
Patients with abnormal uterine bleeding
Patients with a history of deep venous thrombosis, thromboembolic disorders, or cerebral vascular accident within the past 10 years except for patients with a history of deep venous thrombosis due to accidents
Patients who have endocrine disorders requiring pharmacologic therapy except for type II diabetes
Patients who are not biochemically euthyroid or who have had changes in thyroid replacement therapy in the 2 months before the start of the study.
Patients with acute or chronic liver disease
Patients who have impaired kidney function
Patients with active renal lithiasis
Patients with known, severe untreated malabsorption syndromes
Patients with pathologic fractures (both substudies) or patients in Substudy II all of whose vertebral fractures are clearly a result of automobile accidents or other severely traumatic accidents
Patients in whom satisfactory baseline thoracic and lumbar x-ray views cannot be obtained
Patients with less than two lumbar and less than four thoracic vertebrae that are unfractured and evaluable for incident fractures
Treatment with therapeutic doses of any of the following medications more recently than 6 months before beginning the study: Androgen, Calcitonin, Estrogen, Progestin
Treatment with therapeutic doses of systemic corticosteroids for more than 1 month during the 12 months before beginning the study.
Patients who have received therapeutic doses of fluorides
Patients who have received bisphosphonate therapy for more than 14 days during the past 18 months or who have received any bisphosphonate therapy within the last 6 months before beginning the study.
Patients requiring high-dose heparinization (>7500 U/day) at study entry for a total period of time that will presumably exceed 6 months
Patients being treated with 50,000 IU or more of vitamin D once weekly more recently than 3 months before beginning the study will be excluded.
Current systemic treatment with any of the following medications at the beginning of the study: Lithium, Anticonvulsants, regular use of phosphate-binding antacids.

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Raloxifene HCL 60 mg orally once a day

Raloxifene HCL 120 mg orally once a day

Outcomes

Primary Outcome Measures

To establish the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without prevalent vertebral fractures by spinal x-ray.

To establish the effect of long-term treatment with raloxifene, compared with placebo, on lumbar spine and femoral neck bone mineral density (BMD) in postmenopausal women with osteoporosis.

To establish the safety of chronic administration of raloxifene in postmenopausal women with osteoporosis. Adverse events (AEs), physical exam (PE), EKG, mammograms and laboratory tests will be used to assess safety in the patients.

Secondary Outcome Measures

To establish the effect of long-term treatment with raloxifene, compared with placebo, on total body bone mineral content and radial BMD in postmenopausal women with osteoporosis.

To establish the effect of raloxifene, compared with placebo, on the rates of new nonvertebral fractures alone & of nonvertebral & vertebral fractures combined in postmenopausal women with osteoporosis by spinal x-ray & assessment of clinical fractures.

To establish the effect of long-term treatment with raloxifene, compared with placebo, on biochemical markers of bone metabolism in postmenopausal women with osteoporosis.

To establish the effect of long-term treatment with raloxifene, compared with placebo, on serum lipids and other laboratory markers of cardiovascular risk in postmenopausal women with osteoporosis.

To quantify medical resources utilized by patients treated with raloxifene so that a subsequent incremental cost-effectiveness analysis can be performed by quantifying overnight hospitalizations or osteoporotic fractures.

To assess the impact of raloxifene on quality of life in osteoporotic women with prevalent vertebral fractures by the completion of Quality of Life instruments.

To assess the impact of raloxifene on cognitive & neuropsychomotor function using a standardized battery of neuropsychometric tests.

To assess the impact of treatment with raloxifene on risk of cardiovascular disease by monitoring biochemical markers of cardiovascular risk.

To assess the possible impact of long-term treatment with raloxifene on risks of endometrial cancer by pelvic gynecological exams and by use of uterine ultrasound in a subset of patients.

To assess the possible impact of long-term treatment with raloxifene on breast cancer.

To determine the effect of treatment with raloxifene on the prevalence of Alzheimer's disease (AD) on subjects by using a Dementia Diagnostic Evaluation which includes a battery of tests and interviews with the patient as well as brain CT or MRI scan.

To determine the effect of long-term treatment with raloxifene on the prevalence of dementia associated with cerebrovascular (CV) disease in postmenopausal women with osteoporosis by administration of the dementia diagnosis.

Determine the effect of raloxifene on the prevalence of all causes of dementia in subjects by using a Dementia Diagnostic Evaluation which includes a battery of tests and interviews with the patient as well as brain CT or MRI scan.

Full Information

NCT ID

NCT00670319

First Posted

April 29, 2008

Last Updated

April 30, 2008

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00670319

Brief Title

Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

Acronym

Official Title

Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

November 1994 (undefined)

Primary Completion Date

September 1999 (Actual)

Study Completion Date

September 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Postmenopausal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

7705 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Raloxifene HCL 60 mg orally once a day

Arm Title

Arm Type

Experimental

Arm Description

Raloxifene HCL 120 mg orally once a day

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Raloxifene HCL

Other Intervention Name(s)

Evista, LY139481

Intervention Description

Raloxifene HCL 60 mg orally once daily

Intervention Type

Drug

Intervention Name(s)

Raloxifene HCL

Other Intervention Name(s)

Evista, LY139481

Intervention Description

Raloxifene HCL 120 mg orally once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo one tab orally per day

Primary Outcome Measure Information:

Title

Time Frame

Screening, 24, 36, and 72 months

Title

To establish the effect of long-term treatment with raloxifene, compared with placebo, on lumbar spine and femoral neck bone mineral density (BMD) in postmenopausal women with osteoporosis.

Time Frame

Screening, baseline, 12, 24, 36, 48, 60 and 72 months

Title

Time Frame

AEs: throughout the trial. PEs: Randomization, 12, 24, 36, 48, 60, 72 months. ECG: Randomization, 24, 48, 72 months. Mammograms: Randomization, 12, 24, 36, 48, 60, 72 months. Labs: Randomization, baseline, 6, 12, 18, 24, 30, 36, 48, 60, 72 months.

Secondary Outcome Measure Information:

Title

To establish the effect of long-term treatment with raloxifene, compared with placebo, on total body bone mineral content and radial BMD in postmenopausal women with osteoporosis.

Time Frame

Baseline, 24 and 72 months

Title

Time Frame

Spinal X-rays: Screening, 24, 36 and 72 months. Assessment of clinical fractures: throughout the trial

Title

To establish the effect of long-term treatment with raloxifene, compared with placebo, on biochemical markers of bone metabolism in postmenopausal women with osteoporosis.

Time Frame

Randomization, baseline, 6, 12, 24, 36, and 72 months

Title

To establish the effect of long-term treatment with raloxifene, compared with placebo, on serum lipids and other laboratory markers of cardiovascular risk in postmenopausal women with osteoporosis.

Time Frame

Baseline, 6, 12, 24, 36, and 48 months

Title

Time Frame

Baseline, 3, 6, 12, 18, 24,30 and 36 months

Title

To assess the impact of raloxifene on quality of life in osteoporotic women with prevalent vertebral fractures by the completion of Quality of Life instruments.

Time Frame

Baseline, 12, 24, and 36 months

Title

To assess the impact of raloxifene on cognitive & neuropsychomotor function using a standardized battery of neuropsychometric tests.

Time Frame

Cognitive/Neuropsychomotor assessments: Baseline, 6, 12, 24, 36, 48, 60 and 72 months

Title

To assess the impact of treatment with raloxifene on risk of cardiovascular disease by monitoring biochemical markers of cardiovascular risk.

Time Frame

Baseline, 6, 12, 24, 36, and 48 months

Title

To assess the possible impact of long-term treatment with raloxifene on risks of endometrial cancer by pelvic gynecological exams and by use of uterine ultrasound in a subset of patients.

Time Frame

GYN Exams and Uterine Ultrasound: Screening, 12, 24, 36, 48, 60 and 72 months.

Title

To assess the possible impact of long-term treatment with raloxifene on breast cancer.

Time Frame

Mammograms: Screening, 24, 36,48 60 and 72 months

Title

Time Frame

Ongoing throughout the trial

Title

Time Frame

Ongoing throughout the trial

Title

Time Frame

Ongoing throughout the trial

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ambulatory postmenopausal women free of severe or chronically disabling conditions, have a life expectancy of at least 5 years, be expected to remain ambulatory throughout the entire study, and be expected to return for follow-up visits. Women who have had their last menstrual period at least 2 years before beginning the study. Women who have no language barrier, are cooperative, and who give informed consent before entering the study Substudy 1:Femoral neck or lumbar spine BMD measurements 2.5 or more standard deviations below normal peak bone mass for healthy, premenopausal women (T-score greater then or equal to 2.5). Substudy 2:Either at least one moderate or at least two mild vertebral fractures in the presence of low BMD (as specified above) or at least two moderate vertebral fractures, regardless of BMD. Exclusion Criteria: Patients with known current bone disorders other than primary osteoporosis, such as hyperparathyroidism, Paget's disease, renal osteodystrophy, or osteomalacia Patients experiencing clinically severe postmenopausal symptoms at the beginning of the study that require estrogen-replacement therapy Patients with known, suspected, or history of carcinoma of the breast or estrogen-dependent neoplasia Patients who have had any history of cancer within the previous 5 years Patients with abnormal uterine bleeding Patients with a history of deep venous thrombosis, thromboembolic disorders, or cerebral vascular accident within the past 10 years except for patients with a history of deep venous thrombosis due to accidents Patients who have endocrine disorders requiring pharmacologic therapy except for type II diabetes Patients who are not biochemically euthyroid or who have had changes in thyroid replacement therapy in the 2 months before the start of the study. Patients with acute or chronic liver disease Patients who have impaired kidney function Patients with active renal lithiasis Patients with known, severe untreated malabsorption syndromes Patients with pathologic fractures (both substudies) or patients in Substudy II all of whose vertebral fractures are clearly a result of automobile accidents or other severely traumatic accidents Patients in whom satisfactory baseline thoracic and lumbar x-ray views cannot be obtained Patients with less than two lumbar and less than four thoracic vertebrae that are unfractured and evaluable for incident fractures Treatment with therapeutic doses of any of the following medications more recently than 6 months before beginning the study: Androgen, Calcitonin, Estrogen, Progestin Treatment with therapeutic doses of systemic corticosteroids for more than 1 month during the 12 months before beginning the study. Patients who have received therapeutic doses of fluorides Patients who have received bisphosphonate therapy for more than 14 days during the past 18 months or who have received any bisphosphonate therapy within the last 6 months before beginning the study. Patients requiring high-dose heparinization (>7500 U/day) at study entry for a total period of time that will presumably exceed 6 months Patients being treated with 50,000 IU or more of vitamin D once weekly more recently than 3 months before beginning the study will be excluded. Current systemic treatment with any of the following medications at the beginning of the study: Lithium, Anticonvulsants, regular use of phosphate-binding antacids.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

San Francisco

State/Province

California

Country

United States

Facility Name

City

Ciudad De Buenos Aires

Country

Argentina

Facility Name

City

Heidelburg

Country

Australia

Facility Name

City

Graz

Country

Austria

Facility Name

City

Brussels

Country

Belgium

Facility Name

City

London

State/Province

Ontario

Country

Canada

Facility Name

City

Praha

Country

Czech Republic

Facility Name

City

Aarhus

Country

Denmark

Facility Name

City

Turku

Country

Finland

Facility Name

City

Lyon

Country

France

Facility Name

City

Wiesbaden

Country

Germany

Facility Name

City

Budapest

Country

Hungary

Facility Name

City

Petach-Tiqva

Country

Israel

Facility Name

City

Firenze

Country

Italy

Facility Name

City

Mexico City

Country

Mexico

Facility Name

City

Amsterdam

Country

Netherlands

Facility Name

City

Christchurch

Country

New Zealand

Facility Name

City

Haugesund

Country

Norway

Facility Name

City

Bialystok

Country

Poland

Facility Name

City

Singapore

Country

Singapore

Facility Name

City

Bratislava

Country

Slovakia

Facility Name

City

LjublJana

Country

Slovenia

Facility Name

City

Barcelona

Country

Spain

Facility Name

City

Uppsala

Country

Sweden

Facility Name

City

London Bridge

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

20927038

Citation

Melamed ML, Blackwell T, Neugarten J, Arnsten JH, Ensrud KE, Ishani A, Cummings SR, Silbiger SR. Raloxifene, a selective estrogen receptor modulator, is renoprotective: a post-hoc analysis. Kidney Int. 2011 Jan;79(2):241-9. doi: 10.1038/ki.2010.378. Epub 2010 Oct 6.

Results Reference

derived

Learn more about this trial

Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

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