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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

7,705

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Nov 1994

Longer than P75 for phase_3

Geographic Reach

23 countries

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.8 years study duration

Study Start

First participant enrolled

November 1, 1994

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1999

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1999

Completed

8.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed

Last Updated

May 1, 2008

Status Verified

April 1, 2008

Enrollment Period

4.8 years

First QC Date

April 29, 2008

Last Update Submit

April 30, 2008

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (3)

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.
Screening, 24, 36, and 72 months
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.
Screening, baseline, 12, 24, 36, 48, 60 and 72 months
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.
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 Outcomes (13)

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.
Baseline, 24 and 72 months
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.
Spinal X-rays: Screening, 24, 36 and 72 months. Assessment of clinical fractures: throughout the trial
To establish the effect of long-term treatment with raloxifene, compared with placebo, on biochemical markers of bone metabolism in postmenopausal women with osteoporosis.
Randomization, baseline, 6, 12, 24, 36, and 72 months
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.
Baseline, 6, 12, 24, 36, and 48 months
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.
Baseline, 3, 6, 12, 18, 24,30 and 36 months
+8 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Raloxifene HCL 60 mg orally once a day

Drug: Raloxifene HCL

2

EXPERIMENTAL

Raloxifene HCL 120 mg orally once a day

Drug: Raloxifene HCL

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Raloxifene HCLDRUG

Raloxifene HCL 60 mg orally once daily

Also known as: Evista, LY139481

PlaceboDRUG

Placebo one tab orally per day

Eligibility Criteria

AgeUp to 80 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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
+7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (25)

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.

San Francisco, California, United States

Location

Ciudad de Buenos Aires, Argentina

Location

Heidelburg, Australia

Location

Graz, Austria

Location

Brussels, Belgium

Location

London, Ontario, Canada

Location

Prague, Czechia

Location

Aarhus, Denmark

Location

Turku, Finland

Location

Lyon, France

Location

Wiesbaden, Germany

Location

Budapest, Hungary

Location

Petach-Tiqva, Israel

Location

Florence, Italy

Location

Mexico City, Mexico

Location

Amsterdam, Netherlands

Location

Christchurch, New Zealand

Location

Haugesund, Norway

Location

Bialystok, Poland

Location

Singapore, Singapore

Location

Bratislava, Slovakia

Location

Ljubljana, Slovenia

Location

Barcelona, Spain

Location

Uppsala, Sweden

Location

London Bridge, United Kingdom

Location

Related Publications (1)

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.
PMID: 20927038DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 1, 2008

Study Start

November 1, 1994

Primary Completion

September 1, 1999

Study Completion

September 1, 1999

Last Updated

May 1, 2008

Record last verified: 2008-04

Locations

IT(1)NZ(1)CA(1)SG(1)AU(1)DE(1)US(1)SE(1)FI(1)BE(1)FR(1)HU(1)NL(1)PL(1)AR(1)NO(1)DK(1)IL(1)SL(1)ES(1)GB(1)CZ(1)ME(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (13)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (25)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations