Trial record 6 of 628 for:    osteoporosis AND (woman OR women OR female)

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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00670319
First received: April 29, 2008
Last updated: April 30, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Osteoporosis, Postmenopausal
Drug: Raloxifene HCL
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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. [ Time Frame: Screening, 24, 36, and 72 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. [ 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. ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Baseline, 24 and 72 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Spinal X-rays: Screening, 24, 36 and 72 months. Assessment of clinical fractures: throughout the trial ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Baseline, 3, 6, 12, 18, 24,30 and 36 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Ongoing throughout the trial ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Ongoing throughout the trial ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Ongoing throughout the trial ] [ Designated as safety issue: No ]

Enrollment: 7705
Study Start Date: November 1994
Study Completion Date: September 1999
Primary Completion Date: September 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Raloxifene HCL 60 mg orally once a day
Drug: Raloxifene HCL
Raloxifene HCL 60 mg orally once daily
Other Names:
  • Evista
  • LY139481
Experimental: 2
Raloxifene HCL 120 mg orally once a day
Drug: Raloxifene HCL
Raloxifene HCL 120 mg orally once daily
Other Names:
  • Evista
  • LY139481
Placebo Comparator: 3 Drug: Placebo
Placebo one tab orally per day

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  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: NCT00670319

  Show 25 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00670319     History of Changes
Other Study ID Numbers: 1363, H3S-MC-GGGK
Study First Received: April 29, 2008
Last Updated: April 30, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Raloxifene
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 27, 2014