Osteoporosis Clinical Trial
— SPAREOfficial title:
Bone Sparing Effects of Soy Phytoestrogens in Menopause
The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring
compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women
who have recently gone through menopause.
Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally
occurring spinal bone loss and improve biological and other emotional changes of menopause.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | June 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 60 Years |
Eligibility |
Inclusion Criteria - Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L Exclusion Criteria - Treatment with estrogens, progesterone, raloxifene, or tamoxifen - Treatment with bisphosphonates, calcitonin, fluoride, or systemic corticosteroids - Use of soy/herbal supplements, including DHEA, within 3 months prior to study entry - Use of antibiotics in the month prior to study entry - Use of prescription medication to treat hot flashes - Chemical menopause, including post-chemotherapy - Hyperthyroidism - Hypothyroidism - Uncontrolled diabetes - Malabsorption syndromes or other chronic diseases - Body mass index (BMI) less than 20 or greater than 32 - Bone mineral density (BMD) T-score below -2.0 in lumbar spine or femoral neck |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Miami School of Medicine | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of a daily dose of purified soy isoflavone in preventing the rapid spinal bone loss occurring in early menopause | 2 years | No | |
Secondary | Effectiveness in preventing hot flashes and changes in vaginal cytology, lipids, and binding globulins | yearly over 2 years | No | |
Secondary | prevention of deterioration of general health-related quality of life and emotional health status generally occurring in early menopause | over 2 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06287502 -
Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
|
N/A | |
Completed |
NCT03822078 -
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
|
Phase 1 | |
Recruiting |
NCT05845021 -
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
|
N/A | |
Completed |
NCT00092066 -
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
|
Phase 3 | |
Recruiting |
NCT04754711 -
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
|
N/A | |
Completed |
NCT04736693 -
Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
|
||
Not yet recruiting |
NCT06431867 -
Primary Care Management of Osteoporosis in Older Women
|
||
Completed |
NCT02922478 -
Role of Comorbidities in Chronic Heart Failure Study
|
||
Recruiting |
NCT02616627 -
Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
|
||
Recruiting |
NCT02635022 -
Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
|
||
Active, not recruiting |
NCT02617303 -
Prevention of Falls and Its Consequences in Elderly People
|
N/A | |
Completed |
NCT02566655 -
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
|
Phase 1 | |
Completed |
NCT02559648 -
Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis
|
Phase 2 | |
Completed |
NCT03420716 -
Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women
|
N/A | |
Not yet recruiting |
NCT02223572 -
Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture
|
N/A | |
Completed |
NCT02003716 -
DeFRA Questionnaire as an Anamnestic Form
|
N/A | |
Not yet recruiting |
NCT01854086 -
Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday
|
N/A | |
Unknown status |
NCT01913834 -
Nasally and sc Administered Teriparatide in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01694784 -
Understanding and Discouraging Overuse of Potentially Harmful Screening Tests
|
N/A | |
Completed |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A |