MenopausePhase 3SPARENCT00076050
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
A Phase 3 study testing Soy isoflavones in people with Menopause and Osteoporosis, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Osteoporosis, Osteopenia
- What is being tested?
- Soy isoflavones
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jun 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami School of Medicine
Miami, Florida, 33136
About this study
Official 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.
Read the detailed description
The risks of bone loss and osteoporosis increase significantly after menopause. Although hormone therapy (HT) can spare menopausal women from bone loss and other menopausal symptoms, Women's Health Initiative (WHI) findings indicate significant potential health risks associated with HT. This has prompted women to switch from HT to naturally occurring compounds similar to estrogen, such as those derived from soy, in the hope that estrogens from plant sources can provide benefits while sparing adverse effects caused by prescribed estrogens. However, the long-term efficacy and safety of plant estrogens are unknown. This study will evaluate the effectiveness of treatment using purified soy isoflavones, a dietary source of phytoestrogens, in preventing bone loss, menopausal symptoms, and other changes associated with estrogen deficiency in young menopausal women. The "Soy Phytoestrogens As Replacement Estrogen (SPARE)" study will provide a foundation of knowledge from which menopausal women and their doctors can begin to make more informed decisions regarding HT and other treatment options.
Enrollment into the study will occur over 3 years, with each participant taking part in the study for a total of 2 years. Participants will be randomly assigned to one of two groups; the first group will receive a 200 mg dose of soy isoflavones daily and the second group will receive placebo daily. There will be 10 study visits: screening, study entry, randomization at Month 1, six follow-up visits at Months 2, 4, 8, 12, 16, 20, and a final visit at the end of active participation at Month 24. At each study visit, participants will have blood drawn, provide urine samples, answer questionnaires, and have mammograms and bone density tests.
- Conditions
- Menopause, Osteoporosis, Osteopenia
- Being tested
- Soy isoflavones, Placebo
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy isoflavonesDietary supplement
Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.
PlaceboDietary supplement
Placebo soy isoflavones
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive a 200-mg dose of soy isoflavones daily over 2 years. Receives: Dietary Supplement: Soy isoflavones |
| 2 | Placebo comparator | Participants will receive placebo daily over 2 years. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Bone Mineral Density
Measured: baseline and 2 years
Secondary outcomes (2)
Changes in Women's Health Questionnaire Score
This self-administered questionnaire contains 23 items, distributed among 6 factors: anxiety and depressed mood (7 items), well-being (4 items), somatic symptoms (5 items), memory and concentration (3 items), vasomotor symptoms (2 items) and sleep problems (2 items). The instrument has a structured format and the response choices consist of 4-point Likert scales ('yes definitely' to 'no, not at all'). Item scores are collapsed into a dichotomous scale, where higher scores indicate a greater level of symptomatology or difficulty; i.e., if the response is 1 or 2 (positive response), the score = 1; if the response is 3 or 4 (negative response), the score is 0. Results can be reported as a total score, where the range is 0-23, but also for each dimension. Thus, the ranges of the subscales are: for anxiety and mood 0-7, for well-being 0-4, somatic symptoms 0-5, memory and concentration 0-3, vasomotor symptoms 0-2 and sleep problems 0-2.
Measured: baseline and 2 years
Change in Vaginal Maturation Value
The Vaginal Maturation Value (VMV) describes the proportion of the three vaginal epithelial cell types (parabasal, intermediate and superficial) obtained from a swab of the vaginal walls. The changes in the proportion of each type of cells reflects the degree of exposure to estrogen of the vaginal epithelium. The VMV lists the percentage of each type of cell appearing on the smear, with the total of all three values equaling 100%. The index is read from left to right; i.e. VMI of 5/40/55 represents 5% parabasal cells, 40% intermediate cells and 55% superficial cells. Exposure to estrogens results in some parabasal cells, a greater proportion of intermediate cells and few superficial cells.
Measured: baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2004 (estimated)
- Study startSep 2003
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Silvina Levis, MD, University of Miami
- Investigators
- Silvina Levis, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076050
- Sponsor's protocol ID
- R01AR048932
- Other IDs
- R01AR048932, NIAMS-114, SPARE
- Acronym
- SPARE
- Status last verified
- Oct 2016
- First submitted
- 13 Jan 2004
- Last updated
- 6 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Levis S, Strickman-Stein N, Ganjei-Azar P, Xu P, Doerge DR, Krischer J. Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial. Arch Intern Med. 2011 Aug 8;171(15):1363-9. doi: 10.1001/archinternmed.2011.330.
PubMed 21824950
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Sparing Effects of Soy Phytoestrogens in Menopause
- ClinicalTrials.gov ID
- NCT00076050
- Acronym / sponsor ID
- SPARE / R01AR048932
- Conditions
- Menopause, Osteoporosis, Osteopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Sep 2003
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Jan 2004 (estimated)
- Results
- Posted 6 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The risks of bone loss and osteoporosis increase significantly after menopause. Although hormone therapy (HT) can spare menopausal women from bone loss and other menopausal symptoms, Women's Health Initiative (WHI) findings indicate significant potential health risks associated with HT. This has prompted women to switch from HT to naturally occurring compounds similar to estrogen, such as those derived from soy, in the hope that estrogens from plant sources can provide benefits while sparing adverse effects caused by prescribed estrogens. However, the long-term efficacy and safety of plant estrogens are unknown. This study will evaluate the effectiveness of treatment using purified soy isoflavones, a dietary source of phytoestrogens, in preventing bone loss, menopausal symptoms, and other changes associated with estrogen deficiency in young menopausal women. The "Soy Phytoestrogens As Replacement Estrogen (SPARE)" study will provide a foundation of knowledge from which menopausal women and their doctors can begin to make more informed decisions regarding HT and other treatment options.
Enrollment into the study will occur over 3 years, with each participant taking part in the study for a total of 2 years. Participants will be randomly assigned to one of two groups; the first group will receive a 200 mg dose of soy isoflavones daily and the second group will receive placebo daily. There will be 10 study visits: screening, study entry, randomization at Month 1, six follow-up visits at Months 2, 4, 8, 12, 16, 20, and a final visit at the end of active participation at Month 24. At each study visit, participants will have blood drawn, provide urine samples, answer questionnaires, and have mammograms and bone density tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Soy isoflavonesParticipants will receive a 200-mg dose of soy isoflavones daily over 2 years. |
| 2 | Placebo comparator | Dietary Supplement: PlaceboParticipants will receive placebo daily over 2 years. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy isoflavonesPurified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg. | Dietary supplement | 1 |
| PlaceboPlacebo soy isoflavones | Dietary supplement | 2 |
Primary outcome
Change From Baseline in Bone Mineral Density
Time frame: baseline and 2 years
2 secondary outcomes
Changes in Women's Health Questionnaire Score
Time frame: baseline and 2 years
Change in Vaginal Maturation Value
Time frame: baseline and 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21824950Levis S, Strickman-Stein N, Ganjei-Azar P, Xu P, Doerge DR, Krischer J. Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial. Arch Intern Med. 2011 Aug 8;171(15):1363-9. doi: 10.1001/archinternmed.2011.330.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvina Levis, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Soy isoflavones in people with Menopause and Osteoporosis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Bone Mineral Density (time frame: baseline and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00076050, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.