OsteoporosisOPUSNCT00665860
Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss
A study testing Soy isoflavones in people with Osteoporosis, run by Baylor College of Medicine at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- 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
- 403 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2001to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be able to swallow the pills
- No menses for 12 months
- Blood follicle stimulating hormone great than 30 IU/mL
- Lumbar spine bone mineral density t-score equal to or greater than -1.5
Who cannot join
- Strict vegetarians
- Current or recent smokers (within last five years)
- Abnormal screening mammogram, Pap smear and blood chemistries
- Clinical diagnosis of osteoporosis, spine and/or hip fracture, cancer, liver, kidney, gallbladder and heart disease
- Clinical diagnosis of psychiatric disorder
- Any allergic reactions to soy products
- Current treatment with bisphosphonates, calcitonin, fluoride, corticosteroids, tamoxifen, raloxifene, HRT, premarin, farestron and letrozole
- Current usage of black cohosh, blue cohosh, dong quai, Caltrate 600+Soy, Estroven, ginseng, Healthy Women, Natural Estrogen, Opti-Soy, PhytoFem, Probalance, Promensil, Remifemin, Rimostil and Trinovin
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Georgia
Athens, Georgia, 30602
University of California
Davis, California, 95616
Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent Osteoporosis
The purpose of this study is to determine whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women.
Read the detailed description
Over-the-counter soy isoflavone supplement usage is becoming common among postmenopausal women. However, there is no documented scientific evidence of its long-term safety and efficacy in preventing osteoporosis. Our primary goal is to determine the safety, efficacy, and optimal dosage of isoflavone supplementation to reduce bone loss in postmenopausal women. The multi-state, multi-institutional design ensures that the study results are representative of postmenopausal women in the U.S. population. Confirming the skeletal benefits of soy isoflavones could translate into reduced healthcare costs related to osteoporosis.
- Conditions
- Osteoporosis
- Being tested
- Placebo, Soy isoflavones
- Keywords
- Osteoporosis, Soy isoflavones, Postmenopausal women, Safety, Efficacy, Effective dosage
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Three pills per day for two years
Soy isoflavonesDietary supplement
Also called Soy germ isoflavones
Three pills that delivered 80 mg of aglycone isoflavones per day for two years
Soy isoflavonesDietary supplement
Also called Soy germ isoflavones
Three pills that delivered 120 mg aglycone isoflavones per day for two years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| 2 | Active comparator | Not described Receives: Dietary Supplement: Soy isoflavones |
| 3 | Active comparator | Not described Receives: Dietary Supplement: Soy isoflavones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: One year and two years
Secondary outcomes (1)
Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen)
Measured: One year and two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startApr 2001
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Kaiser Foundation Research Institute, University of Georgia, University of Alabama at Birmingham, Texas A&M University
- Responsible party
- Principal investigator, William Wong, Baylor College of Medicine
- Investigators
- William W. Wong, Ph.D., Study director, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665860
- Sponsor's protocol ID
- TEXW-2001-04550
- Other IDs
- 2001-52102-11255, 2001
- Acronym
- OPUS
- Status last verified
- Nov 2020
- First submitted
- 22 Apr 2008
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ellis KJ, Shypailo RS, Steinberg FM, Lewis RD, Young RL, Wong WW. Reproducibility of fan-beam DXA measurements in adults and phantoms. J Clin Densitom. 2004 Winter;7(4):413-8. doi: 10.1385/jcd:7:4:413.
PubMed 15618602Steinberg FM, Murray MJ, Lewis RD, Cramer MA, Amato P, Young RL, Barnes S, Konzelmann KL, Fischer JG, Ellis KJ, Shypailo RJ, Fraley JK, Smith EO, Wong WW. Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women. Am J Clin Nutr. 2011 Feb;93(2):356-67. doi: 10.3945/ajcn.110.008359. Epub 2010 Dec 22.
PubMed 21177797Wong WW, Lewis RD, Steinberg FM, Murray MJ, Cramer MA, Amato P, Young RL, Barnes S, Ellis KJ, Shypailo RJ, Fraley JK, Konzelmann KL, Fischer JG, Smith EO. Soy isoflavone supplementation and bone mineral density in menopausal women: a 2-y multicenter clinical trial. Am J Clin Nutr. 2009 Nov;90(5):1433-9. doi: 10.3945/ajcn.2009.28001. Epub 2009 Sep 16.
PubMed 19759166
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent Osteoporosis
- ClinicalTrials.gov ID
- NCT00665860
- Acronym / sponsor ID
- OPUS / TEXW-2001-04550
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Soy isoflavones, Postmenopausal women, Safety, Efficacy, Effective dosage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of California, Kaiser Foundation Research Institute, University of Georgia, University of Alabama at Birmingham, Texas A&M University
- Study start
- Apr 2001
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
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 whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women.
Detailed description
Over-the-counter soy isoflavone supplement usage is becoming common among postmenopausal women. However, there is no documented scientific evidence of its long-term safety and efficacy in preventing osteoporosis. Our primary goal is to determine the safety, efficacy, and optimal dosage of isoflavone supplementation to reduce bone loss in postmenopausal women. The multi-state, multi-institutional design ensures that the study results are representative of postmenopausal women in the U.S. population. Confirming the skeletal benefits of soy isoflavones could translate into reduced healthcare costs related to osteoporosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| 2 | Active comparator | Dietary Supplement: Soy isoflavones |
| 3 | Active comparator | Dietary Supplement: Soy isoflavones |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must be able to swallow the pills
- No menses for 12 months
- Blood follicle stimulating hormone great than 30 IU/mL
- Lumbar spine bone mineral density t-score equal to or greater than -1.5
Key exclusion criteria (8 listed)
- Strict vegetarians
- Current or recent smokers (within last five years)
- Abnormal screening mammogram, Pap smear and blood chemistries
- Clinical diagnosis of osteoporosis, spine and/or hip fracture, cancer, liver, kidney, gallbladder and heart disease
- Clinical diagnosis of psychiatric disorder
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 |
|---|---|---|
| PlaceboThree pills per day for two years | Dietary supplement | 1 |
| Soy isoflavonesAlso: Soy germ isoflavonesThree pills that delivered 80 mg of aglycone isoflavones per day for two years | Dietary supplement | 2 |
| Soy isoflavonesAlso: Soy germ isoflavonesThree pills that delivered 120 mg aglycone isoflavones per day for two years | Dietary supplement | 3 |
Primary outcome
Bone mineral density
Time frame: One year and two years
1 secondary outcome
Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen)
Time frame: One year and two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Results publication: PubMed 15618602Ellis KJ, Shypailo RS, Steinberg FM, Lewis RD, Young RL, Wong WW. Reproducibility of fan-beam DXA measurements in adults and phantoms. J Clin Densitom. 2004 Winter;7(4):413-8. doi: 10.1385/jcd:7:4:413.
- Derived from this study: PubMed 21177797Steinberg FM, Murray MJ, Lewis RD, Cramer MA, Amato P, Young RL, Barnes S, Konzelmann KL, Fischer JG, Ellis KJ, Shypailo RJ, Fraley JK, Smith EO, Wong WW. Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women. Am J Clin Nutr. 2011 Feb;93(2):356-67. doi: 10.3945/ajcn.110.008359. Epub 2010 Dec 22.
- Derived from this study: PubMed 19759166Wong WW, Lewis RD, Steinberg FM, Murray MJ, Cramer MA, Amato P, Young RL, Barnes S, Ellis KJ, Shypailo RJ, Fraley JK, Konzelmann KL, Fischer JG, Smith EO. Soy isoflavone supplementation and bone mineral density in menopausal women: a 2-y multicenter clinical trial. Am J Clin Nutr. 2009 Nov;90(5):1433-9. doi: 10.3945/ajcn.2009.28001. Epub 2009 Sep 16.
- Click here for more information on this study: Osteoporosis Prevention Using Soy (OPUS)Link provided by the sponsor.
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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.
William W. Wong, Ph.D. study director
Baylor College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy isoflavones in people with Osteoporosis, run by Baylor College of Medicine at 3 sites 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 4 inclusion and 8 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 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone mineral density (time frame: One year and two 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 NCT00665860, which also lists 3 linked publications.
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 27 Nov 2020.