OsteoporosisPhase 1NCT00244907
Isoflavones for Promoting Calcium Absorption and Preventing Bone Loss in Post Menopausal Women
A Phase 1 study testing Genistein vs Risedronate in people with Osteoporosis and Osteopenia, run by Purdue University at 1 site in United States.
Trial summary
Estrogen is a hormone that helps prevent calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide protection against bone loss. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Genistein vs Risedronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2010
- Phase
- Phase 1
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At least 4 years post-menopausal
Who cannot join
- Not currently taking estrogen replacement therapy or undergoing any treatment for osteoporosis
- Diagnosis of breast cancer
- Results of mammogram suggesting breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolism and Bone Health
Estrogen is a hormone that helps prevent calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide protection against bone loss. This study will evaluate the effect of soy isoflavones on calcium absorption and bone loss in post menopausal women.
Read the detailed description
Estrogen is a hormone that activates bone-forming cells and prevents calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may accelerate bone breakdown and inhibit the body's ability to create new bone, thereby leading to bone loss and possibly osteoporosis. Various treatments have been developed to decrease bone loss in post-menopausal women. Actonel, for example, is an FDA-approved drug used to help prevent bone loss.
Phytoestrogens are plant compounds with a structure similar to estrogen. They have also been shown to help reduce the negative effects of menopause. Isoflavones are a particular type of phytoestrogens that are found in soy plants and may act like estrogen in providing possible protection against bone loss. This study will compare the effects of isoflavones (including genistein, a type of isoflavone) versus Actonel on calcium absorption and bone loss in post-menopausal women.
Participants in this double-blind cross-over study will first complete a screening process, which will include answering questions about their health habits, medical history, physical activity, and food patterns. They will then eat one soy bar daily for 3 days. On Day 4, a urine sample will be taken to assess their ability to metabolize phytoestrogen from soybeans. Participants will be randomly assigned to a specific treatment order. Participants will receive 1-4 unique soy isoflavones, followed by Actonel. Treatment phases will be separated by a 50-day washout period. All participants will also take calcium and vitamin D supplements throughout the study. Assessments will include bone density measurements, calcium absorption tests, and blood and urine tests. The study will last approximately 2.5 years.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- Genistein vs Risedronate
- Keywords
- Bone Resorption, Phytoestrogens, Calcium, Genistein, Equol
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genistein vs RisedronateDietary supplement
Also called Actonel
Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)
| Study group | Role | What they receive |
|---|---|---|
| Genistein vs. Risedronate | Active comparator | Healthy post menopausal women who have been dosed with Ca41. Intervention, 100 mg Gensitein from soy protein isolate for 50 days. After a 50 day washout risedronate (Actonel- 5mg per day) for 50 days Receives: Dietary Supplement: Genistein vs Risedronate |
| Genistein dose and source | Active comparator | Healthy post menopausal women will consume 5 products containing varying quantities of genistein from different sources for 50 days each in a randomized order. Each intervention period is separated by a 50 day washout period. Intervention: A) 50 mg genistein from soy protein isolate, B) 100 mg genistein from soy protein isolate, C)50 mg genistein from Novasoy, D) 100 mg genistein from Novasoy, E) 100 ng genistein from 50% Novasoy and 50% soy protein isolate Receives: Dietary Supplement: Genistein vs Risedronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary markers of bone resorption; measured at the end of each treatment phase
Measured: Every 50 days
Secondary outcomes (1)
Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phase
Measured: Every 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startJan 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Responsible party
- Principal investigator, Berdine Martin, Purdue University
- Investigators
- Connie M. Weaver, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244907
- Sponsor's protocol ID
- P50AT000477-06
- Other IDs
- P50AT000477-06
- Status last verified
- May 2018
- First submitted
- 25 Oct 2005
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spence LA, Lipscomb ER, Cadogan J, Martin B, Wastney ME, Peacock M, Weaver CM. The effect of soy protein and soy isoflavones on calcium metabolism in postmenopausal women: a randomized crossover study. Am J Clin Nutr. 2005 Apr;81(4):916-22. doi: 10.1093/ajcn/81.4.916.
PubMed 15817872Jackson GS, Weaver C, Elmore D. Use of accelerator mass spectrometry for studies in nutrition. Nutr Res Rev. 2001 Dec;14(2):317-34. doi: 10.1079/NRR200129.
PubMed 19087429Pawlowski JW, Martin BR, McCabe GP, McCabe L, Jackson GS, Peacock M, Barnes S, Weaver CM. Impact of equol-producing capacity and soy-isoflavone profiles of supplements on bone calcium retention in postmenopausal women: a randomized crossover trial. Am J Clin Nutr. 2015 Sep;102(3):695-703. doi: 10.3945/ajcn.114.093906. Epub 2015 Aug 5.
PubMed 26245807Nakatsu CH, Armstrong A, Clavijo AP, Martin BR, Barnes S, Weaver CM. Fecal bacterial community changes associated with isoflavone metabolites in postmenopausal women after soy bar consumption. PLoS One. 2014 Oct 1;9(10):e108924. doi: 10.1371/journal.pone.0108924. eCollection 2014.
PubMed 25271941
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism and Bone Health
- ClinicalTrials.gov ID
- NCT00244907
- Acronym / sponsor ID
- P50AT000477-06
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Bone Resorption, Phytoestrogens, Calcium, Genistein, Equol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Study start
- Jan 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Oct 2005 (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.
Estrogen is a hormone that helps prevent calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide protection against bone loss. This study will evaluate the effect of soy isoflavones on calcium absorption and bone loss in post menopausal women.
Detailed description
Estrogen is a hormone that activates bone-forming cells and prevents calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may accelerate bone breakdown and inhibit the body's ability to create new bone, thereby leading to bone loss and possibly osteoporosis. Various treatments have been developed to decrease bone loss in post-menopausal women. Actonel, for example, is an FDA-approved drug used to help prevent bone loss.
Phytoestrogens are plant compounds with a structure similar to estrogen. They have also been shown to help reduce the negative effects of menopause. Isoflavones are a particular type of phytoestrogens that are found in soy plants and may act like estrogen in providing possible protection against bone loss. This study will compare the effects of isoflavones (including genistein, a type of isoflavone) versus Actonel on calcium absorption and bone loss in post-menopausal women.
Participants in this double-blind cross-over study will first complete a screening process, which will include answering questions about their health habits, medical history, physical activity, and food patterns. They will then eat one soy bar daily for 3 days. On Day 4, a urine sample will be taken to assess their ability to metabolize phytoestrogen from soybeans. Participants will be randomly assigned to a specific treatment order. Participants will receive 1-4 unique soy isoflavones, followed by Actonel. Treatment phases will be separated by a 50-day washout period. All participants will also take calcium and vitamin D supplements throughout the study. Assessments will include bone density measurements, calcium absorption tests, and blood and urine tests. The study will last approximately 2.5 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genistein vs. Risedronate | Active comparator | Dietary Supplement: Genistein vs RisedronateHealthy post menopausal women who have been dosed with Ca41. Intervention, 100 mg Gensitein from soy protein isolate for 50 days. After a 50 day washout risedronate (Actonel- 5mg per day) for 50 days |
| Genistein dose and source | Active comparator | Dietary Supplement: Genistein vs RisedronateHealthy post menopausal women will consume 5 products containing varying quantities of genistein from different sources for 50 days each in a randomized order. Each intervention period is separated by a 50 day washout period. Intervention: A) 50 mg genistein from soy protein isolate, B) 100 mg genistein from soy protein isolate, C)50 mg genistein from Novasoy, D) 100 mg genistein from Novasoy, E) 100 ng genistein from 50% Novasoy and 50% soy protein isolate |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- At least 4 years post-menopausal
Key exclusion criteria (3 listed)
- Not currently taking estrogen replacement therapy or undergoing any treatment for osteoporosis
- Diagnosis of breast cancer
- Results of mammogram suggesting breast cancer
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 |
|---|---|---|
| Genistein vs RisedronateAlso: ActonelGensitein (100 gm) from soy protein isolate Risedronate (5 mg) | Dietary supplement | Genistein dose and source, Genistein vs. Risedronate |
Primary outcome
Urinary markers of bone resorption; measured at the end of each treatment phase
Time frame: Every 50 days
1 secondary outcome
Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phase
Time frame: Every 50 days
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 4 May 2018.
- Background: PubMed 15817872Spence LA, Lipscomb ER, Cadogan J, Martin B, Wastney ME, Peacock M, Weaver CM. The effect of soy protein and soy isoflavones on calcium metabolism in postmenopausal women: a randomized crossover study. Am J Clin Nutr. 2005 Apr;81(4):916-22. doi: 10.1093/ajcn/81.4.916.
- Background: PubMed 19087429Jackson GS, Weaver C, Elmore D. Use of accelerator mass spectrometry for studies in nutrition. Nutr Res Rev. 2001 Dec;14(2):317-34. doi: 10.1079/NRR200129.
- Derived from this study: PubMed 26245807Pawlowski JW, Martin BR, McCabe GP, McCabe L, Jackson GS, Peacock M, Barnes S, Weaver CM. Impact of equol-producing capacity and soy-isoflavone profiles of supplements on bone calcium retention in postmenopausal women: a randomized crossover trial. Am J Clin Nutr. 2015 Sep;102(3):695-703. doi: 10.3945/ajcn.114.093906. Epub 2015 Aug 5.
- Derived from this study: PubMed 25271941Nakatsu CH, Armstrong A, Clavijo AP, Martin BR, Barnes S, Weaver CM. Fecal bacterial community changes associated with isoflavone metabolites in postmenopausal women after soy bar consumption. PLoS One. 2014 Oct 1;9(10):e108924. doi: 10.1371/journal.pone.0108924. eCollection 2014.
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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.
Connie M. Weaver, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Genistein vs Risedronate in people with Osteoporosis and Osteopenia, run by Purdue University 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 3 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 4 May 2018. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Urinary markers of bone resorption; measured at the end of each treatment phase (time frame: Every 50 days). 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 NCT00244907, which also lists 4 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 4 May 2018.