Osteopenic WomenPhase 1NCT01219140
Pomegranate Extract Biomarker Study in Osteopenic Women
A Phase 1 study testing 2 POMx Capsules in people with Osteopenic Women, run by POM Wonderful LLC at 1 site in United States.
Trial summary
Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate extract capsules will produce statistically significant changes in biomarkers for bone resorption and formation when compared to subjects receiving placebo. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Osteopenic Women
- What is being tested?
- 2 POMx Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women (having had their last menstrual period within the past 15 years and an appropriate serum FSH value) 45-65 years of age;
- The subject must have a T score of -1 to -2.5 at the lumbar spine or proximal femur;
- All clinical safety laboratory values at screening and randomization must be either within the reference range or be determined by the investigator and the sponsor to be abnormal, but not clinically significant;
- The patient must have provided written informed consent.
Who cannot join
- The subject has any of the following conditions: connective tissue disease, history of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrinological, urological, immunological, neurologic or psychiatric disorders, unless approved by the sponsor on a case by case basis;
- The subject has a positive test result for Hepatitis B surface antigen or antibody to hepatitis C virus at Screening;
- The subject has a known history of infection with the human immunodeficiency virus (HIV); -
- The subject has used bisphosphonate or fluoride therapy within the past 12 or 24 months, respectively;
- The subject has used denosumab within the past 24 months;
- The subject has used tibolone, parathyroid hormone (or any of its derivatives), systemic glucocorticoids or inhaled glucocorticoids, anabolic steroids or testosterone within the past 6 months;
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- The subject has used estrogens, selective estrogen receptor modulators, calcitonin or calcitriol within the past 3 months;
- The subject has hyperparathyroidism, hypoparathyroidsim, hyperthyroidism, hypothyroidism, hypocalcemia, rheumatoid arthritis, paget's disease of bone, osteomalacia;
- The subject has had a bone fracture within the past year;
- The subject has acute or chronic disease requiring frequent changes in medications or dosages of chronic therapy;
- A history of alcoholism within the last 2 years or a current history of imbibing 3 or more units of alcohol per day. (1 unit is equivalent to 1 glass of wine, 1 pint of beer, or 1 shot of hard liquor);
- The subject has participated in another study with an investigational drug or device during the 30 days prior to study entry;
- The subject has a condition interfering with his ability to provide informed consent or comply with study instructions, or the patient has a condition, which might confound the interpretation of the study result;
- The subject has a condition endangering herself if she were to participate in this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Trial to Evaluate the Safety and Efficacy of Pomegranate Extract Capsules in Post-Menopausal Subjects With Decreased Bone Mineral Density
Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate extract capsules will produce statistically significant changes in biomarkers for bone resorption and formation when compared to subjects receiving placebo.
- Conditions
- Osteopenic Women
- Being tested
- 2 POMx Capsules, 2 placebo Capsules
- Keywords
- POMx, Osteopenia, postmenopausal women, Pomegranate
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 POMx CapsulesDietary supplement
2 POMx Capsules daily
2 placebo CapsulesDietary supplement
2 placebo Capsules daily
| Study group | Role | What they receive |
|---|---|---|
| 2 POMx Capsules | Experimental | 2 POMx Capsules daily Receives: Dietary Supplement: 2 POMx Capsules |
| 2 placebo Capsules | Placebo comparator | 2 placebo Capsules daily Receives: Dietary Supplement: 2 placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers
To evaluate the impact of pomegranate extract capsules on urinary N-terminal telopeptide (NTX) and serum procollagen type 1 amino-terminal propeptide (P1NP), in post-menopausal women with decreased bone mineral density
Measured: Throughout study
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Incidence of adverse events Changes in vital signs or laboratory values
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenic WomenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- POM Wonderful LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219140
- Sponsor's protocol ID
- POM 2010-001
- Status last verified
- Oct 2010
- First submitted
- 8 Oct 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Trial to Evaluate the Safety and Efficacy of Pomegranate Extract Capsules in Post-Menopausal Subjects With Decreased Bone Mineral Density
- ClinicalTrials.gov ID
- NCT01219140
- Acronym / sponsor ID
- POM 2010-001
- Conditions
- Osteopenic Women
- Keywords
- POMx, Osteopenia, postmenopausal women, Pomegranate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- POM Wonderful LLCIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Oct 2010 (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.
Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate extract capsules will produce statistically significant changes in biomarkers for bone resorption and formation when compared to subjects receiving placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 POMx Capsules | Experimental | Dietary Supplement: 2 POMx Capsules2 POMx Capsules daily |
| 2 placebo Capsules | Placebo comparator | Dietary Supplement: 2 placebo Capsules2 placebo Capsules daily |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women (having had their last menstrual period within the past 15 years and an appropriate serum FSH value) 45-65 years of age;
- The subject must have a T score of -1 to -2.5 at the lumbar spine or proximal femur;
- All clinical safety laboratory values at screening and randomization must be either within the reference range or be determined by the investigator and the sponsor to be abnormal, but not clinically significant;
- The patient must have provided written informed consent.
Key exclusion criteria (14 listed)
- The subject has any of the following conditions: connective tissue disease, history of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrinological, urological, immunological, neurologic or psychiatric disorders, unless approved by the sponsor on a case by case basis;
- The subject has a positive test result for Hepatitis B surface antigen or antibody to hepatitis C virus at Screening;
- The subject has a known history of infection with the human immunodeficiency virus (HIV); -
- The subject has used bisphosphonate or fluoride therapy within the past 12 or 24 months, respectively;
- The subject has used denosumab within the past 24 months;
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 |
|---|---|---|
| 2 POMx Capsules2 POMx Capsules daily | Dietary supplement | 2 POMx Capsules |
| 2 placebo Capsules2 placebo Capsules daily | Dietary supplement | 2 placebo Capsules |
Primary outcome
Biomarkers
Time frame: Throughout study
To evaluate the impact of pomegranate extract capsules on urinary N-terminal telopeptide (NTX) and serum procollagen type 1 amino-terminal propeptide (P1NP), in post-menopausal women with decreased bone mineral density
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Throughout study
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 13 Oct 2010.
Related trials for Osteopenic Women
Recruiting
Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women
Low Back Pain, Osteopenia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 2 POMx Capsules in people with Osteopenic Women, run by POM Wonderful LLC 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 4 inclusion and 14 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 13 Oct 2010. 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 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?
Biomarkers (time frame: Throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2010.