Osteoporosis, PostmenopausalPhase 1/2NCT02630797
Effect of Blueberries on Bone Turnover
A Phase 1/2 study testing Blueberry Baseline, Blueberry Low and Blueberry Medium in people with Osteoporosis, Postmenopausal and Bone Loss, Age-related, run by Purdue University at 1 site in United States.
Trial summary
This study uses a bone labeling calcium tracer methodology to compare the dose-response effect of blueberry consumption on calcium retention and bone loss. Post-menopausal women will receive food or beverage products containing freeze-dried blueberries in the amount equivalent to 0.75 (low), 1.5 (medium), and 3 cups… Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal, Bone Loss, Age-related
- What is being tested?
- Blueberry Baseline, Blueberry Low and Blueberry Medium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2017to Aug 2019
- Phase
- Phase 1/2
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subject is healthy
- Subject is > 4 years past the onset of natural menopause or total hysterectomy
Who cannot join
- History of metabolic bone disease or low trauma fractures;
- Subject taking osteoporosis treatment drugs or glucocorticoids within 6 months of the beginning of the study;
- Subjects taking bisphosphonates within 2 years of the beginning of the study;
- History of cancer, thromboembolisms, clotting disorders, uncontrolled hypertension, abnormal thyroid function, malabsorption syndrome, seizure disorders, or heart attack;
- BMI > 35 kg/m2;
- Subjects who will not comply with study interventions ;
- Subjects who will not stop taking natural product supplements of their own selection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Nutrition Science Purdue University
West Lafayette, Indiana, 47907-2059
About this study
Official title: Berries and Bones: The Effect of Polyphenolic Metabolites From Blueberries on Bone Turnover
This study uses a bone labeling calcium tracer methodology to compare the dose-response effect of blueberry consumption on calcium retention and bone loss. Post-menopausal women will receive food or beverage products containing freeze-dried blueberries in the amount equivalent to 0.75 (low), 1.5 (medium), and 3 cups (high) of fresh blueberries per day over a 42-day period. The hypothesis is that the polyphenolics found in blueberries will reduce calcium loss from bones.
Read the detailed description
Participants will be dosed with Ca-41, a rare long-lived radioisotope of calcium. After the equilibration of tracer in the body and its deposition in bones (150 days), subjects will be randomized to one of 6 dose sequences, all of which will begin with a 42-day baseline period. During baseline, 24-hour urine will be collected every 14 days. Following baseline, subjects will enter a 42-day intervention period with one of three doses of blueberries equivalent to 0.75 (low), 1.5 (medium), and 3 cups (high) of blueberries per day. Each dose will be provided in the form of freeze-dried blueberry powder incorporated in 2-4 foods or beverages per day. During the intervention, 24-hour urine will be collected weekly for 6 weeks except week 1. After intervention, subjects will enter a 42-day washout period, during which 24-hour urine will be collected every 3 weeks. The entire study duration will be 444 days for subjects who have not been dosed with Ca-41 previously. In a crossover design, all subjects will complete three 42-day intervention periods corresponding to the three doses of blueberries (low, medium, and high), each followed by a 42-day washout period. The dose-response effect of continuous blueberry consumption over a 42-day period on bone resorption in healthy post-menopausal women will be studied by measuring the loss of Ca-41 in urine by Accelerator Mass Spectrometry.
- Being tested
- Blueberry Baseline, Blueberry Low, Blueberry Medium, Blueberry High
- Keywords
- Bone Health, Calcium, Osteoporosis, Polyphenolics
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry BaselineDietary supplement
Before the study beginning, eligible participants will receive a radioactive tracer, Ca-41, by iv infusion. A total of 150 days will be required for the equilibration of tracer in the body i.e. elimination from soft tissue and deposition in the bone. After equilibration, a baseline period of 42 days will occur, during which no blueberry products will be provided.
Blueberry LowDietary supplement
One food or beverage product containing freeze-dried blueberry powder equivalent to 0.75 cups of fresh blueberries will be provided daily for 42 days.
Blueberry MediumDietary supplement
Two food or beverage products containing freeze-dried blueberry powder equivalent to 1.5 cups of fresh blueberries will be provided daily for 42 days.
Blueberry HighDietary supplement
Four food or beverage products containing freeze-dried blueberry powder equivalent to 3 cups of fresh blueberries will be provided daily for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry baseline | Placebo comparator | No blueberry products provided as part of the usual dietary intake Receives: Dietary Supplement: Blueberry Baseline |
| Blueberry Low | Active comparator | One blueberry product per day containing an equivalent of 0.75 cups of fresh blueberries provided as part of usual dietary intake for 42 days Receives: Dietary Supplement: Blueberry Low |
| Blueberry Medium | Active comparator | Two blueberry products per day containing an equivalent of 1.5 cups of fresh blueberries provided as part of usual dietary intake for 42 days Receives: Dietary Supplement: Blueberry Medium |
| Blueberry High | Active comparator | Four blueberry products per day containing an equivalent of 3 cups of fresh blueberries provided as part of usual dietary intake for 42 days Receives: Dietary Supplement: Blueberry High |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ca-41 / Ca ratio in 24-hour urinary excretion to estimate calcium loss from bone
Urinary Ca-41 excretion will be expressed as Ca-41/Ca ratio, which is unit-less, and converted to a percent change from the baseline value.
24-hour urine will be collected approximately every 2 weeks during baseline (week 0, 2, 4, and 6), weekly (except for week 1) during the low, medium, and high blueberry dose interventions completed in a randomized order (weeks 8-12, 20-24, 32-36) and every 3 weeks during the washout periods (weeks 15, 18, 27, 30, 39, 42). Ca-41/Ca ratios will be measured by Accelerator Mass Spectrometry.
Measured: From the beginning of baseline (week 0) to the end of the 3rd washout period (week 42)
Secondary outcomes (9)
Fasting blood and urine analysis of blueberry polyphenolic metabolites
Polyphenol concentrations in urine and serum will be expressed in molar units and compared against reference values and across the study periods. Polyphenolic metabolites will be measured by LC-MSMS.
Fasting blood and urine will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42).
Measured: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum and urine biochemical markers of bone metabolism: calcium concentration
Calcium concentration in urine and serum will be expressed in mg/L and measured by Atomic Absorption Spectrophotometry.
Fasting blood and urine will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42).
Measured: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: Insulin Dependent Growth Factor-1 (IGF-1)
IGF-1 will be expressed in ng/mL and measured by ELISA.
Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42).
Measured: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: Osteoprotegrin
Osteoprotegerin will be expressed in pmol/L and measured by ELISA.
Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42).
Measured: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: RANK ligand
RANK-L will be expressed in pmol/L and measured by ELISA.
Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42).
Measured: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: 25(OH) Vitamin D
25(OH) Vitamin D will be expressed in ng/mL and measured by LC/MS.
Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42).
Measured: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: Sclerostin
Sclerostin will be expressed in ng/mL and measured by ELISA.
Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42).
Measured: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Urine biochemical markers of bone metabolism: N-terminal telopeptide (NTX)
NTX will be expressed in ng/mL and measured by ELISA.
Fasting urine will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42).
Measured: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: procollagen I intact N-terminal (PINP)
PINP will be will be expressed in ug/L and measured by ELISA.
Fasting blood will be collected at the start and end of baseline (weeks 0 and 6), at the end of the low, medium, and high dose blueberry interventions (weeks 12, 24, and 36), and at the end of the 3 washout periods (weeks 18, 30, 42).
Measured: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start12 Jan 2017
- Primary completionJan 2019 (estimated)
- Study completionAug 2019 (estimated)
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 Osteoporosis, PostmenopausalStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This partially randomized crossover design model will include participants assigned first to a control baseline period followed by three intervention phases with a low, medium or high daily dose of blueberry products in a randomized order.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berdine Martin, Purdue University
- Investigators
- Connie M Weaver, PhD, Principal investigator, Department of Nutrition Science, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630797
- Sponsor's protocol ID
- BB2015
- Status last verified
- May 2018
- First submitted
- 7 Dec 2015
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Chen JR, Lazarenko OP, Wu X, Kang J, Blackburn ML, Shankar K, Badger TM, Ronis MJ. Dietary-induced serum phenolic acids promote bone growth via p38 MAPK/beta-catenin canonical Wnt signaling. J Bone Miner Res. 2010 Nov;25(11):2399-411. doi: 10.1002/jbmr.137.
PubMed 20499363Devareddy L, Hooshmand S, Collins JK, Lucas EA, Chai SC, Arjmandi BH. Blueberry prevents bone loss in ovariectomized rat model of postmenopausal osteoporosis. J Nutr Biochem. 2008 Oct;19(10):694-9. doi: 10.1016/j.jnutbio.2007.09.004. Epub 2008 Mar 6.
PubMed 18328688Weaver CM, Martin BR, Jackson GS, McCabe GP, Nolan JR, McCabe LD, Barnes S, Reinwald S, Boris ME, Peacock M. Antiresorptive effects of phytoestrogen supplements compared with estradiol or risedronate in postmenopausal women using (41)Ca methodology. J Clin Endocrinol Metab. 2009 Oct;94(10):3798-805. doi: 10.1210/jc.2009-0332. Epub 2009 Jul 7.
PubMed 19584189Hodges JK, Maiz M, Cao S, Lachcik PJ, Peacock M, McCabe GP, McCabe LD, Cladis DP, Jackson GS, Ferruzzi MG, Lila MA, Bailey RL, Martin BR, Weaver CM. Moderate consumption of freeze-dried blueberry powder increased net bone calcium retention compared with no treatment in healthy postmenopausal women: a randomized crossover trial. Am J Clin Nutr. 2023 Aug;118(2):382-390. doi: 10.1016/j.ajcnut.2023.05.033. Epub 2023 Jun 1.
PubMed 37269909
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berries and Bones: The Effect of Polyphenolic Metabolites From Blueberries on Bone Turnover
- ClinicalTrials.gov ID
- NCT02630797
- Acronym / sponsor ID
- BB2015
- Keywords
- Bone Health, Calcium, Osteoporosis, Polyphenolics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 15 Dec 2015 (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.
This study uses a bone labeling calcium tracer methodology to compare the dose-response effect of blueberry consumption on calcium retention and bone loss. Post-menopausal women will receive food or beverage products containing freeze-dried blueberries in the amount equivalent to 0.75 (low), 1.5 (medium), and 3 cups (high) of fresh blueberries per day over a 42-day period. The hypothesis is that the polyphenolics found in blueberries will reduce calcium loss from bones.
Detailed description
Participants will be dosed with Ca-41, a rare long-lived radioisotope of calcium. After the equilibration of tracer in the body and its deposition in bones (150 days), subjects will be randomized to one of 6 dose sequences, all of which will begin with a 42-day baseline period. During baseline, 24-hour urine will be collected every 14 days. Following baseline, subjects will enter a 42-day intervention period with one of three doses of blueberries equivalent to 0.75 (low), 1.5 (medium), and 3 cups (high) of blueberries per day. Each dose will be provided in the form of freeze-dried blueberry powder incorporated in 2-4 foods or beverages per day. During the intervention, 24-hour urine will be collected weekly for 6 weeks except week 1. After intervention, subjects will enter a 42-day washout period, during which 24-hour urine will be collected every 3 weeks. The entire study duration will be 444 days for subjects who have not been dosed with Ca-41 previously. In a crossover design, all subjects will complete three 42-day intervention periods corresponding to the three doses of blueberries (low, medium, and high), each followed by a 42-day washout period. The dose-response effect of continuous blueberry consumption over a 42-day period on bone resorption in healthy post-menopausal women will be studied by measuring the loss of Ca-41 in urine by Accelerator Mass Spectrometry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This partially randomized crossover design model will include participants assigned first to a control baseline period followed by three intervention phases with a low, medium or high daily dose of blueberry products in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Blueberry baseline | Placebo comparator | Dietary Supplement: Blueberry BaselineNo blueberry products provided as part of the usual dietary intake |
| Blueberry Low | Active comparator | Dietary Supplement: Blueberry LowOne blueberry product per day containing an equivalent of 0.75 cups of fresh blueberries provided as part of usual dietary intake for 42 days |
| Blueberry Medium | Active comparator | Dietary Supplement: Blueberry MediumTwo blueberry products per day containing an equivalent of 1.5 cups of fresh blueberries provided as part of usual dietary intake for 42 days |
| Blueberry High | Active comparator | Dietary Supplement: Blueberry HighFour blueberry products per day containing an equivalent of 3 cups of fresh blueberries provided as part of usual dietary intake for 42 days |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female subject is healthy
- Subject is > 4 years past the onset of natural menopause or total hysterectomy
Key exclusion criteria (7 listed)
- History of metabolic bone disease or low trauma fractures;
- Subject taking osteoporosis treatment drugs or glucocorticoids within 6 months of the beginning of the study;
- Subjects taking bisphosphonates within 2 years of the beginning of the study;
- History of cancer, thromboembolisms, clotting disorders, uncontrolled hypertension, abnormal thyroid function, malabsorption syndrome, seizure disorders, or heart attack;
- BMI > 35 kg/m2;
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 |
|---|---|---|
| Blueberry BaselineBefore the study beginning, eligible participants will receive a radioactive tracer, Ca-41, by iv infusion. A total of 150 days will be required for the equilibration of tracer in the body i.e. elimination from soft tissue and deposition in the bone. After equilibration, a baseline period of 42 days will occur, during which no blueberry products will be provided. | Dietary supplement | Blueberry baseline |
| Blueberry LowOne food or beverage product containing freeze-dried blueberry powder equivalent to 0.75 cups of fresh blueberries will be provided daily for 42 days. | Dietary supplement | Blueberry Low |
| Blueberry MediumTwo food or beverage products containing freeze-dried blueberry powder equivalent to 1.5 cups of fresh blueberries will be provided daily for 42 days. | Dietary supplement | Blueberry Medium |
| Blueberry HighFour food or beverage products containing freeze-dried blueberry powder equivalent to 3 cups of fresh blueberries will be provided daily for 42 days. | Dietary supplement | Blueberry High |
Primary outcome
Ca-41 / Ca ratio in 24-hour urinary excretion to estimate calcium loss from bone
Time frame: From the beginning of baseline (week 0) to the end of the 3rd washout period (week 42)
Urinary Ca-41 excretion will be expressed as Ca-41/Ca ratio, which is unit-less, and converted to a percent change from the baseline value. 24-hour urine will be collected approximately every 2 weeks during baseline (week 0, 2, 4, and 6), weekly (except for week 1) during the low, medium, and high blueberry dose interventions completed in a randomized order (weeks 8-12, 20-24, 32-36) and every 3 weeks during the washout periods (weeks 15, 18, 27, 30, 39, 42). Ca-41/Ca ratios will be measured by Accelerator Mass Spectrometry.
9 secondary outcomes
Fasting blood and urine analysis of blueberry polyphenolic metabolites
Time frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum and urine biochemical markers of bone metabolism: calcium concentration
Time frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: Insulin Dependent Growth Factor-1 (IGF-1)
Time frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: Osteoprotegrin
Time frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: RANK ligand
Time frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: 25(OH) Vitamin D
Time frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: Sclerostin
Time frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Urine biochemical markers of bone metabolism: N-terminal telopeptide (NTX)
Time frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Serum biochemical markers of bone metabolism: procollagen I intact N-terminal (PINP)
Time frame: Weeks 0, 6, 12, 18, 24, 30, 36, 42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Background: PubMed 20499363Chen JR, Lazarenko OP, Wu X, Kang J, Blackburn ML, Shankar K, Badger TM, Ronis MJ. Dietary-induced serum phenolic acids promote bone growth via p38 MAPK/beta-catenin canonical Wnt signaling. J Bone Miner Res. 2010 Nov;25(11):2399-411. doi: 10.1002/jbmr.137.
- Background: PubMed 18328688Devareddy L, Hooshmand S, Collins JK, Lucas EA, Chai SC, Arjmandi BH. Blueberry prevents bone loss in ovariectomized rat model of postmenopausal osteoporosis. J Nutr Biochem. 2008 Oct;19(10):694-9. doi: 10.1016/j.jnutbio.2007.09.004. Epub 2008 Mar 6.
- Background: PubMed 19584189Weaver CM, Martin BR, Jackson GS, McCabe GP, Nolan JR, McCabe LD, Barnes S, Reinwald S, Boris ME, Peacock M. Antiresorptive effects of phytoestrogen supplements compared with estradiol or risedronate in postmenopausal women using (41)Ca methodology. J Clin Endocrinol Metab. 2009 Oct;94(10):3798-805. doi: 10.1210/jc.2009-0332. Epub 2009 Jul 7.
- Derived from this study: PubMed 37269909Hodges JK, Maiz M, Cao S, Lachcik PJ, Peacock M, McCabe GP, McCabe LD, Cladis DP, Jackson GS, Ferruzzi MG, Lila MA, Bailey RL, Martin BR, Weaver CM. Moderate consumption of freeze-dried blueberry powder increased net bone calcium retention compared with no treatment in healthy postmenopausal women: a randomized crossover trial. Am J Clin Nutr. 2023 Aug;118(2):382-390. doi: 10.1016/j.ajcnut.2023.05.033. Epub 2023 Jun 1.
- Individual participant dataSharing planned: Undecided
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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
Department of Nutrition Science, 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 1/2 study testing Blueberry Baseline, Blueberry Low and Blueberry Medium in people with Osteoporosis, Postmenopausal and Bone Loss, Age-related, 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 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. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Ca-41 / Ca ratio in 24-hour urinary excretion to estimate calcium loss from bone (time frame: From the beginning of baseline (week 0) to the end of the 3rd washout period (week 42)). 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 NCT02630797, 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 7 May 2018; AzTrials last refreshed its copy on 1 Nov 2026.