OsteopeniaNCT02422082
The Effect of Lactobacillus Reuteri ATCC PTA 6475 on Volumetric Bone Mineral Density in Patients With Osteopenia
A study testing L. reuteri in people with Osteopenia, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Lactobacillus reuteri (L. reuteri) has been widely studied in clinical trials and has probiotic, health-promoting effects in both adults and children, and is safe for human consumption. Animal models indicate that treatment with L. reuteri has positive effects on bone metabolism and bone density. Read more about this study
- Who is it for?
- Ages 75 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- L. reuteri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 8 May 2015to 1 Dec 2017
- 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 75 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- bone mineral density T-score less than -1 but more than -2.5 in the total hip or femoral neck or lumbar spine (L1-L4) by dual energy x-ray absorptiometry
- signed informed consent
- stated availability throughout the entire study period
- mental ability to understand and willingness to fulfill all the details of the protocol
Who cannot join
- untreated hyperthyroidism
- rheumatoid arthritis
- diagnosed with disease causing secondary osteoporosis within the last year, including primary hyperparathyroidism, chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes
- recently diagnosed malignancy (within the last 5 years)
- per oral corticosteroid use
- use of antiresorptive therapy, including systemic hormone replacement therapy, bisphosphonates, strontium ran elate
Show all 9Show fewer
- use of teriparatide (current or during the last 3 years)
- participation in other clinical interventional trials
- use of antibiotics within 2 months preceding the inclusion
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Geriatric Medicine, Mölndal Hospital
Mölndal, Västra Götaland County, 43180
About this study
Lactobacillus reuteri (L. reuteri) has been widely studied in clinical trials and has probiotic, health-promoting effects in both adults and children, and is safe for human consumption. Animal models indicate that treatment with L. reuteri has positive effects on bone metabolism and bone density. In other animal models of diabetes and the metabolic syndrome, positive effects on blood glucose and weight have been reported. The present double-blind, placebo-controlled, randomized study is designed to investigate if dietary supplementation with L. reuteri twice daily for 12 months has any effect on bone density, body composition, inflammation, or metabolic and endocrine markers in elderly women with osteopenia.
Read the detailed description
The role of the gut microbes for human health has gained considerable interest in recent years. Lactobacillus reuteri (L.reuteri) is a naturally occurring bacterial species in the human gut. L. reuteri has been widely studied in clinical trials of adults and children and treatment with L. reuteri is safe and is associated with health-promoting effects in humans. In animal models, L. reuteri has anti-inflammatory effects and in ovariectomized mice supplementation with L. reuteri partly prevented the bone loss induced by estrogen deficiency. Furthermore, both bone density and bone formation increased in male mice in another mice model. In mice with medically induced diabetes mellitus, L. reuteri reduced blood glucose and in a mouse model mimicking the metabolic syndrome, L. reuteri prevented diet-induced obesity. The present study is a double-blind, placebo-controlled, randomized, study in 90 elderly women with osteopenia recruited from the population. These women will be treated with L. reuteri or placebo orally twice daily for 12 months. The effects on bone will be investigated with dual energy x-ray absorptiometry, high-resolution peripheral quantitative computed tomography, and bone turnover markers. Hormones and markers of inflammation and metabolism will be followed as well as changes in the gut microbiota composition.
- Conditions
- Osteopenia
- Being tested
- L. reuteri, Placebo
- Keywords
- Osteopenia, Lactobacillus reuteri, Volumetric bone mineral density
- 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.
L. reuteriDietary supplement
Also called Lactobacillus reuteri ATCC PTA 6475
Dietary supplementation with L. reuteri twice daily for 12 months
PlaceboDietary supplement
Dietary supplementation with placebo twice daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri | Active comparator | Lactobacillus reuteri (L. reuteri) ATCC PTA 6475 at a dose of 5 000 000 000 CFU as a powder in a stick-pack, orally twice daily (morning and evening) yielding a total daily dose of 10 000 000 000 CFU per day, for 12 months. Receives: Dietary Supplement: L. reuteri |
| Placebo | Placebo comparator | Placebo product identical to the active product (L. reuteri) in taste and appearance but without the active component, orally twice daily, for 12 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total tibia volumetric bone mineral density
Change in percent in total tibia volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri
Measured: 12 months
Secondary outcomes (33)
Trabecular volumetric bone mineral density
Change in percent in trabecular volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri
Measured: 12 months
Cortical volumetric bone mineral density
Change in percent in cortical volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri
Measured: 12 months
Cortical thickness
Change in percent in cortical thickness compared to placebo group after 1 year of dietary supplementation with L. reuteri
Measured: 12 months
Cortical porosity
Change in percent in cortical porosity compared to placebo group after 1 year of dietary supplementation with L. reuteri
Measured: 12 months
Areal bone mineral density
Change in percent in areal bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri
Measured: 12 months
Bone material strength index
Change in percent in bone material strength index compared to placebo group after 1 year of dietary supplementation with L. reuteri
Measured: 12 months
Blood pressure
Change in percent in blood pressure compared to placebo group after 1 year of dietary supplementation with L. reuteri
Measured: 12 months
Change in gut microbiota composition
Change in percent in gut microbiota composition compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Ultrasensitive C-reactive protein
Change in percent in ultrasensitive C-reactive protein in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Interleukin-10
Change in percent in interleukin-10 in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Interleukin-17
Change in percent in interleukin-17 in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Tumor-necrosis factor-alpha
Change in percent in tumor-necrosis factor-alpha in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Tartrate-resistent alkaline phosphatase 5b
Change in percent in tartrate-resistent alkaline phosphatase 5b in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Cross-linked N-terminal telopeptide
Change in percent in cross-linked N-terminal telopeptide in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Bone-specific alkaline phosphatase
Change in percent in bone-specific alkaline phosphatase in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Receptor activator of nuclear factor kappa B (RANK)
Change in percent in RANK in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Receptor activator of nuclear factor kappa B ligand (RANK-ligand)
Change in percent in RANK-ligand in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Osteocalcin
Change in percent in osteocalcin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Blood glucose
Change in percent in blood glucose compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Haemoglobin A1C
Change in percent in haemoglobin A1C compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Apolipoprotein A1 (ApoA1)
Change in percent in ApoA1 compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Apolipoprotein B (ApoB)
Change in percent in ApoB compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Cholesterol
Change in percent in cholesterol compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
High density lipoprotein (HDL)
Change in percent in HDL compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Low density lipoprotein (LDL)
Change in percent in LDL compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Triglycerides
Change in percent in triglycerides compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Oxytocin
Change in percent in oxytocin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Estradiol
Change in percent in estradiol in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Leptin
Change in percent in leptin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Adiponectin
Change in percent in adiponectin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Testosterone
Change in percent in testosterone in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri
Measured: 3-12 months
Lean mass
Change in percent in lean mass compared to placebo after 12 months of dietary supplementation with L. reuteri
Measured: 12 months
Fat mass
Change in percent in fat mass compared to placebo after 12 months of dietary supplementation with L. reuteri
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start8 May 2015
- Primary completion15 Sep 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Mattias Lorentzon, Sahlgrenska University Hospital
- Investigators
- Mattias Lorentzon, MD, PhD, Principal investigator, Dept Geriatrics, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422082
- Sponsor's protocol ID
- LRvBMD
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2015
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams MR, Marteau P. On the safety of lactic acid bacteria from food. Int J Food Microbiol. 1995 Oct;27(2-3):263-4. doi: 10.1016/0168-1605(95)00067-t. No abstract available.
PubMed 8579995Reid G, Kim SO, Kohler GA. Selecting, testing and understanding probiotic microorganisms. FEMS Immunol Med Microbiol. 2006 Mar;46(2):149-57. doi: 10.1111/j.1574-695X.2005.00026.x.
PubMed 16487295Britton RA, Irwin R, Quach D, Schaefer L, Zhang J, Lee T, Parameswaran N, McCabe LR. Probiotic L. reuteri treatment prevents bone loss in a menopausal ovariectomized mouse model. J Cell Physiol. 2014 Nov;229(11):1822-30. doi: 10.1002/jcp.24636.
PubMed 24677054McCabe LR, Irwin R, Schaefer L, Britton RA. Probiotic use decreases intestinal inflammation and increases bone density in healthy male but not female mice. J Cell Physiol. 2013 Aug;228(8):1793-8. doi: 10.1002/jcp.24340.
PubMed 23389860Fak F, Backhed F. Lactobacillus reuteri prevents diet-induced obesity, but not atherosclerosis, in a strain dependent fashion in Apoe-/- mice. PLoS One. 2012;7(10):e46837. doi: 10.1371/journal.pone.0046837. Epub 2012 Oct 9.
PubMed 23056479
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactobacillus Reuteri ATCC PTA 6475 on Volumetric Bone Mineral Density in Patients With Osteopenia
- ClinicalTrials.gov ID
- NCT02422082
- Acronym / sponsor ID
- LRvBMD
- Conditions
- Osteopenia
- Keywords
- Osteopenia, Lactobacillus reuteri, Volumetric bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- 8 May 2015 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 21 Apr 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.
Lactobacillus reuteri (L. reuteri) has been widely studied in clinical trials and has probiotic, health-promoting effects in both adults and children, and is safe for human consumption. Animal models indicate that treatment with L. reuteri has positive effects on bone metabolism and bone density. In other animal models of diabetes and the metabolic syndrome, positive effects on blood glucose and weight have been reported. The present double-blind, placebo-controlled, randomized study is designed to investigate if dietary supplementation with L. reuteri twice daily for 12 months has any effect on bone density, body composition, inflammation, or metabolic and endocrine markers in elderly women with osteopenia.
Detailed description
The role of the gut microbes for human health has gained considerable interest in recent years. Lactobacillus reuteri (L.reuteri) is a naturally occurring bacterial species in the human gut. L. reuteri has been widely studied in clinical trials of adults and children and treatment with L. reuteri is safe and is associated with health-promoting effects in humans. In animal models, L. reuteri has anti-inflammatory effects and in ovariectomized mice supplementation with L. reuteri partly prevented the bone loss induced by estrogen deficiency. Furthermore, both bone density and bone formation increased in male mice in another mice model. In mice with medically induced diabetes mellitus, L. reuteri reduced blood glucose and in a mouse model mimicking the metabolic syndrome, L. reuteri prevented diet-induced obesity. The present study is a double-blind, placebo-controlled, randomized, study in 90 elderly women with osteopenia recruited from the population. These women will be treated with L. reuteri or placebo orally twice daily for 12 months. The effects on bone will be investigated with dual energy x-ray absorptiometry, high-resolution peripheral quantitative computed tomography, and bone turnover markers. Hormones and markers of inflammation and metabolism will be followed as well as changes in the gut microbiota composition.
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 |
|---|---|---|
| L. reuteri | Active comparator | Dietary Supplement: L. reuteriLactobacillus reuteri (L. reuteri) ATCC PTA 6475 at a dose of 5 000 000 000 CFU as a powder in a stick-pack, orally twice daily (morning and evening) yielding a total daily dose of 10 000 000 000 CFU per day, for 12 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo product identical to the active product (L. reuteri) in taste and appearance but without the active component, orally twice daily, for 12 months. |
Who may qualify
- Ages
- 75 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- bone mineral density T-score less than -1 but more than -2.5 in the total hip or femoral neck or lumbar spine (L1-L4) by dual energy x-ray absorptiometry
- signed informed consent
- stated availability throughout the entire study period
- mental ability to understand and willingness to fulfill all the details of the protocol
Key exclusion criteria (9 listed)
- untreated hyperthyroidism
- rheumatoid arthritis
- diagnosed with disease causing secondary osteoporosis within the last year, including primary hyperparathyroidism, chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes
- recently diagnosed malignancy (within the last 5 years)
- per oral corticosteroid use
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 |
|---|---|---|
| L. reuteriAlso: Lactobacillus reuteri ATCC PTA 6475Dietary supplementation with L. reuteri twice daily for 12 months | Dietary supplement | L. reuteri |
| PlaceboDietary supplementation with placebo twice daily for 12 months | Dietary supplement | Placebo |
Primary outcome
Total tibia volumetric bone mineral density
Time frame: 12 months
Change in percent in total tibia volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri
33 secondary outcomes
Trabecular volumetric bone mineral density
Time frame: 12 months
Cortical volumetric bone mineral density
Time frame: 12 months
Cortical thickness
Time frame: 12 months
Cortical porosity
Time frame: 12 months
Areal bone mineral density
Time frame: 12 months
Bone material strength index
Time frame: 12 months
Blood pressure
Time frame: 12 months
Change in gut microbiota composition
Time frame: 3-12 months
Ultrasensitive C-reactive protein
Time frame: 3-12 months
Interleukin-10
Time frame: 3-12 months
Interleukin-17
Time frame: 3-12 months
Tumor-necrosis factor-alpha
Time frame: 3-12 months
Tartrate-resistent alkaline phosphatase 5b
Time frame: 3-12 months
Cross-linked N-terminal telopeptide
Time frame: 3-12 months
Bone-specific alkaline phosphatase
Time frame: 3-12 months
Receptor activator of nuclear factor kappa B (RANK)
Time frame: 3-12 months
Receptor activator of nuclear factor kappa B ligand (RANK-ligand)
Time frame: 3-12 months
Osteocalcin
Time frame: 3-12 months
Blood glucose
Time frame: 3-12 months
Haemoglobin A1C
Time frame: 3-12 months
Apolipoprotein A1 (ApoA1)
Time frame: 3-12 months
Apolipoprotein B (ApoB)
Time frame: 3-12 months
Cholesterol
Time frame: 3-12 months
High density lipoprotein (HDL)
Time frame: 3-12 months
Low density lipoprotein (LDL)
Time frame: 3-12 months
Triglycerides
Time frame: 3-12 months
Oxytocin
Time frame: 3-12 months
Estradiol
Time frame: 3-12 months
Leptin
Time frame: 3-12 months
Adiponectin
Time frame: 3-12 months
Testosterone
Time frame: 3-12 months
Lean mass
Time frame: 12 months
Fat mass
Time frame: 12 months
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 18 Apr 2018.
- Background: PubMed 8579995Adams MR, Marteau P. On the safety of lactic acid bacteria from food. Int J Food Microbiol. 1995 Oct;27(2-3):263-4. doi: 10.1016/0168-1605(95)00067-t. No abstract available.
- Background: PubMed 16487295Reid G, Kim SO, Kohler GA. Selecting, testing and understanding probiotic microorganisms. FEMS Immunol Med Microbiol. 2006 Mar;46(2):149-57. doi: 10.1111/j.1574-695X.2005.00026.x.
- Background: PubMed 24677054Britton RA, Irwin R, Quach D, Schaefer L, Zhang J, Lee T, Parameswaran N, McCabe LR. Probiotic L. reuteri treatment prevents bone loss in a menopausal ovariectomized mouse model. J Cell Physiol. 2014 Nov;229(11):1822-30. doi: 10.1002/jcp.24636.
- Background: PubMed 23389860McCabe LR, Irwin R, Schaefer L, Britton RA. Probiotic use decreases intestinal inflammation and increases bone density in healthy male but not female mice. J Cell Physiol. 2013 Aug;228(8):1793-8. doi: 10.1002/jcp.24340.
- Background: PubMed 23056479Fak F, Backhed F. Lactobacillus reuteri prevents diet-induced obesity, but not atherosclerosis, in a strain dependent fashion in Apoe-/- mice. PLoS One. 2012;7(10):e46837. doi: 10.1371/journal.pone.0046837. Epub 2012 Oct 9.
- Individual participant dataSharing planned: No
Related trials for Osteopenia
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
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.
Mattias Lorentzon, MD, PhD principal investigator
Dept Geriatrics, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. reuteri in people with Osteopenia, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 9 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 18 Apr 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 Sweden. 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?
Total tibia volumetric bone mineral density (time frame: 12 months). 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 NCT02422082, which also lists 5 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 18 Apr 2018.