Post Menopausal OsteoporosisPhase 3NCT00048061
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
A Phase 3 study testing Ibandronate [Bonviva/Boniva], Calcium and Vitamin D in people with Post Menopausal Osteoporosis, run by Hoffmann-La Roche at 68 sites in 19 countries.
Trial summary
This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Post Menopausal Osteoporosis
- What is being tested?
- Ibandronate [Bonviva/Boniva], Calcium and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,609 participants
- Where
- 68 sitesin 19 countries
- Study dates
- Apr 2002to Dec 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women 55-80 years of age;
- post-menopausal for >= 5 years;
- ambulatory.
Who cannot join
- malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
- breast cancer within the previous 20 years;
- allergy to bisphosphonates;
- previous treatment with an intravenous bisphosphonate at any time;
- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.
Trial locations and contacts
68 sites in 19 countries.
68 sites in 19 countries
United States20 sites
Study site
Albuquerque, New Mexico, 87106
Study site
Bethesda, Maryland, 20817
Study site
Billings, Montana, 59120
Study site
Gainesville, Florida, 32607
Study site
Irvine, California, 92618
Study site
Lakewood, Colorado, 80227
Study site
Livingston, New Jersey, 07039
Study site
Loma Linda, California, 92357
Study site
Los Angeles, California, 90211
Study site
Madison, Wisconsin, 53792
Study site
Oakland, California, 94612
Study site
Omaha, Nebraska, 68131
Study site
Portland, Oregon, 97213
Study site
Rancho Mirage, California, 92270
Study site
Richmond, Virginia, 23294
Study site
San Antonio, Texas, 78229
Study site
Seattle, Washington, 98144
Study site
St Louis, Missouri, 63110
Study site
Wheaton, Maryland, 20902
Study site
Wyomissing, Pennsylvania, 19610
Hungary5 sites
Study site
Balatonfüred, 8230
Study site
Budapest, 1036
Study site
Budapest, 1083
Study site
Kiskunhalas, 6400
Study site
Zalaegerszeg, 8900
Australia4 sites
Study site
Adelaide, 5000
Study site
Adelaide, 5035
Study site
Parkville, 3052
Study site
Perth, 6979
Brazil4 sites
Study site
Campinas, 13077-005
Study site
Curitiba, 80060-240
Study site
Porto Alegre, 90035-003
Study site
São Paulo, 04026-000
Canada4 sites
Study site
Calgary, Alberta, T2N 4N1
Study site
Québec, Quebec, G1V 3M7
Study site
Toronto, Ontario, M5S 1B2
Study site
Vancouver, British Columbia, V5Z 2N6
United Kingdom4 sites
Study site
Cardiff, CF64 2XX
Study site
Liverpool, L22 0LG
Study site
London, E11 1NR
Study site
Southampton, SO16 6YD
Czechia3 sites
Study site
Pilsen, 305 99
Study site
Prague, 128 00
Study site
Prague, 169 02
Denmark3 sites
Study site
Aalborg, 9000
Study site
Ballerup Municipality, 2750
Study site
Vejle, 7100
Norway3 sites
Study site
Haugesund, 5507
Study site
Oslo, 0176
Study site
Stavanger, 4010
South Africa2 sites
Study site
Cape Town, 7500
Study site
Johannesburg, 2196
About this study
Official title: Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis
This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
- Conditions
- Post Menopausal Osteoporosis
- Being tested
- Ibandronate [Bonviva/Boniva], Calcium, Vitamin D
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibandronate [Bonviva/Boniva]Drug
2.5mg po daily
Ibandronate [Bonviva/Boniva]Drug
100mg po monthly on a single day
Ibandronate [Bonviva/Boniva]Drug
100mg po monthly over 2 consecutive days
Ibandronate [Bonviva/Boniva]Drug
150mg po monthly
CalciumDietary supplement
500 mg/day
Vitamin DDietary supplement
400 IU/day
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate 2.5 mg | Active comparator | Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day . Receives: Drug: Ibandronate [Bonviva/Boniva]; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D |
| Ibandronate 50/50 mg | Experimental | Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day. Receives: Drug: Ibandronate [Bonviva/Boniva]; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D |
| Ibandronate 100 mg | Experimental | Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day Receives: Drug: Ibandronate [Bonviva/Boniva]; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D |
| Ibandronate 150 mg | Experimental | Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day Receives: Drug: Ibandronate [Bonviva/Boniva]; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
Measured: From Baseline (Month 0) to Month 12
Secondary outcomes (15)
Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.
Measured: From Baseline (Month 0) to Month 24
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.
Measured: From Baseline (Month 0) to Months 12 and 24
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.
Measured: From Baseline (Month 0) to Months 12 and 24
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center
Measured: From Baseline (Month 0) to Months 12 and 24
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.
Measured: Months 12 and 24
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.
Measured: Months 12 and 24
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.
Measured: Months 12 and 24
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.
Measured: Months 12 and 24
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.
Measured: Months 12 and 24
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.
Measured: Months 12 and 24
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.
Measured: Months 12 and 24
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Measured: From Baseline (Month 0) to Months 3, 6, 12, 24
Absolute Change In Baseline in Serum CTX to Months 12 and 24
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Measured: From Baseline (Month 0) to Months 12 and 24
Number of Participants With Any Adverse Events and Serious Adverse Event
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Measured: Up to Month 24
Number Of Participants With Marked Laboratory Abnormalities
Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L].
Measured: Up to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2002 (estimated)
- Study startApr 2002
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Menopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048061
- Sponsor's protocol ID
- BM16549
- Status last verified
- Feb 2018
- First submitted
- 24 Oct 2002
- Last updated
- 29 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT00048061
- Acronym / sponsor ID
- BM16549
- Conditions
- Post Menopausal Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,609 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 25 Oct 2002 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ibandronate 2.5 mg | Active comparator | Drug: Ibandronate [Bonviva/Boniva], Dietary Supplement: Calcium, Dietary Supplement: Vitamin DParticipants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day . |
| Ibandronate 50/50 mg | Experimental | Drug: Ibandronate [Bonviva/Boniva], Dietary Supplement: Calcium, Dietary Supplement: Vitamin DParticipants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day. |
| Ibandronate 100 mg | Experimental | Drug: Ibandronate [Bonviva/Boniva], Dietary Supplement: Calcium, Dietary Supplement: Vitamin DParticipants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day |
| Ibandronate 150 mg | Experimental | Drug: Ibandronate [Bonviva/Boniva], Dietary Supplement: Calcium, Dietary Supplement: Vitamin DParticipants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women 55-80 years of age;
- post-menopausal for >= 5 years;
- ambulatory.
Key exclusion criteria (5 listed)
- malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
- breast cancer within the previous 20 years;
- allergy to bisphosphonates;
- previous treatment with an intravenous bisphosphonate at any time;
- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.
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 |
|---|---|---|
| Ibandronate [Bonviva/Boniva]2.5mg po daily | Drug | Ibandronate 2.5 mg |
| Ibandronate [Bonviva/Boniva]100mg po monthly on a single day | Drug | Ibandronate 50/50 mg |
| Ibandronate [Bonviva/Boniva]100mg po monthly over 2 consecutive days | Drug | Ibandronate 100 mg |
| Ibandronate [Bonviva/Boniva]150mg po monthly | Drug | Ibandronate 150 mg |
| Calcium500 mg/day | Dietary supplement | Ibandronate 100 mg, Ibandronate 150 mg, Ibandronate 2.5 mg, Ibandronate 50/50 mg |
| Vitamin D400 IU/day | Dietary supplement | Ibandronate 100 mg, Ibandronate 150 mg, Ibandronate 2.5 mg, Ibandronate 50/50 mg |
Primary outcome
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
Time frame: From Baseline (Month 0) to Month 12
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
15 secondary outcomes
Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Time frame: From Baseline (Month 0) to Month 24
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Time frame: From Baseline (Month 0) to Months 12 and 24
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Time frame: From Baseline (Month 0) to Months 12 and 24
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Time frame: From Baseline (Month 0) to Months 12 and 24
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
Time frame: Months 12 and 24
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
Time frame: Months 12 and 24
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
Time frame: Months 12 and 24
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
Time frame: Months 12 and 24
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Time frame: Months 12 and 24
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Time frame: Months 12 and 24
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Time frame: Months 12 and 24
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
Time frame: From Baseline (Month 0) to Months 3, 6, 12, 24
Absolute Change In Baseline in Serum CTX to Months 12 and 24
Time frame: From Baseline (Month 0) to Months 12 and 24
Number of Participants With Any Adverse Events and Serious Adverse Event
Time frame: Up to Month 24
Number Of Participants With Marked Laboratory Abnormalities
Time frame: Up to Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
68 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibandronate [Bonviva/Boniva], Calcium and Vitamin D in people with Post Menopausal Osteoporosis, run by Hoffmann-La Roche at 68 sites in 19 countries.
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 3 inclusion and 5 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Hungary, Australia, Brazil, Canada and 14 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (time frame: From Baseline (Month 0) to Month 12). 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 29 Mar 2018.