Breast CancerPhase 2WISENCT00090857

Letrozole in Preventing Breast Cancer in Postmenopausal Women

A Phase 2 study testing Letrozole in people with Breast Cancer, run by Dana-Farber Cancer Institute at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol… Read more about this study

Who is it for?: Ages 35 to 120 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: Letrozole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 5 sitesUnited States
Study dates: Feb 2002to Mar 2013
Phase: Phase 2
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 35 to 120 years
Women only
No healthy volunteers
Adult, Older adult

DISEASE CHARACTERISTICS:

At increased risk for the development or recurrence of breast cancer, defined as an estradiol level ≥ 9 pg/mL
No evidence of suspicious or malignant disease, based on the following examinations:
Clinical bilateral breast examination within the past 6 months
Bilateral* mammogram within 3 months before randomization OR within 30 days after randomization
Pelvic exam normal within the past 5 years
General physical exam within the past 6 months NOTE: *Unilateral mammogram of the uninvolved breast for patients with prior invasive breast cancer or ductal carcinoma in situ (DCIS)
Bone density scan within 2 standard deviations from normal within the past 30 days
Bone density scan ≥ 2 standard deviations below normal allowed if approved by the study physician
At least 1 breast that has not been previously treated with radiotherapy or surgery (for patients with prior invasive breast cancer or DCIS)
Hormone receptor status:
Not specified

PATIENT CHARACTERISTICS:

Age

35 and over

Sex

Female

Menopausal status

Postmenopausal, defined by any of the following criteria:
At least 12 months without spontaneous menstrual bleeding
Prior hysterectomy and bilateral salpingo-oophorectomy
≥ 55 years of age with a prior hysterectomy with or without oophorectomy
< 55 years of age with a prior hysterectomy without oophorectomy OR the status of the ovaries is unknown AND follicle-stimulating hormone (FSH) level is in the postmenopausal range

Performance status

Normal activity must not be restricted for a significant portion of the day

Life expectancy

At least 10 years

Hematopoietic

Complete blood count with differential normal
Prior benign neutropenia allowed provided the granulocyte count is ≥ 1,500/mm^3

Hepatic

Bilirubin normal
Alkaline phosphatase normal
SGOT and SGPT normal

Renal

Creatinine normal

Cardiovascular

No uncontrolled cardiovascular disease

Other

Not pregnant
No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No osteoporosis
No hyperlipidemia
No mental health status resulting in cognitive or emotional impairment that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

More than 30 days since prior AND no concurrent use of any of the following hormonal agents:
Estrogen or progesterone replacement therapy
Oral contraceptives
Raloxifene or other plasma estrogen receptor modulators (SERMs)
Androgens (e.g., danazol)
Luteinizing hormone-releasing hormone (LHRH) analogs (e.g., goserelin or leuprolide)
Prolactin inhibitors (e.g., bromocriptine)
Antiandrogens (e.g., cyproterone)
More than 60 days since prior AND no concurrent tamoxifen
No prior aromatase inhibitors (for patients with prior invasive breast cancer or DCIS)
No concurrent phytoestrogenic dietary supplements (e.g., soy, ginseng, or other natural products)
Dietary soy allowed

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics
No prior bilateral mastectomy

Other

More than 60 days since prior treatment for invasive breast cancer or DCIS
More than 30 days since prior bisphosphonates or calcitonin
No prior or concurrent participation on a treatment study for invasive breast cancer or DCIS
No concurrent participation in any other cancer prevention study or osteoporosis prevention study involving pharmacologic agents
No concurrent calcitonin
No concurrent bisphosphonate therapy
Concurrent cholecalciferol (vitamin D) and calcium to augment bone mineral density allowed

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, 77030
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283

Other trials in United States

About this study

Official title: A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels

PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.

Read the detailed description

OBJECTIVES:

Primary

The primary outcome of the study is the change in bone mineral density following a year on letrozole vs. a year on placebo.

Secondary

Compare the safety, acceptability, and adherence to letrozole vs placebo in postmenopausal women at increased risk for the development or recurrence of breast cancer based on elevated plasma estradiol levels through evaluation of menopausal symptoms (including hot flushes, weight changes, sexual functioning, and genitourinary effects), blood lipid levels, markers of bone turnover, and multidimensional quality of life.
Determine the effect of letrozole-induced reduction of plasma estradiol levels on mammographic percent breast density.
Obtain background information for a future large chemoprevention trial to address the question of whether a reduction in plasma estradiol levels can reduce the risk of breast cancer in postmenopausal women.

OUTLINE: This is a pilot, randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 2:1 (experimental treatment: placebo arms).

PROJECTED ACCRUAL: A total of 110 patients (73 for arm I and 37 for arm II) will be accrued for this study.

Conditions: Breast Cancer
Being tested: Letrozole, Placebo
Keywords: breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, breast cancer in situ, ductal breast carcinoma in situ
Medical subject headings: Breast Neoplasms, Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LetrozoleDrug
Also called Femara
PlaceboOther

Study groups in NCT00090857
Study group	Role	What they receive
Letrozole	Experimental	Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer. Receives: Drug: Letrozole
Placebo	Placebo comparator	Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Lumbar Density From Baseline to 12 Months
The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Measured: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
Change in Femoral Neck Density From Baseline to 12 Months
The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Measured: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
Change in Trochanter Density From Baseline to 12 Months
The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Measured: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
Change in Hip Density From Baseline to 12 Months
The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Measured: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.

Secondary outcomes (8)

Worst Grade Hot Flashes
Participants reported worst grade hot flashes: 01: mild (<1qd) or 02: moderate (>1qd) during 12 months of treatment.
Measured: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Muscle Aches/Pains
Participants reported worst grade muscle aches/pains defined as grade 01: mild, 02: moderate, 03: severe (CTCAEv3) or 04: disabling (CTCAEv3) during 12 months of treatment.
Measured: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Nausea
Participants reported worst grade nausea grade 01: able to eat, 02: oral intake significantly decreased, 03: no significant intake, requiring IV fluids during 12 months of treatment.
Measured: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Vomiting
Participants reported worst grade vomiting grade 01: 1x in 24 hours, 02: 2-5x in 24 hours, 03: >/= 6x in 24 hours, grade 04: requiring parenteral nutrition/intensive care during 12 months of treatment.
Measured: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Abdominal Pain
Participants reported worst grade abdominal pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Measured: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Bone Pain
Participants reported worst grade bone pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Measured: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Headache
Participants reported worst grade headache: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Measured: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Fatigue
Participants reported worst grade fatigue: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.
Measured: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2002Mar 2013

First posted8 Sep 2004 (estimated)
Study startFeb 2002
Primary completionAug 2008
Study completionMar 2013

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 Breast CancerStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00090857
Sponsor's protocol ID: DFCI-00024
Other IDs: P50CA089393, P30CA006516, DFCI-00024, UCLA-0210012-02
Acronym: WISE
Status last verified: Mar 2018
First submitted: 7 Sep 2004
Last updated: 30 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels
ClinicalTrials.gov ID: NCT00090857
Acronym / sponsor ID: WISE / DFCI-00024
Conditions: Breast Cancer
Keywords: breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, breast cancer in situ
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Jonsson Comprehensive Cancer Center
Study start: Feb 2002 (actual)
Primary completion: Aug 2008 (actual)
Study completion: Mar 2013 (actual)
First posted: 8 Sep 2004 (estimated)
Results: Posted 29 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.

Detailed description

OBJECTIVES:

Primary

The primary outcome of the study is the change in bone mineral density following a year on letrozole vs. a year on placebo.

Secondary

Compare the safety, acceptability, and adherence to letrozole vs placebo in postmenopausal women at increased risk for the development or recurrence of breast cancer based on elevated plasma estradiol levels through evaluation of menopausal symptoms (including hot flushes, weight changes, sexual functioning, and genitourinary effects), blood lipid levels, markers of bone turnover, and multidimensional quality of life.
Determine the effect of letrozole-induced reduction of plasma estradiol levels on mammographic percent breast density.
Obtain background information for a future large chemoprevention trial to address the question of whether a reduction in plasma estradiol levels can reduce the risk of breast cancer in postmenopausal women.

OUTLINE: This is a pilot, randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 2:1 (experimental treatment: placebo arms).

PROJECTED ACCRUAL: A total of 110 patients (73 for arm I and 37 for arm II) will be accrued for this study.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Letrozole	Experimental	Drug: LetrozoleParticipants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
Placebo	Placebo comparator	Other: PlaceboParticipants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.

Who may qualify

Ages: 35 to 120 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
LetrozoleAlso: Femara	Drug	Letrozole
Placebo	Other	Placebo

Primary outcome

Change in Lumbar Density From Baseline to 12 Months
Time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Change in Femoral Neck Density From Baseline to 12 Months
Time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Change in Trochanter Density From Baseline to 12 Months
Time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.
Change in Hip Density From Baseline to 12 Months
Time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.

8 secondary outcomes

Worst Grade Hot Flashes
Time frame: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Muscle Aches/Pains
Time frame: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Nausea
Time frame: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Vomiting
Time frame: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Abdominal Pain
Time frame: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Bone Pain
Time frame: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Headache
Time frame: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.
Worst Grade Fatigue
Time frame: Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.

Results and safety

Results posted to the registry on 29 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Letrozole	33	29
Placebo	16	13

Primary outcome: Change in Lumbar Density From Baseline to 12 Months

Time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.. Median (Full Range). Unit: g/cm^2

Measure	Letrozole n = 29	Placebo n = 13
Value	-0.036 (-0.092 to 0.272)	-0.021 (-0.180 to 0.064)

Letrozole vs Placebo: p = 0.15, Wilcoxon (Mann-Whitney)

Population analysed: The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of lumbar density.

Primary outcome: Change in Femoral Neck Density From Baseline to 12 Months

Time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.. Median (Full Range). Unit: g/cm^2

Measure	Letrozole n = 28	Placebo n = 13
Value	-0.0065 (-0.097 to 0.068)	-0.013 (-0.13 to 0.029)

Letrozole vs Placebo: p = 0.70, Wilcoxon (Mann-Whitney)

Population analysed: The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of femoral neck density.

Primary outcome: Change in Trochanter Density From Baseline to 12 Months

Time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.. Median (Full Range). Unit: g/cm^2

Measure	Letrozole n = 27	Placebo n = 13
Value	-0.017 (-0.059 to 0.023)	-0.009 (-0.059 to 0.015)

Letrozole vs Placebo: p = 0.03, Wilcoxon (Mann-Whitney)

Population analysed: The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of trochanter density.

Primary outcome: Change in Hip Density From Baseline to 12 Months

Time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.. Median (Full Range). Unit: g/cm^2

Measure	Letrozole n = 28	Placebo n = 13
Value	-0.0275 (-0.082 to 0.035)	-0.001 (-0.075 to 0.025)

Letrozole vs Placebo: p = 0.06, Wilcoxon (Mann-Whitney)

Population analysed: The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of hip density.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were evaluated and reported on the case report forms while participants were on randomized treatment at each clinic follow-up visit (months 6 and 12). If participants opted to continue treatment beyond 12 months then adverse events were monitored annually. Relevant for this report were the adverse events associated with the planned 12 months of treatment. 86% of patients in this study cohort completed 12 months of randomized treatment (median treatment duration is 12 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Letrozole	1 of 33 (3%)	6 of 33 (18.2%)	0 of 33
Placebo	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16

Limitations and caveats (from the sponsor): Results on this study are limited due to the age of the trial and the prior departure of the coordinator who assisted with the data collection. The accrual goal was not met with many participants eligible upon screening declining randomization.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Judy Garber, MD principal investigator

Dana-Farber Cancer Institute

Patricia A. Ganz, MD principal investigator

Jonsson Comprehensive Cancer Center

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letrozole in people with Breast Cancer, run by Dana-Farber Cancer Institute at 5 sites 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?

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 30 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 5 sites 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 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?

Yes. Results are posted in the registry (first posted 29 Jun 2017). 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?

Change in Lumbar Density From Baseline to 12 Months (time frame: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.). The study lists 4 primary outcomes in all. 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 NCT00090857.

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 30 Mar 2018.