OsteoporosisPhase 2NCT00471237

A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.

A Phase 2 study testing Ronacaleret, Teriparatide and Alendronate in people with Osteoporosis, run by GlaxoSmithKline at 49 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in the treatment of osteoporosis in post-menopausal women, in comparison with 2 active comparators and placebo. Read more about this study

Who is it for?: Ages 18 to 79 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: Ronacaleret, Teriparatide and Alendronate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 564 participants
Where: 49 sitesin 14 countries
Study dates: 14 May 2007to 26 Dec 2008
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 18 to 79 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent: Subject is willing and able to provide written informed consent.
Menopausal status: Ambulatory female aged < 80 years at screening and >5 years postmenopausal.
T-Score: A subject with either no or only one prevalent vertebral fracture is eligible for inclusion if she satisfies one of the following T-score requirements:
If no prevalent vertebral fracture subject must have an absolute BMD value consistent with a T-score of less than or equal to -2.5 and greater than -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine, or If one prevalent vertebral fracture subject must have an absolute BMD value consistent with a T-score of less than or equal to -2.0 and greater than -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine.
Suitable vertebra: Two or more vertebra in the range of L1 to L4 that are suitable for BMD measurement by DXA.
Protocol compliance: Subject who, in the opinion of the investigator, is willing and able to comply with the requirements of the protocol.

Who cannot join

T-Score: Has an absolute BMD value consistent with a T-score less than or equal to -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine.
Vertebral fractures: Has >1 prevalent vertebral fracture at the screening visit.
Non-vertebral fractures: Any previous non-vertebral osteoporosis related/fragility fracture after age 40.
Spine deformity: Significant spine deformity which would preclude DXA/QCT assessments.
BMI: BMI ≥33kg/m2.
Bone metabolic diseases: Other than osteoporosis, history or concurrent diseases affecting bone metabolism (e.g., osteomalacia, hyperparathyroidism, hyperthyroidism).

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GI disease: History of major upper gastrointestinal disease
Malabsorption: Active or history of malabsorption (e.g., history of celiac disease, irritable bowel syndrome or inflammatory bowel disease).
Liver disease: Past or current history of liver disease or known hepatic or biliary abnormalities, (with the exception of previously documented diagnosis of Gilbert's syndrome).
Rheumatoid arthritis: Active disease or history of rheumatoid arthritis.
Nephrolithiasis: History of or active nephrolithiasis (kidney stones).
Osteosarcoma risk: Subjects at increased risk of osteosarcoma such as those with Paget's disease of bone or any prior external beam or implant radiation therapy involving the skeleton.
Malignancy: Malignant disease diagnosed within the previous 5 years (except resected basal cell cancer).
Biological abnormalities: Any clinically relevant biological abnormality found and/or volunteered at screening (other than those related to the disease under investigation) which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study.
Surgical and medical conditions: Presence of the following conditions within six months prior to screening: myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, cardiac arrhythmia, clinically evident congestive heart failure, or cerebrovascular accident.
Glomerular filtration rate: Glomerular filtration rate (GFR) <35 mL/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation as follows: GFR (mL/min/1.73 m2) = 186 x (Serum creatinine mg/dL)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African American) (conventional units).
QT/QTc prolongation: A marked baseline prolongation of QT/QTc interval (e.g., QTc interval ≥450 msec on the Screening ECG).
Torsades de Pointes: A history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
Liver chemistries: Liver chemistries [aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin] exceeding 2-fold the upper limit of the laboratory-specified reference range, at screening.
Abnormal serum calcium: Serum calcium (total or albumin-adjusted) outside the central laboratory reference range at the screening visit.
Abnormal PTH: PTH (intact or whole) outside the normal range.
Abnormal creatine phosphokinase: Creatine phosphokinase (CPK) outside the normal range.
Abnormal alkaline phosphatase: Alkaline phosphatase outside of the normal range.
Thyroid hormone replacement: Subjects receiving thyroid hormone replacement therapy must have a TSH level checked. Subjects will be excluded if TSH levels are <0.1 or >10.0mIU/L. However, subjects will not be excluded if TSH is in the range 0.1-4.5 mIU/L. If TSH is >4.5 and ≤10.0mIU/mL, measure T4 and exclude the subject only if the T4 is outside the normal range.
Vitamin D deficiency: Vitamin D deficiency (serum 25-hydroxy vitamin D < 20ng/mL, equivalent to 50nmol/L) at screening. Subjects can undergo vitamin D repletion as per local practice and be re-screened once only for vitamin D levels within the 6-week screening period. They will remain excluded if the re-screened value is < 20ng/mL.
Previous strontium or IV bisphosphonate: Any previous treatment with strontium ranelate or intravenous bisphosphonate.
Oral bisphosphonates: Any previous treatment with an oral bisphosphonate as follows:
any treatment within the last six months
one month cumulative treatment within the last 12 months
three months cumulative treatment within the past two years, or
two years cumulative treatment within the past five years.
Fluoride: Treatment with fluoride (dose greater than 10mg/day) within the previous 5 years for osteoporosis.
Digoxin: Current therapy with digoxin.
Bone metabolism drugs: Treatment with other drugs affecting bone metabolism within the last six months prior to screening:
Chronic systemic corticosteroid [e.g., glucocorticoid, mineralocorticoid] treatment of no more than 2 intra-articular injections within the past year or use of oral, parenteral, or long-term, high-dose inhaled corticosteroids. Treatment with any topical corticosteroid will not exclude the subject from participating.
Hormones [e.g., estrogens/"natural estrogen preparations"(except for nonsystemic vaginal treatment), 19-norprogestins, SERMs such as raloxifene, anabolic steroids/androgens such as dehydroepiandrosterone (DHEA) or its sulfated form (DHEAS), nandrolone, tibolone, active vitamin D analogs/metabolites such as 1,25-dihydroxy vitamin D (calcitriol) or 1alpha-hydroxyvitamin D3 (1-alpha hydroxycholecalciferol), calcitonin].
Calcineurin inhibitors [e.g., cyclosporine, tacrolimus] or methotrexate.
Previous anabolic agents: Treatment with PTH, PTH analogues or similar anabolic agent for osteoporosis within the last two years.
Contraindications: Contraindications to therapy with calcium or vitamin D.
Pregnancy: Women who are pregnant are not allowed in this study.
Interfering medications: Vitamin A in excess of 10,000 IU per day, heparin, or lithium, or anticonvulsant medications except benzodiazepines.
Investigational drug exposure: Administration of any investigational drug within 90 days preceding the first dose of the study drug.
Substance abuse: History or current evidence of drug or alcohol abuse within the previous 12 months.
Problems swallowing: Inability to swallow a tablet whole.
The following exclusion criteria do not apply to subjects allocated to the open-label teriparatide group:
Calcium channel blockers: Current therapy with calcium channel blockers diltiazem and verapamil.
Oral Azole Antifungals: Current therapy with any oral azole antifungal.
Immunosuppressants: Current therapy with cyclosporine or oral tacrolimus.
Ritonavir: Current therapy with ritonavir.
Quinidine: Current therapy with quinidine.
Macrolide Antibiotics: Subjects anticipated to require chronic use of macrolide antibiotics.
Alendronate Contraindications: Contraindications to therapy with alendronate. Additional Exclusion Criteria for Subjects Recruited at QCT Sites
Hip surgery: History of hip surgery resulting in a metal implant on either the left or right side that would cause an artefact on a QCT scan.
Additional Exclusion Criteria for Teriparatide Subjects
Teriparatide contraindications: Contraindications to therapy with teriparatide according to locally approved datasheet.

Trial locations and contacts

49 sites in 14 countries.

Country

City, postcode or hospital

49 sites in 14 countries

United States9 sites

GSK Investigational Site
Akron, Ohio, 44313
GSK Investigational Site
Bethesda, Maryland, 20817
GSK Investigational Site
Cleveland, Ohio, 44195
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
Duncansville, Pennsylvania, 16635
GSK Investigational Site
Oakland, California, 94609
GSK Investigational Site
Palm Desert, California, 92260
GSK Investigational Site
Portland, Oregon, 97213
GSK Investigational Site
Walnut Creek, California, 94598

Other trials in United States

Germany7 sites

GSK Investigational Site
Berlin, 10559
GSK Investigational Site
Berlin, 12203
GSK Investigational Site
Berlin, 12247
GSK Investigational Site
Berlin, 13125
GSK Investigational Site
Frankfurt am Main, Hesse, 60528
GSK Investigational Site
Hamburg, 22143
GSK Investigational Site
Hamburg, 22415

Other trials in Germany

Spain6 sites

GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Madrid, 28007
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Santiago de Compostela, 15705
GSK Investigational Site
Santiago de Compostela, 15706

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Australia4 sites

GSK Investigational Site
Footscray, Victoria, 3011
GSK Investigational Site
Geelong, Victoria, 3220
GSK Investigational Site
Heidelberg, Victoria, 3081
GSK Investigational Site
St Leonards, New South Wales, 2065

Other trials in Australia

Argentina3 sites

GSK Investigational Site
Buenos Aires, 1012
GSK Investigational Site
Buenos Aires, C1128AAF
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1117ABH

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Belgium3 sites

GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Liège, 4020
GSK Investigational Site
Tienen, 3300

Other trials in Belgium

Norway3 sites

GSK Investigational Site
Bergen, 5094
GSK Investigational Site
Hamar, 2317
GSK Investigational Site
Oslo, 0176

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Poland3 sites

GSK Investigational Site
Grudziądz, 86-300
GSK Investigational Site
Warsaw, 02-341
GSK Investigational Site
Wroclaw, 50-088

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South Africa3 sites

GSK Investigational Site
Panorama, 7500
GSK Investigational Site
Rosebank, 2196
GSK Investigational Site
Somerset West, 7130

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Hong Kong2 sites

GSK Investigational Site
Hong Kong
GSK Investigational Site
Shatin

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Russia2 sites

GSK Investigational Site
Moscow, 117292
GSK Investigational Site
Moscow, 127299

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South Korea2 sites

GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Suwon, 443-721

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Denmark1 site

GSK Investigational Site
Ballerup Municipality, 2750

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Mexico1 site

GSK Investigational Site
Mexico City, 14050

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About this study

Official title: Study CR9108963: A 12-month, Randomized, Double-blind, Parallel-group, Placebo and Active-controlled Dose-range Finding Study of the Efficacy and Safety of SB-751689 in Post-menopausal Women With Osteoporosis

This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in the treatment of osteoporosis in post-menopausal women, in comparison with 2 active comparators and placebo.

Conditions: Osteoporosis
Being tested: Ronacaleret, Teriparatide, Alendronate
Keywords: bone mineral density,, Ronacaleret, teriparatide, alendronate,, Post-menopausal women,, osteoporosis,, SB-751689
Medical subject headings: Osteoporosis

What participants receive

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

RonacaleretDrug
Also called SB-751689
100mg, 200mg, 300mg, 400mg
TeriparatideDrug
PTH (1-34)
AlendronateDrug
Bisphosphonate

Study groups in NCT00471237
Study group	Role	What they receive
Placebo	No intervention	All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study
Alendronate	Active comparator	All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study Receives: Drug: Alendronate
Teriparatide	Active comparator	Open-label arm. All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study Receives: Drug: Teriparatide
Ronacaleret	Experimental	4 arms, 100mg, 200mg, 300mg, 400mg. All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study. Receives: Drug: Ronacaleret

What is being measured

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

Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)
DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline in areal bone mineral density (aBMD) was reported.
Measured: Baseline (Day 0) and 12 Months
Number of Participants With Hypercalcemia
Participants with albumin-adjusted serum calcium pre-dose values of >11.0 mg/ deciliter (dL) or post-dose values of >12.0 mg/dL were recorded as participants with hypercalcemia. Number of participant with hypercalcemia were reported.
Measured: Up to Month 12
Number of Participants Withdrew Due to Hypercalcemia
A confirmed albumin-adjusted serum calcium pre-dose value of >11.0 mg/dL or post-dose value of >12.0 mg/dL was set as a withdrawal criteria for the study. Number of participants who met this pre-defined stopping criteria were reported.
Measured: Up to Month 12
Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit
The hematology parameters analyzed were white blood cells (WBC) count with differential WBC count, red blood cells, haemoglobin, haematocrit, mean corpuscular volume and platelet count. The clinical chemistry parameters analyzed were sodium, potassium, calcium, calcium (albumin adjusted), phosphate, bicarbonate, creatinine, bilirubin (total), alanine amino transferase, aspartate amino transferase, glucose, albumin, alkaline phosphatase, creatine phosphokinase, urea, uric acid, total protein, 25-OH vitamin D, 1,25-2(OH) vitamin D, whole parathyroid hormone (PTH 1-84)) and intact PTH (1-84 and 7-84). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important laboratory findings at any visit were reported.
Measured: Up to Month 12
Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit
The potential clinical importance ranges (low and high) of the vital sign parameters-systolic blood pressure (> 30 millimeter of mercury [mmHg] decrease from Baseline, > 30 mmHg increase from Baseline), diastolic blood pressure (> 20 mmHg decrease from Baseline and > 20 mmHg increase from Baseline) and heart rate (<45 and >120 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.
Measured: Up to 12 Months
Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event
Full 12-lead ECGs pre-dose at screening and visits 6, 8, 11, 12 and 14 were recorded. Participants rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. The central reviewer measured the following parameters and provide a clinical interpretation: heart rate, RR interval, PR interval, QRS interval, QT (uncorrected) interval, QTcB (Bazett's correction) interval, QTcF (Fridericia's correction) interval. The central reviewer was provided the investigator or designated qualified site physician with a central ECG report or confirmatory report to assist them in identifying any clinically significant abnormalities that would preclude the participant from further participation in the study.
Measured: Up to 12 months
Mean Change From Baseline in Height
Assessments performed on Day 0 were considered as Baseline. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in height at Month 6 and 12 and early withdrawal were reported.
Measured: Baseline (Day 0), Month 6, 12 and early withdrawal
Mean Change From Baseline in Weight
Baseline values were assessed on Day 0. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in weight at Month 6, 12 and early withdrawal were reported.
Measured: Baseline (Day 0), Month 6, 12 and early withdrawal

Secondary outcomes (14)

Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)
DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from baseline to month 6 in aBMD was reported.
Measured: Baseline (Day 0) and Month 6
Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).
DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from baseline to month 6 and 12 in aBMD of hip (total hip, femoral neck and trochanter) were reported.
Measured: Baseline (Day 0), Month 6 and Month 12
Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)
Responder rate of participants who remained the same or had any improvement as compared to baseline in DXA BMD of vertebra, femur and vertebra plus femur were reported. Baseline values were assessed on Day 0. Percent change (improvement) from Baseline was computed as (change from baseline / baseline value) * 100%.
Measured: Baseline (Day 0), Month 5, 6 and 12
Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans
QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular volume of interest (VOI) are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline to month 12 in the volumetric integral, cortical, and trabecular density (BMD) at the hip and lumbar spine measured by QCT were reported.
Measured: Baseline (Day 0) and Month 12
Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans
QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.
Measured: Baseline (Day 0) and Month 12
Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans
QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in mg/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.
Measured: Baseline (Day 0) and Month 12
Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans
Percent change in thickness of femur neck cortical VOI thickness and trochanter cortical VOI thickness were at Month 12 measured by QCT were reported. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.
Measured: Baseline (Day 0) and Month 12
Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)
Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of CTX1.
Measured: Baseline (Day 0), Week 4, Month 3, 6, and 12
Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)
Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of P1NP.
Measured: Baseline (Day 0), Week 4, Month 3, 6, and 12
Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)
Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of BALP.
Measured: Baseline (Day 0), Week 4, Month 3, 6, and 12
Blood Concentrations of Ronacaleret
Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Blood concentrations of ronacaleret were reported.
Measured: Pre-dose (0.0 hour [h]) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12
Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret
Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, AUC(0-t) and AUC(0-τ) of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.
Measured: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12
Maximum Blood Concentration (Cmax) of Ronacaleret
Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, Cmax of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.
Measured: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12
Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)
Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods.
Measured: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12

Timeline

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

14 May 200726 Dec 2008

First posted9 May 2007 (estimated)
Study start14 May 2007
Primary completion26 Dec 2008
Study completion26 Dec 2008

Why it stopped: Terminated for futility by sponsor after a pre-planned interim review of data

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 564 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00471237
Sponsor's protocol ID: CR9108963
Status last verified: Sep 2017
First submitted: 7 May 2007
Last updated: 7 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Fitzpatrick LA, Dabrowski CE, Cicconetti G, Gordon DN, Fuerst T, Engelke K, Genant HK. Ronacaleret, a calcium-sensing receptor antagonist, increases trabecular but not cortical bone in postmenopausal women. J Bone Miner Res. 2012 Feb;27(2):255-62. doi: 10.1002/jbmr.554.
PubMed 22052452
Fitzpatrick LA, Dabrowski CE, Cicconetti G, Gordon DN, Papapoulos S, Bone HG 3rd, Bilezikian JP. The effects of ronacaleret, a calcium-sensing receptor antagonist, on bone mineral density and biochemical markers of bone turnover in postmenopausal women with low bone mineral density. J Clin Endocrinol Metab. 2011 Aug;96(8):2441-9. doi: 10.1210/jc.2010-2855. Epub 2011 May 18.
PubMed 21593114

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 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study CR9108963: A 12-month, Randomized, Double-blind, Parallel-group, Placebo and Active-controlled Dose-range Finding Study of the Efficacy and Safety of SB-751689 in Post-menopausal Women With Osteoporosis
ClinicalTrials.gov ID: NCT00471237
Acronym / sponsor ID: CR9108963
Conditions: Osteoporosis
Keywords: bone mineral density,, Ronacaleret, teriparatide, alendronate,, Post-menopausal women,, osteoporosis,, SB-751689
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated for futility by sponsor after a pre-planned interim review of data
Enrolment: 564 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 May 2007 (actual)
Primary completion: 26 Dec 2008 (actual)
Study completion: 26 Dec 2008 (actual)
First posted: 9 May 2007 (estimated)
Results: Posted 5 Sep 2017

Clinical summary

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

This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in the treatment of osteoporosis in post-menopausal women, in comparison with 2 active comparators and placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	No intervention	–All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study
Alendronate	Active comparator	Drug: AlendronateAll subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study
Teriparatide	Active comparator	Drug: TeriparatideOpen-label arm. All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study
Ronacaleret	Experimental	Drug: Ronacaleret4 arms, 100mg, 200mg, 300mg, 400mg. All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study.

Who may qualify

Ages: 18 to 79 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Informed consent: Subject is willing and able to provide written informed consent.
Menopausal status: Ambulatory female aged < 80 years at screening and >5 years postmenopausal.
T-Score: A subject with either no or only one prevalent vertebral fracture is eligible for inclusion if she satisfies one of the following T-score requirements:
If no prevalent vertebral fracture subject must have an absolute BMD value consistent with a T-score of less than or equal to -2.5 and greater than -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine, or If one prevalent vertebral fracture subject must have an absolute BMD value consistent with a T-score of less than or equal to -2.0 and greater than -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine.
Suitable vertebra: Two or more vertebra in the range of L1 to L4 that are suitable for BMD measurement by DXA.

Key exclusion criteria (55 listed)

T-Score: Has an absolute BMD value consistent with a T-score less than or equal to -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine.
Vertebral fractures: Has >1 prevalent vertebral fracture at the screening visit.
Non-vertebral fractures: Any previous non-vertebral osteoporosis related/fragility fracture after age 40.
Spine deformity: Significant spine deformity which would preclude DXA/QCT assessments.
BMI: BMI ≥33kg/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
RonacaleretAlso: SB-751689100mg, 200mg, 300mg, 400mg	Drug	Ronacaleret
TeriparatidePTH (1-34)	Drug	Teriparatide
AlendronateBisphosphonate	Drug	Alendronate

Primary outcome

Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)
Time frame: Baseline (Day 0) and 12 Months
DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline in areal bone mineral density (aBMD) was reported.
Number of Participants With Hypercalcemia
Time frame: Up to Month 12
Participants with albumin-adjusted serum calcium pre-dose values of >11.0 mg/ deciliter (dL) or post-dose values of >12.0 mg/dL were recorded as participants with hypercalcemia. Number of participant with hypercalcemia were reported.
Number of Participants Withdrew Due to Hypercalcemia
Time frame: Up to Month 12
A confirmed albumin-adjusted serum calcium pre-dose value of >11.0 mg/dL or post-dose value of >12.0 mg/dL was set as a withdrawal criteria for the study. Number of participants who met this pre-defined stopping criteria were reported.
Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit
Time frame: Up to Month 12
The hematology parameters analyzed were white blood cells (WBC) count with differential WBC count, red blood cells, haemoglobin, haematocrit, mean corpuscular volume and platelet count. The clinical chemistry parameters analyzed were sodium, potassium, calcium, calcium (albumin adjusted), phosphate, bicarbonate, creatinine, bilirubin (total), alanine amino transferase, aspartate amino transferase, glucose, albumin, alkaline phosphatase, creatine phosphokinase, urea, uric acid, total protein, 25-OH vitamin D, 1,25-2(OH) vitamin D, whole parathyroid hormone (PTH 1-84)) and intact PTH (1-84 and 7-84). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important laboratory findings at any visit were reported.
Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit
Time frame: Up to 12 Months
The potential clinical importance ranges (low and high) of the vital sign parameters-systolic blood pressure (> 30 millimeter of mercury [mmHg] decrease from Baseline, > 30 mmHg increase from Baseline), diastolic blood pressure (> 20 mmHg decrease from Baseline and > 20 mmHg increase from Baseline) and heart rate (<45 and >120 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.
Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event
Time frame: Up to 12 months
Full 12-lead ECGs pre-dose at screening and visits 6, 8, 11, 12 and 14 were recorded. Participants rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. The central reviewer measured the following parameters and provide a clinical interpretation: heart rate, RR interval, PR interval, QRS interval, QT (uncorrected) interval, QTcB (Bazett's correction) interval, QTcF (Fridericia's correction) interval. The central reviewer was provided the investigator or designated qualified site physician with a central ECG report or confirmatory report to assist them in identifying any clinically significant abnormalities that would preclude the participant from further participation in the study.
Mean Change From Baseline in Height
Time frame: Baseline (Day 0), Month 6, 12 and early withdrawal
Assessments performed on Day 0 were considered as Baseline. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in height at Month 6 and 12 and early withdrawal were reported.
Mean Change From Baseline in Weight
Time frame: Baseline (Day 0), Month 6, 12 and early withdrawal
Baseline values were assessed on Day 0. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in weight at Month 6, 12 and early withdrawal were reported.

14 secondary outcomes

Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)
Time frame: Baseline (Day 0) and Month 6
Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).
Time frame: Baseline (Day 0), Month 6 and Month 12
Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)
Time frame: Baseline (Day 0), Month 5, 6 and 12
Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans
Time frame: Baseline (Day 0) and Month 12
Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans
Time frame: Baseline (Day 0) and Month 12
Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans
Time frame: Baseline (Day 0) and Month 12
Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans
Time frame: Baseline (Day 0) and Month 12
Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)
Time frame: Baseline (Day 0), Week 4, Month 3, 6, and 12
Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)
Time frame: Baseline (Day 0), Week 4, Month 3, 6, and 12
Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)
Time frame: Baseline (Day 0), Week 4, Month 3, 6, and 12
Blood Concentrations of Ronacaleret
Time frame: Pre-dose (0.0 hour [h]) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12
Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret
Time frame: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12
Maximum Blood Concentration (Cmax) of Ronacaleret
Time frame: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12
Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)
Time frame: Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12

Results and safety

Results posted to the registry on 5 Sep 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
Placebo	90	49
Ronacaleret, 100 mg Tablet, OD	87	45
Ronacaleret, 200 mg Tablet, OD	82	48
Ronacaleret, 300 mg Tablet, OD	88	43
Ronacaleret, 400 mg Tablet, OD	87	46
Alendronate, 70 mg, Capsule, OW	89	50
Teriparatide, 20 mcg, SC Injection, OD	41	38

Primary outcome: Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)

Time frame: Baseline (Day 0) and 12 Months. Least squares mean (Standard Error). Unit: Percent change in BMD

Measure	Placebo n = 79	Ronacaleret, 100 mg Tablet, OD n = 76	Ronacaleret, 200 mg Tablet, OD n = 74	Ronacaleret, 300 mg Tablet, OD n = 78	Ronacaleret, 400 mg Tablet, OD n = 72	Alendronate, 70 mg, Capsule, OW n = 75
Value	0.03 (0.38)	0.32 (0.40)	1.39 (0.40)	1.61 (0.39)	1.62 (0.40)	4.54 (0.40)

Placebo vs Ronacaleret, 100 mg Tablet, OD: Mean Difference (Net): 0.29 (95% CI -0.78 to 1.37), p = 0.590, ANOVA
Placebo vs Ronacaleret, 200 mg Tablet, OD: Mean Difference (Net): 1.36 (95% CI 0.28 to 2.44), p = 0.028, ANOVA
Placebo vs Ronacaleret, 300 mg Tablet, OD: Mean Difference (Net): 1.58 (95% CI 0.51 to 2.65), p = 0.011, ANOVA

Population analysed: Intent-to-Treat population comprised of any randomised or teriparatide participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed. Teriparatide arm was excluded from the analysis, since these participants were not randomized and were disproportionately represented.

Primary outcome: Number of Participants With Hypercalcemia

Time frame: Up to Month 12. Count of participants. Unit: Participants

Measure	Placebo n = 90	Ronacaleret, 100 mg Tablet, OD n = 87	Ronacaleret, 200 mg Tablet, OD n = 82	Ronacaleret, 300 mg Tablet, OD n = 88	Ronacaleret, 400 mg Tablet, OD n = 87	Alendronate, 70 mg, Capsule, OW n = 89	Teriparatide, 20 mcg, SC Injection, OD n = 41
Value	0	1	1	4	11	0	1

Population analysed: Intent-to-Treat population.

Primary outcome: Number of Participants Withdrew Due to Hypercalcemia

Time frame: Up to Month 12. Count of participants. Unit: Participants

Measure	Placebo n = 90	Ronacaleret, 100 mg Tablet, OD n = 87	Ronacaleret, 200 mg Tablet, OD n = 82	Ronacaleret, 300 mg Tablet, OD n = 88	Ronacaleret, 400 mg Tablet, OD n = 87	Alendronate, 70 mg, Capsule, OW n = 89	Teriparatide, 20 mcg, SC Injection, OD n = 41
Value	0	0	0	0	0	0	0

Population analysed: Intent-to-Treat population.

Primary outcome: Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit

Time frame: Up to Month 12. Count of participants. Unit: Participants

Measure	Placebo n = 90	Ronacaleret, 100 mg Tablet, OD n = 87	Ronacaleret, 200 mg Tablet, OD n = 82	Ronacaleret, 300 mg Tablet, OD n = 88	Ronacaleret, 400 mg Tablet, OD n = 87	Alendronate, 70 mg, Capsule, OW n = 89	Teriparatide, 20 mcg, SC Injection, OD n = 41
Monocytes- high	17	14	19	17	18	28	6
Total neutrophils- high	9	11	10	10	4	6	4
Total neutrophils- low	16	5	8	8	14	13	4
Eosinophils- high	12	8	11	18	19	11	6
Glucose- high	10	6	9	5	4	5	3
Glucose- low	3	0	4	0	3	0	0
Basophils- high	2	0	1	0	1	1	0
Hematocrit- low	2	0	0	2	0	0	1

Population analysed: Intent-to-Treat population.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Follow-up visit (12 month and 2 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 90 (0%)	54 of 90 (60%)	0 of 90
Ronacaleret, 100 mg Tablet, OD	2 of 87 (2.3%)	54 of 87 (62.1%)	0 of 87
Ronacaleret, 200 mg Tablet, OD	5 of 82 (6.1%)	57 of 82 (69.5%)	0 of 82
Ronacaleret, 300 mg Tablet, OD	7 of 88 (8%)	55 of 88 (62.5%)	0 of 88
Ronacaleret, 400 mg Tablet, OD	3 of 87 (3.4%)	61 of 87 (70.1%)	0 of 87
Alendronate, 70 mg, Capsule, OW	6 of 89 (6.7%)	46 of 89 (51.7%)	0 of 89
Teriparatide, 20 mcg, SC Injection, OD	4 of 41 (9.8%)	30 of 41 (73.2%)	0 of 41

Limitations and caveats (from the sponsor): The study was terminated for futility in a phased manner by the sponsor on 25-Sep-2008 once the results of a planned 6-month interim analysis were available.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22052452Fitzpatrick LA, Dabrowski CE, Cicconetti G, Gordon DN, Fuerst T, Engelke K, Genant HK. Ronacaleret, a calcium-sensing receptor antagonist, increases trabecular but not cortical bone in postmenopausal women. J Bone Miner Res. 2012 Feb;27(2):255-62. doi: 10.1002/jbmr.554.
Derived from this study: PubMed 21593114Fitzpatrick LA, Dabrowski CE, Cicconetti G, Gordon DN, Papapoulos S, Bone HG 3rd, Bilezikian JP. The effects of ronacaleret, a calcium-sensing receptor antagonist, on bone mineral density and biochemical markers of bone turnover in postmenopausal women with low bone mineral density. J Clin Endocrinol Metab. 2011 Aug;96(8):2441-9. doi: 10.1210/jc.2010-2855. Epub 2011 May 18.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

49 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ronacaleret, Teriparatide and Alendronate in people with Osteoporosis, run by GlaxoSmithKline at 49 sites in 14 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 6 inclusion and 55 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: stopped early, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Germany, Spain, Australia, Argentina and 9 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 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 5 Sep 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?

Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4) (time frame: Baseline (Day 0) and 12 Months). The study lists 8 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 NCT00471237, which also lists 2 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 Nov 2017.