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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00471237




Registration number
NCT00471237
Ethics application status
Date submitted
7/05/2007
Date registered
9/05/2007
Date last updated
7/11/2017

Titles & IDs
Public title
A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.
Scientific 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
Secondary ID [1] 0 0
CR9108963
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ronacaleret
Treatment: Drugs - Teriparatide
Treatment: Drugs - Alendronate

No Intervention: Placebo - 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

Active Comparator: Alendronate - 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

Active Comparator: Teriparatide - 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

Experimental: Ronacaleret - 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.


Treatment: Drugs: Ronacaleret
100mg, 200mg, 300mg, 400mg

Treatment: Drugs: Teriparatide
PTH (1-34)

Treatment: Drugs: Alendronate
Bisphosphonate

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (Day 0) and 12 Months
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to Month 12
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to Month 12
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to Month 12
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
Up to 12 Months
Primary outcome [6] 0 0
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.
Timepoint [6] 0 0
Up to 12 months
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline (Day 0), Month 6, 12 and early withdrawal
Primary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline (Day 0), Month 6, 12 and early withdrawal
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (Day 0) and Month 6
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (Day 0), Month 6 and Month 12
Secondary outcome [3] 0 0
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%.
Timepoint [3] 0 0
Baseline (Day 0), Month 5, 6 and 12
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline (Day 0) and Month 12
Secondary outcome [5] 0 0
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%.
Timepoint [5] 0 0
Baseline (Day 0) and Month 12
Secondary outcome [6] 0 0
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%.
Timepoint [6] 0 0
Baseline (Day 0) and Month 12
Secondary outcome [7] 0 0
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%.
Timepoint [7] 0 0
Baseline (Day 0) and Month 12
Secondary outcome [8] 0 0
Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide a1 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.
Timepoint [8] 0 0
Baseline (Day 0), Week 4, Month 3, 6, and 12
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline (Day 0), Week 4, Month 3, 6, and 12
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Baseline (Day 0), Week 4, Month 3, 6, and 12
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
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-t) of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
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
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
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

Eligibility
Key inclusion criteria
Inclusion:

- 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.
Minimum age
18 Years
Maximum age
79 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:

- 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).

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [2] 0 0
GSK Investigational Site - Footscray
Recruitment hospital [3] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [4] 0 0
GSK Investigational Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Ciudad Autonoma de Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Ciudad Autónoma de Buenos Aires
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Liege
Country [12] 0 0
Belgium
State/province [12] 0 0
Tienen
Country [13] 0 0
Denmark
State/province [13] 0 0
Ballerup
Country [14] 0 0
Germany
State/province [14] 0 0
Hessen
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Hong Kong
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Shatin
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Suwon
Country [21] 0 0
Mexico
State/province [21] 0 0
Mexico, D.F.
Country [22] 0 0
Norway
State/province [22] 0 0
Bergen
Country [23] 0 0
Norway
State/province [23] 0 0
Hamar
Country [24] 0 0
Norway
State/province [24] 0 0
Oslo
Country [25] 0 0
Poland
State/province [25] 0 0
Grudziadz
Country [26] 0 0
Poland
State/province [26] 0 0
Warszawa
Country [27] 0 0
Poland
State/province [27] 0 0
Wroclaw
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Moscow
Country [29] 0 0
South Africa
State/province [29] 0 0
Panorama
Country [30] 0 0
South Africa
State/province [30] 0 0
Rosebank
Country [31] 0 0
South Africa
State/province [31] 0 0
Somerset West
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Santiago de Compostela

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00471237
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00471237