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Terminated for futility by sponsor after a pre-planned interim review of data
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ronacaleret | Drug | 100mg, 200mg, 300mg, 400mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion:
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.
Exclusion:
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.
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.
The following exclusion criteria do not apply to subjects allocated to the open-label teriparatide group:
Additional Exclusion Criteria for Teriparatide Subjects
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Oakland | California | 94609 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22052452 | Background | 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. | |
| 21593114 | Derived | 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. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| CR9108963 | Statistical Analysis Plan | View IPD |
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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Of the 1609 participants screened, 1040 were screen failures, remaining 569 were randomized to the treatment arms. One participant from each of the 4 ronacaleret groups and alendronate group were excluded from Intent-to-Treat population and 564 participants were included in Intent-to-Treat population.
The study was conducted between 14-May-2007and 26-December-2008 at 45 centres in 14 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo once daily (OD) (matching to ronacaleret tablet) and matching placebo once weekly (OW) (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 milligrams (mg) and vitamin D, at least 400 international units (IU), OD in the evening as dietary supplements throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Teriparatide | Drug | PTH (1-34) |
|
| Alendronate | Drug | Bisphosphonate |
|
| 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. | 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. | 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. | 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. | Baseline (Day 0), Month 6, 12 and early withdrawal |
| 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. | 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%. | 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. | 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%. | 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%. | 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%. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 |
| Palm Desert |
| California |
| 92260 |
| United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Bethesda | Maryland | 20817 | United States |
| GSK Investigational Site | Akron | Ohio | 44313 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44195 | United States |
| GSK Investigational Site | Portland | Oregon | 97213 | United States |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1117ABH | Argentina |
| GSK Investigational Site | Buenos Aires | 1012 | Argentina |
| GSK Investigational Site | Buenos Aires | C1128AAF | Argentina |
| GSK Investigational Site | St Leonards | New South Wales | 2065 | Australia |
| GSK Investigational Site | Footscray | Victoria | 3011 | Australia |
| GSK Investigational Site | Geelong | Victoria | 3220 | Australia |
| GSK Investigational Site | Heidelberg | Victoria | 3081 | Australia |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Liège | 4020 | Belgium |
| GSK Investigational Site | Tienen | 3300 | Belgium |
| GSK Investigational Site | Ballerup Municipality | 2750 | Denmark |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60528 | Germany |
| GSK Investigational Site | Berlin | 10559 | Germany |
| GSK Investigational Site | Berlin | 12203 | Germany |
| GSK Investigational Site | Berlin | 12247 | Germany |
| GSK Investigational Site | Berlin | 13125 | Germany |
| GSK Investigational Site | Hamburg | 22143 | Germany |
| GSK Investigational Site | Hamburg | 22415 | Germany |
| GSK Investigational Site | Hong Kong | Hong Kong |
| GSK Investigational Site | Shatin | Hong Kong |
| GSK Investigational Site | Mexico City | 14050 | Mexico |
| GSK Investigational Site | Bergen | 5094 | Norway |
| GSK Investigational Site | Hamar | 2317 | Norway |
| GSK Investigational Site | Oslo | 0176 | Norway |
| GSK Investigational Site | Grudziądz | 86-300 | Poland |
| GSK Investigational Site | Warsaw | 02-341 | Poland |
| GSK Investigational Site | Wroclaw | 50-088 | Poland |
| GSK Investigational Site | Moscow | 117292 | Russia |
| GSK Investigational Site | Moscow | 127299 | Russia |
| GSK Investigational Site | Panorama | 7500 | South Africa |
| GSK Investigational Site | Rosebank | 2196 | South Africa |
| GSK Investigational Site | Somerset West | 7130 | South Africa |
| GSK Investigational Site | Seoul | 120-752 | South Korea |
| GSK Investigational Site | Suwon | 443-721 | South Korea |
| GSK Investigational Site | Barcelona | 08003 | Spain |
| GSK Investigational Site | Barcelona | 08022 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15705 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
For additional information about this study please refer to the GSK Clinical Study Register |
| CR9108963 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| CR9108963 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| CR9108963 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| CR9108963 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| CR9108963 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| CR9108963 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Ronacaleret, 100 mg Tablet, OD | Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| FG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| FG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| FG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| FG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| FG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 microgram (mcg), subcutaneous (SC) injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| BG001 | Ronacaleret, 100 mg Tablet, OD | Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| BG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| BG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| BG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| BG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| BG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participant |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | Percent change in BMD | Baseline (Day 0) and 12 Months |
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| Primary | 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. | Intent-to-Treat population. | Posted | Count of Participants | Participants | Up to Month 12 |
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| Primary | 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. | Intent-to-Treat population. | Posted | Count of Participants | Participants | Up to Month 12 |
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| Primary | 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. | Intent-to-Treat population. | Posted | Count of Participants | Participants | Up to Month 12 |
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| Primary | 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. | Intent-to-Treat population. | Posted | Count of Participants | Participants | Up to 12 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Intent-to-Treat population. | Posted | Count of Participants | Participants | Up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Centimeter | Baseline (Day 0), Month 6, 12 and early withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Kilogram | Baseline (Day 0), Month 6, 12 and early withdrawal |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent to Treat Population. Only those participants available at the specified time point were analyzed. Participants from Teriparatide, 20 mcg, SC injection, OD arm were excluded from the analysis, since these participants were not randomized and were disproportionately represented. | Posted | Least Squares Mean | Standard Error | percent change in BMD | Baseline (Day 0) and Month 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. Participants from Teriparatide, 20 mcg, SC injection, OD arm were excluded from the analysis, since these participants were not randomized and were disproportionately represented. | Posted | Least Squares Mean | Standard Error | Percent change in BMD | Baseline (Day 0), Month 6 and Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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%. | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day 0), Month 5, 6 and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change in BMD | Baseline (Day 0) and Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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%. | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change in VOI | Baseline (Day 0) and Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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%. | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change in BMD | Baseline (Day 0) and Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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%. | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change in cortical thickness | Baseline (Day 0) and Month 12 |
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| Secondary | 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. | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | nanogram per litre (ng/L) | Baseline (Day 0), Week 4, Month 3, 6, and 12 |
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| Secondary | 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. | Intent to treat population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Microgram per Litre (mcg/L) | Baseline (Day 0), Week 4, Month 3, 6, and 12 |
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| Secondary | 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. | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | mcg/L | Baseline (Day 0), Week 4, Month 3, 6, and 12 |
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| Secondary | 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. | Pharmacokinetic Concentration Population comprised of any Intent-to-Treat participants for whom a SB-751689 pharmacokinetic blood sample was obtained and analyzed. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | nanograms per millilitre (ng/mL) | 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 | 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. | Pharmacokinetic Parameters Population comprised of any participant in the pharmacokinetic concentration population who provided pharmacokinetic parameters. Only those participants available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per millilitre (ng*hr/mL) | 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 |
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| Secondary | 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. | Pharmacokinetic parameter population. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
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| Secondary | 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. | Pharmacokinetic parameters population. Only those participants available at the specified time points were analyzed. | Posted | Median | Full Range | h | 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 |
|
Up to Follow-up visit (12 month and 2 weeks)
Intent-to-Treat population was used to report AEs
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. | 0 | 90 | 0 | 90 | 54 | 90 |
| EG001 | Ronacaleret, 100 mg Tablet, OD | Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. | 0 | 87 | 2 | 87 | 54 | 87 |
| EG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. | 0 | 82 | 5 | 82 | 57 | 82 |
| EG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. | 0 | 88 | 7 | 88 | 55 | 88 |
| EG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. | 0 | 87 | 3 | 87 | 61 | 87 |
| EG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. | 0 | 89 | 6 | 89 | 46 | 89 |
| EG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. | 0 | 41 | 4 | 41 | 30 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Hyperplasia | General disorders | MedDRA | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Smear cervix abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Salpingo-oophorectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C561716 | ronacaleret |
| D019379 | Teriparatide |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Asian |
|
| White |
|
| African American/African Heritage & White |
|
| ANOVA |
Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.044 at Month 12 |
| 0.028 |
| Mean Difference (Net) |
| 1.36 |
| Standard Error of the Mean |
| 0.55 |
| 2-Sided |
| 95 |
| 0.28 |
| 2.44 |
| Superiority |
| ANOVA | Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.044 at Month 12. | 0.011 | Mean Difference (Net) | 1.58 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | 0.51 | 2.65 | Superiority |
| ANOVA | Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.044 at Month 12. | 0.012 | Mean Difference (Net) | 1.60 | Standard Error of the Mean | 0.55 | 2-Sided | 95 | 0.51 | 2.69 | Superiority |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
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|
Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
| OG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
|
Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG002 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG003 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG004 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG005 | Alendronate, 70 mg, Capsule, OW | Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG006 | Teriparatide, 20 mcg, SC Injection, OD | Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG002 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG001 | Ronacaleret, 200 mg Tablet, OD | Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG002 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
| OG002 | Ronacaleret, 300 mg Tablet, OD | Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
|
|
Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
| OG003 | Ronacaleret, 400 mg Tablet, OD | Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study. |
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