Trial · NCT00471237
A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.
NCT00471237, Phase 2, Terminated, GlaxoSmithKline; results first posted 2017-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis. Trials, record NCT00471237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00471237
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.
- NCT number
- NCT00471237
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 564 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Osteoporosis
- Interventions
- Ronacaleret, Teriparatide, Alendronate
- First posted
- 2007-05-09
- Last updated
- 2017-11-07
- Results first posted
- 2017-09-05
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Baseline (Day 0) and 12 Months | DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%. Percent change from Baseline in areal bone mineral density (aBMD) was reported. |
| Primary | Number of Participants With Hypercalcemia | Up to Month 12 | Participants with albumin-adjusted serum calcium pre-dose values of \>11.0 mg/ deciliter (dL) or post-dose values of \>12.0 mg/dL were recorded as participants with hypercalcemia. Number of participant with hypercalcemia were reported. |
| Primary | Number of Participants Withdrew Due to Hypercalcemia | Up to Month 12 | A confirmed albumin-adjusted serum calcium pre-dose value of \>11.0 mg/dL or post-dose value of \>12.0 mg/dL was set as a withdrawal criteria for the study. Number of participants who met this pre-defined stopping criteria were reported. |
| Primary | Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit | Up to Month 12 | The hematology parameters analyzed were white blood cells (WBC) count with differential WBC count, red blood cells, haemoglobin, haematocrit, mean corpuscular volume and platelet count. The clinical chemistry parameters analyzed were sodium, potassium, calcium, calcium (albumin adjusted), phosphate, bicarbonate, creatinine, bilirubin (total), alanine amino transferase, aspartate amino transferase, glucose, albumin, alkaline phosphatase, creatine phosphokinase, urea, uric acid, total protein, 25-OH vitamin D, 1,25-2(OH) vitamin D, whole parathyroid hormone (PTH 1-84)) and intact PTH (1-84 and 7-84). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important laboratory findings at any visit were reported. |
| Primary | Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit | Up to 12 Months | The potential clinical importance ranges (low and high) of the vital sign parameters-systolic blood pressure (\> 30 millimeter of mercury \[mmHg\] decrease from Baseline, \> 30 mmHg increase from Baseline), diastolic blood pressure (\> 20 mmHg decrease from Baseline and \> 20 mmHg increase from Baseline) and heart rate (\<45 and \>120 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported. |
| Primary | Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event | Up to 12 months | Full 12-lead ECGs pre-dose at screening and visits 6, 8, 11, 12 and 14 were recorded. Participants rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. The central reviewer measured the following parameters and provide a clinical interpretation: heart rate, RR interval, PR interval, QRS interval, QT (uncorrected) interval, QTcB (Bazett's correction) interval, QTcF (Fridericia's correction) interval. The central reviewer was provided the investigator or designated qualified site physician with a central ECG report or confirmatory report to assist them in identifying any clinically significant abnormalities that would preclude the participant from further participation in the study. |
| Primary | Mean Change From Baseline in Height | Baseline (Day 0), Month 6, 12 and early withdrawal | Assessments performed on Day 0 were considered as Baseline. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in height at Month 6 and 12 and early withdrawal were reported. |
| Primary | Mean Change From Baseline in Weight | Baseline (Day 0), Month 6, 12 and early withdrawal | Baseline values were assessed on Day 0. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in weight at Month 6, 12 and early withdrawal were reported. |
| Secondary | Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4) | Baseline (Day 0) and Month 6 | 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. |
| 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). | Baseline (Day 0), Month 6 and Month 12 | 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Baseline (Day 0) and 12 Months | 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. | Percent change in BMD | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants With Hypercalcemia | Up to Month 12 | Intent-to-Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Withdrew Due to Hypercalcemia | Up to Month 12 | Intent-to-Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit | Up to Month 12 | Intent-to-Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit | Up to 12 Months | Intent-to-Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event | Up to 12 months | Intent-to-Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline in Height | Baseline (Day 0), Month 6, 12 and early withdrawal | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Centimeter | MEAN |
| PRIMARY | Mean Change From Baseline in Weight | Baseline (Day 0), Month 6, 12 and early withdrawal | Intent-to-Treat population. Only those participants available at the specified time points were analyzed. | Kilogram | MEAN |
| SECONDARY | Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4) | Baseline (Day 0) and Month 6 | 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. | percent change in BMD | LEAST_SQUARES_MEAN |
| 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). | Baseline (Day 0), Month 6 and Month 12 | 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. | Percent change in BMD | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group718
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Placebo | 0.03 | Standard Error 0.38 | Percent change in BMD | |
| 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) | Ronacaleret, 100 mg Tablet, OD | 0.32 | Standard Error 0.40 | Percent change in BMD | |
| 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) | Ronacaleret, 200 mg Tablet, OD | 1.39 | Standard Error 0.40 | Percent change in BMD | |
| 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) | Ronacaleret, 300 mg Tablet, OD | 1.61 | Standard Error 0.39 | Percent change in BMD | |
| 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) | Ronacaleret, 400 mg Tablet, OD | 1.62 | Standard Error 0.40 | Percent change in BMD | |
| 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) | Alendronate, 70 mg, Capsule, OW | 4.54 | Standard Error 0.40 | Percent change in BMD | |
| Number of Participants With Hypercalcemia | Placebo | 0 | Participants | ||
| Number of Participants With Hypercalcemia | Ronacaleret, 100 mg Tablet, OD | 1 | Participants | ||
| Number of Participants With Hypercalcemia | Ronacaleret, 200 mg Tablet, OD | 1 | Participants | ||
| Number of Participants With Hypercalcemia | Ronacaleret, 300 mg Tablet, OD | 4 | Participants |
1 to 10 of 718Source ClinicalTrials.gov
See all 718 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 90 | |
| Overall Study | STARTED | Ronacaleret, 100 mg Tablet, OD | 87 | |
| Overall Study | STARTED | Ronacaleret, 200 mg Tablet, OD | 82 | |
| Overall Study | STARTED | Ronacaleret, 300 mg Tablet, OD | 88 | |
| Overall Study | STARTED | Ronacaleret, 400 mg Tablet, OD | 87 | |
| Overall Study | STARTED | Alendronate, 70 mg, Capsule, OW | 89 | |
| Overall Study | STARTED | Teriparatide, 20 mcg, SC Injection, OD | 41 | |
| Overall Study | COMPLETED | Placebo | 49 | |
| Overall Study | COMPLETED | Ronacaleret, 100 mg Tablet, OD | 45 | |
| Overall Study | COMPLETED | Ronacaleret, 200 mg Tablet, OD | 48 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events371
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo | 17 | 90 | |
| other | Nasopharyngitis | Infections and infestations | Ronacaleret, 100 mg Tablet, OD | 16 | 87 | |
| other | Nasopharyngitis | Infections and infestations | Ronacaleret, 200 mg Tablet, OD | 13 | 82 | |
| other | Nasopharyngitis | Infections and infestations | Ronacaleret, 300 mg Tablet, OD | 12 | 88 | |
| other | Nasopharyngitis | Infections and infestations | Ronacaleret, 400 mg Tablet, OD | 16 | 87 | |
| other | Nasopharyngitis | Infections and infestations | Alendronate, 70 mg, Capsule, OW | 12 | 89 | |
| other | Nasopharyngitis | Infections and infestations | Teriparatide, 20 mcg, SC Injection, OD | 7 | 41 | |
| other | Influenza | Infections and infestations | Placebo | 7 | 90 | |
| other | Influenza | Infections and infestations | Ronacaleret, 100 mg Tablet, OD | 6 | 87 | |
| other | Influenza | Infections and infestations | Ronacaleret, 200 mg Tablet, OD | 5 | 82 |
1 to 10 of 371Source ClinicalTrials.gov
See all 371 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 90 |
| Total, all-cause mortality | Ronacaleret, 100 mg Tablet, OD | 0 | 87 |
| Total, all-cause mortality | Ronacaleret, 200 mg Tablet, OD | 0 | 82 |
| Total, all-cause mortality | Ronacaleret, 300 mg Tablet, OD | 0 | 88 |
| Total, all-cause mortality | Ronacaleret, 400 mg Tablet, OD | 0 | 87 |
| Total, all-cause mortality | Alendronate, 70 mg, Capsule, OW | 0 | 89 |
| Total, all-cause mortality | Teriparatide, 20 mcg, SC Injection, OD | 0 | 41 |
| Total, other adverse events | Placebo | 54 | 90 |
| Total, other adverse events | Ronacaleret, 100 mg Tablet, OD | 54 | 87 |
| Total, other adverse events | Ronacaleret, 200 mg Tablet, OD | 57 | 82 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00471237
GET https://conductscience.org/api/trials/v1/NCT00471237/registered?page=2