Trial · NCT02089997
Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)
NCT02089997, Completed, Takeda; results first posted 2018-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey). Trials, record NCT02089997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02089997
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)
- NCT number
- NCT02089997
- Status
- Completed
- Enrollment
- 3,304 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Osteoporosis
- Interventions
- Sodium Risedronate
- First posted
- 2014-03-18
- Last updated
- 2018-10-19
- Results first posted
- 2018-10-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Up to Month 12 | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment. |
| Secondary | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. |
| Secondary | Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the femur (neck region) at end of study relative to baseline. |
| Secondary | Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at end of study relative to baseline. |
| Secondary | Percent Change From Baseline in Radius BMD at Final Assessment | Baseline and final assessment (up to Month 12) | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the radius at end of study relative to baseline. |
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment | Baseline and final assessment (up to Month 12) | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. |
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Baseline and final assessment (up to Month 12) | Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Up to Month 12 | Safety Analysis Set was defined as all participants who were enrolled and completed the study. | Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment | Baseline and final assessment (up to Month 12) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment | Baseline and final assessment (up to Month 12) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment | Baseline and final assessment (up to Month 12) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Radius BMD at Final Assessment | Baseline and final assessment (up to Month 12) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Baseline and final assessment (up to Month 12) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment | Baseline and final assessment (up to Month 12) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment | Baseline and final assessment (up to Month 12) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment | Baseline and final assessment (up to Month 12) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Baseline and final assessment (up to Month 12) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure. | Percent change | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Sodium Risedronate 75 mg | 231 | Participants | ||
| Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment | Sodium Risedronate 75 mg | 4.700 | Standard Deviation 12.118 | Percent change | |
| Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment | Sodium Risedronate 75 mg | 1.008 | Standard Deviation 5.473 | Percent change | |
| Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment | Sodium Risedronate 75 mg | 1.745 | Standard Deviation 5.180 | Percent change | |
| Percent Change From Baseline in Radius BMD at Final Assessment | Sodium Risedronate 75 mg | 1.173 | Standard Deviation 6.909 | Percent change | |
| Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Sodium Risedronate 75 mg | -14.024 | Standard Deviation 27.863 | Percent change | |
| Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment | Sodium Risedronate 75 mg | -32.016 | Standard Deviation 30.219 | Percent change | |
| Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment | Sodium Risedronate 75 mg | -19.449 | Standard Deviation 28.058 | Percent change | |
| Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment | Sodium Risedronate 75 mg | -46.302 | Standard Deviation 30.482 | Percent change | |
| Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Sodium Risedronate 75 mg | -22.010 | Standard Deviation 60.634 | Percent change |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sodium Risedronate 75 mg | 3,304 | |
| Overall Study | COMPLETED | Sodium Risedronate 75 mg | 3,058 | |
| Overall Study | NOT COMPLETED | Sodium Risedronate 75 mg | 246 |
Source ClinicalTrials.gov
Adverse events15
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 | Diarrhoea | Gastrointestinal disorders | Sodium Risedronate 75 mg | 19 | 3,058 | |
| other | Nausea | Gastrointestinal disorders | Sodium Risedronate 75 mg | 28 | 3,058 | |
| other | Pyrexia | General disorders | Sodium Risedronate 75 mg | 24 | 3,058 | |
| serious | Pneumonia | Infections and infestations | Sodium Risedronate 75 mg | 1 | 3,058 | |
| serious | Cerebral haemorrhage | Nervous system disorders | Sodium Risedronate 75 mg | 2 | 3,058 | |
| serious | Cardiac hypertrophy | Cardiac disorders | Sodium Risedronate 75 mg | 1 | 3,058 | |
| serious | Aortic valve stenosis | Cardiac disorders | Sodium Risedronate 75 mg | 1 | 3,058 | |
| serious | Hypertension | Vascular disorders | Sodium Risedronate 75 mg | 1 | 3,058 | |
| serious | Back pain | Musculoskeletal and connective tissue disorders | Sodium Risedronate 75 mg | 1 | 3,058 | |
| serious | Collagen disorder | Musculoskeletal and connective tissue disorders | Sodium Risedronate 75 mg | 1 | 3,058 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Risedronate 75 mg | ||
| Total, other adverse events | Sodium Risedronate 75 mg | 71 | 3,058 |
| Total, serious adverse events | Sodium Risedronate 75 mg | 15 | 3,058 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02089997
GET https://conductscience.org/api/trials/v1/NCT02089997/registered