Trial · NCT01512446
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
NCT01512446, Phase 3, Terminated, Evangelisches Krankenhaus Lutherhaus gGmbH; results first posted 2019-01-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy. Trials, record NCT01512446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01512446
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
- NCT number
- NCT01512446
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 436 participants, actual
- Lead sponsor
- Evangelisches Krankenhaus Lutherhaus gGmbH
- Conditions
- Osteoporosis
- Interventions
- Alendronate, Placebo
- First posted
- 2012-01-19
- Last updated
- 2019-02-12
- Other registries' IDs
- eudract:2011-000290-31
- Results first posted
- 2019-01-17
- Limitations and caveats
- Due to a low recruitment rate, the study was early terminated.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of New Osteoporotic Fractures | From baseline to study termination (mean duration 5.6 months) | Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes. |
| Secondary | Mortality | From baseline to study termination (mean duration 5.6 months) | Number of deaths |
| Secondary | Combination of New Osteoporotic Fractures and Deaths | From baseline to study termination (mean duration 5.6 months) | Number of participants with a new osteoporotic fracture or death |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of New Osteoporotic Fractures | From baseline to study termination (mean duration 5.6 months) | Full Analysis Set (all randomized participants) | osteoporotic fractures | NUMBER |
| SECONDARY | Mortality | From baseline to study termination (mean duration 5.6 months) | Full Analysis Set (all randomized participants) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Combination of New Osteoporotic Fractures and Deaths | From baseline to study termination (mean duration 5.6 months) | Full Analysis Set (all randomized participants) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of New Osteoporotic Fractures | Placebo | 5 | osteoporotic fractures | ||
| Number of New Osteoporotic Fractures | Alendronate | 5 | osteoporotic fractures | ||
| Mortality | Placebo | 2 | Participants | ||
| Mortality | Alendronate | 0 | Participants | ||
| Combination of New Osteoporotic Fractures and Deaths | Placebo | 7 | Participants | ||
| Combination of New Osteoporotic Fractures and Deaths | Alendronate | 5 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 221 | |
| Overall Study | STARTED | Alendronate | 215 | |
| Overall Study | Safety Analysis Set | Placebo | 197 | |
| Overall Study | Safety Analysis Set | Alendronate | 188 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Alendronate | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 221 | |
| Overall Study | NOT COMPLETED | Alendronate | 215 |
Source ClinicalTrials.gov
Adverse events166
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 | Abdominal pain upper | Gastrointestinal disorders | Placebo | 23 | 197 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Alendronate | 15 | 188 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 23 | 197 | |
| other | Constipation | Gastrointestinal disorders | Alendronate | 11 | 188 | |
| other | Tooth disorder | Gastrointestinal disorders | Placebo | 11 | 197 | |
| other | Tooth disorder | Gastrointestinal disorders | Alendronate | 9 | 188 | |
| other | Fatigue | General disorders | Placebo | 30 | 197 | |
| other | Fatigue | General disorders | Alendronate | 27 | 188 | |
| other | Hyperhidrosis | General disorders | Placebo | 30 | 197 | |
| other | Hyperhidrosis | General disorders | Alendronate | 21 | 188 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Alendronate | ||
| Total, other adverse events | Placebo | 113 | 197 |
| Total, other adverse events | Alendronate | 94 | 188 |
| Total, serious adverse events | Placebo | 38 | 197 |
| Total, serious adverse events | Alendronate | 31 | 188 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Alendronate vs Placebo: Combination of New Osteoporotic Fractures and Deaths | Trial comparisons |
| Alendronate vs Placebo: Mortality | Trial comparisons |
| Alendronate vs Placebo: serious adverse events | Trial comparisons |
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/NCT01512446
GET https://conductscience.org/api/trials/v1/NCT01512446/events?page=2