Trial · NCT00431444
Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density
NCT00431444, Phase 4, Completed, Novartis; results first posted 2011-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density. Trials, record NCT00431444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00431444
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density
- NCT number
- NCT00431444
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 110 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Osteoporosis
- Interventions
- Raloxifene, Zoledronic acid, Placebo oral pills, Placebo intravenous (i.v.) infusion
- First posted
- 2007-02-05
- Last updated
- 2011-03-29
- Results first posted
- 2011-03-11
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Baseline and 6 months | The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine. |
| Secondary | Change From Baseline in Urine NTx at 2 Months | Baseline and 2 months | The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine. |
| Secondary | Change From Baseline in Urine NTx at 4 Months | Baseline and 4 months | The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine. |
| Secondary | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months | Baseline and 2 months | |
| Secondary | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months | Baseline and 4 months | |
| Secondary | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months | Baseline and 6 months | |
| Secondary | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Immediately after infusion procedure | The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely." |
| Secondary | Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Immediately after infusion procedure | The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely." |
| Secondary | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Immediately after infusion procedure | Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely." |
| Secondary | Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | At 6 month visit | At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: "once a year i.v. infusion," "once daily pill," or "both are equal." |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Baseline and 6 months | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed. | nM BCE/mM Cr | MEAN |
| SECONDARY | Change From Baseline in Urine NTx at 2 Months | Baseline and 2 months | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed. | nM BCE/mM Cr | MEAN |
| SECONDARY | Change From Baseline in Urine NTx at 4 Months | Baseline and 4 months | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed. | nM BCE/mM Cr | MEAN |
| SECONDARY | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months | Baseline and 2 months | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed. | U/L | MEAN |
| SECONDARY | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months | Baseline and 4 months | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed. | U/L | MEAN |
| SECONDARY | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months | Baseline and 6 months | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed. | U/L | MEAN |
| SECONDARY | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Immediately after infusion procedure | Intention-to-treat (ITT) population. | Participants | NUMBER |
| SECONDARY | Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Immediately after infusion procedure | Intention-to-treat (ITT) population. | Participants | NUMBER |
| SECONDARY | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Immediately after infusion procedure | Intention-to-treat (ITT) population. | Participants | NUMBER |
| SECONDARY | Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | At 6 month visit | Intention-to-treat (ITT) population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Zoledronic Acid | Baseline (n = 52, 53) | 49.054 | Standard Deviation 20.4515 | nM BCE/mM Cr |
| Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Raloxifene | Baseline (n = 52, 53) | 44.460 | Standard Deviation 23.2789 | nM BCE/mM Cr |
| Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Zoledronic Acid | 6 months (n = 49, 47) | 23.676 | Standard Deviation 11.9152 | nM BCE/mM Cr |
| Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Raloxifene | 6 months (n = 49, 47) | 34.183 | Standard Deviation 16.4667 | nM BCE/mM Cr |
| Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Zoledronic Acid | Change from baseline to Month 6 (n= 48, 47) | -24.646 | Standard Deviation 13.9893 | nM BCE/mM Cr |
| Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Raloxifene | Change from baseline to Month 6 (n= 48, 47) | -8.362 | Standard Deviation 15.3852 | nM BCE/mM Cr |
| Change From Baseline in Urine NTx at 2 Months | Zoledronic Acid | Baseline (n= 52, 53) | 49.054 | Standard Deviation 20.4515 | nM BCE/mM Cr |
| Change From Baseline in Urine NTx at 2 Months | Raloxifene | Baseline (n= 52, 53) | 44.460 | Standard Deviation 23.2789 | nM BCE/mM Cr |
| Change From Baseline in Urine NTx at 2 Months | Zoledronic Acid | At Month 2 (n= 54, 50) | 17.774 | Standard Deviation 9.1107 | nM BCE/mM Cr |
| Change From Baseline in Urine NTx at 2 Months | Raloxifene | At Month 2 (n= 54, 50) | 40.756 | Standard Deviation 23.3700 | nM BCE/mM Cr |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zoledronic Acid | 56 | |
| Overall Study | STARTED | Raloxifene | 53 | |
| Overall Study | COMPLETED | Zoledronic Acid | 51 | |
| Overall Study | COMPLETED | Raloxifene | 46 | |
| Overall Study | NOT COMPLETED | Zoledronic Acid | 5 | |
| Overall Study | NOT COMPLETED | Raloxifene | 7 |
Source ClinicalTrials.gov
Adverse events34
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 | Constipation | Gastrointestinal disorders | Zoledronic Acid | 1 | 56 | |
| other | Constipation | Gastrointestinal disorders | Raloxifene | 3 | 53 | |
| other | Diarrhoea | Gastrointestinal disorders | Zoledronic Acid | 5 | 56 | |
| other | Diarrhoea | Gastrointestinal disorders | Raloxifene | 1 | 53 | |
| other | Nausea | Gastrointestinal disorders | Zoledronic Acid | 7 | 56 | |
| other | Nausea | Gastrointestinal disorders | Raloxifene | 1 | 53 | |
| other | Chills | General disorders | Zoledronic Acid | 3 | 56 | |
| other | Chills | General disorders | Raloxifene | 1 | 53 | |
| other | Fatigue | General disorders | Zoledronic Acid | 3 | 56 | |
| other | Fatigue | General disorders | Raloxifene | 1 | 53 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zoledronic Acid | ||
| Total, all-cause mortality | Raloxifene | ||
| Total, other adverse events | Zoledronic Acid | 31 | 56 |
| Total, other adverse events | Raloxifene | 13 | 53 |
| Total, serious adverse events | Zoledronic Acid | 1 | 56 |
| Total, serious adverse events | Raloxifene | 1 | 53 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21796066 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Zoledronic Acid vs Raloxifene: serious adverse events |
Source 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/NCT00431444
GET https://conductscience.org/api/trials/v1/NCT00431444/results?page=2