Trial · NCT00404820
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
NCT00404820, Phase 3, Completed, Novartis; results first posted 2011-07-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis. Trials, record NCT00404820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00404820
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
- NCT number
- NCT00404820
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 604 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Osteoporosis
- Interventions
- Zoledronic acid 5 mg solution, Alendronate 70 mg tablets, Calcium/Vitamin D
- First posted
- 2006-11-29
- Last updated
- 2011-07-01
- Results first posted
- 2011-07-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population | Screening to end of study (Month 12) | The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study. |
| Primary | Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population | Screening to end of study (Month 12) | The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study. |
| Secondary | Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 | Screening to end of study (Month 12) | The level of bone activity as measured by P1NP over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study. |
| Secondary | Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12 | Baseline to end of study (Month 12) | The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement. |
| Secondary | Number of Patients With a Clinical Fracture From Baseline to Month 12 | Baseline to end of study (Month 12) | A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain. |
| Secondary | Change in Body Height From Baseline to Month 12 | Baseline to end of study (Month 12) | Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated. |
| Secondary | Therapy Preference at End of Study (Month 12) | Month 12 | Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population | Screening to end of study (Month 12) | Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level. | ng/ml | MEAN |
| SECONDARY | Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 | Screening to end of study (Month 12) | Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level. | ng/ml | MEAN |
| SECONDARY | Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12 | Baseline to end of study (Month 12) | Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level. | Units on a scale | MEAN |
| SECONDARY | Number of Patients With a Clinical Fracture From Baseline to Month 12 | Baseline to end of study (Month 12) | Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level. | Participants | NUMBER |
| SECONDARY | Change in Body Height From Baseline to Month 12 | Baseline to end of study (Month 12) | Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level. | cm | MEAN |
| SECONDARY | Therapy Preference at End of Study (Month 12) | Month 12 | Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level. | Participants | NUMBER |
| PRIMARY | Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population | Screening to end of study (Month 12) | Per Protocol population: All intent-to-treat patients who did not show major deviations from the protocol procedures that may have had an impact on the study outcome. | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population | Zoledronic Acid 5 mg | 0.282 | Standard Deviation 0.195 | ng/ml | |
| Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population | Alendronate 70 mg | 0.270 | Standard Deviation 0.266 | ng/ml | |
| Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 | Zoledronic Acid 5 mg | 28.2 | Standard Deviation 23.0 | ng/ml | |
| Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 | Alendronate 70 mg | 25.5 | Standard Deviation 17.6 | ng/ml | |
| Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12 | Zoledronic Acid 5 mg | -1.2 | Standard Deviation 8.8 | Units on a scale | |
| Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12 | Alendronate 70 mg | -0.6 | Standard Deviation 9.0 | Units on a scale | |
| Number of Patients With a Clinical Fracture From Baseline to Month 12 | Zoledronic Acid 5 mg | 10 | Participants | ||
| Number of Patients With a Clinical Fracture From Baseline to Month 12 | Alendronate 70 mg | 4 | Participants | ||
| Change in Body Height From Baseline to Month 12 | Zoledronic Acid 5 mg | -0.1 | Standard Deviation 1.0 | cm | |
| Change in Body Height From Baseline to Month 12 | Alendronate 70 mg | 0.0 | Standard Deviation 1.2 | cm |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zoledronic Acid 5 mg | 408 | |
| Overall Study | STARTED | Alendronate 70 mg | 196 | |
| Overall Study | Started Treatment | Zoledronic Acid 5 mg | 408 | |
| Overall Study | Started Treatment | Alendronate 70 mg | 194 | |
| Overall Study | COMPLETED | Zoledronic Acid 5 mg | 389 | |
| Overall Study | COMPLETED | Alendronate 70 mg | 172 | |
| Overall Study | NOT COMPLETED | Zoledronic Acid 5 mg | 19 | |
| Overall Study | NOT COMPLETED | Alendronate 70 mg | 24 |
Source ClinicalTrials.gov
Adverse events170
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 | Zoledronic Acid 5 mg | 12 | 408 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Alendronate 70 mg | 13 | 194 | |
| other | Constipation | Gastrointestinal disorders | Zoledronic Acid 5 mg | 9 | 408 | |
| other | Constipation | Gastrointestinal disorders | Alendronate 70 mg | 10 | 194 | |
| other | Diarrhoea | Gastrointestinal disorders | Zoledronic Acid 5 mg | 9 | 408 | |
| other | Diarrhoea | Gastrointestinal disorders | Alendronate 70 mg | 10 | 194 | |
| other | Dyspepsia | Gastrointestinal disorders | Zoledronic Acid 5 mg | 3 | 408 | |
| other | Dyspepsia | Gastrointestinal disorders | Alendronate 70 mg | 14 | 194 | |
| other | Nausea | Gastrointestinal disorders | Zoledronic Acid 5 mg | 23 | 408 | |
| other | Nausea | Gastrointestinal disorders | Alendronate 70 mg | 11 | 194 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zoledronic Acid 5 mg | ||
| Total, all-cause mortality | Alendronate 70 mg | ||
| Total, other adverse events | Zoledronic Acid 5 mg | 267 | 408 |
| Total, other adverse events | Alendronate 70 mg | 94 | 194 |
| Total, serious adverse events | Zoledronic Acid 5 mg | 43 | 408 |
| Total, serious adverse events | Alendronate 70 mg | 21 | 194 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Zoledronic Acid 5 mg vs Alendronate 70 mg: Number of Patients With a Clinical Fracture From Baseline to Month 12 | Trial comparisons |
| Zoledronic Acid 5 mg vs Alendronate 70 mg: 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/NCT00404820
GET https://conductscience.org/api/trials/v1/NCT00404820/events?page=2