Trial · NCT00439244
Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
NCT00439244, Phase 3, Completed, Novartis; results first posted 2011-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis. Trials, record NCT00439244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00439244
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
- NCT number
- NCT00439244
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 412 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Osteoporosis
- Interventions
- Zoledronic acid, Placebo, Teriparatide
- First posted
- 2007-02-23
- Last updated
- 2011-04-20
- Results first posted
- 2011-04-20
- Limitations and caveats
No teriparatide placebo available, Short study duration, Only bone mineral data, No bone strength or bone stucture assessment, No bone turnover markers data between 8 and 26 weeks, Study not powered for fracture outcomes.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 | Baseline through Week 52 | BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation. |
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | Baseline through Week 13 and Week 26 | BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation. |
| Secondary | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | Baseline through Week 13, Week 26 and Week 52 | BMD measurements of the total hip by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation. |
| Secondary | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52 | Specialized tests for markers of bone formation such as n-terminal propeptide of type I collagen (P1NP) were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum P1NP was determined by the central laboratory. |
| Secondary | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52 | Specialized tests for markers of bone formation such as β-CTx were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum β-CTx was determined by the central laboratory. |
Source ClinicalTrials.gov
Outcomes5
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 Lumbar Spine Bone Mineral Density (BMD) at Week 52 | Baseline through Week 52 | The intent-to-treat (ITT) population consisted of all randomized patients with available data. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | Baseline through Week 13 and Week 26 | The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | Baseline through Week 13, Week 26 and Week 52 | The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) | At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52 | The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window | ng/mL | MEAN |
| SECONDARY | Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx) | At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52 | The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group54
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 Lumbar Spine Bone Mineral Density (BMD) at Week 52 | Zoledronic Acid Plus Teriparatide | 7.51 | Standard Error 0.414 | Percent change | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 | Zoledronic Acid | 4.37 | Standard Error 0.401 | Percent change | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 | Placebo Zoledronic Acid Plus Teriparatide | 7.05 | Standard Error 0.398 | Percent change | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | Zoledronic Acid Plus Teriparatide | At Week 13 (n= 127, 131, 131) | 4.65 | Standard Error 0.302 | Percent Change |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | Zoledronic Acid | At Week 13 (n= 127, 131, 131) | 2.97 | Standard Error 0.297 | Percent Change |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | Placebo Zoledronic Acid Plus Teriparatide | At Week 13 (n= 127, 131, 131) | 2.88 | Standard Error 0.297 | Percent Change |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | Zoledronic Acid Plus Teriparatide | At Week 26 (n= 128, 130, 132) | 6.31 | Standard Error 0.337 | Percent Change |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | Zoledronic Acid | At Week 26 (n= 128, 130, 132) | 3.87 | Standard Error 0.333 | Percent Change |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26 | Placebo Zoledronic Acid Plus Teriparatide | At Week 26 (n= 128, 130, 132) | 4.45 | Standard Error 0.330 | Percent Change |
| Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52 | Zoledronic Acid Plus Teriparatide | At Week 13 (n= 127, 133, 133) | 2.54 | Standard Error 0.222 | Percent Change |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zoledronic Acid Plus Teriparatide | 137 | |
| Overall Study | STARTED | Zoledronic Acid | 137 | |
| Overall Study | STARTED | Placebo Zoledronic Acid Plus Teriparatide | 138 | |
| Overall Study | Safety Population | Zoledronic Acid Plus Teriparatide | 137 | |
| Overall Study | Safety Population | Zoledronic Acid | 137 | |
| Overall Study | Safety Population | Placebo Zoledronic Acid Plus Teriparatide | 137 | |
| Overall Study | COMPLETED | Zoledronic Acid Plus Teriparatide | 126 | |
| Overall Study | COMPLETED | Zoledronic Acid | 131 | |
| Overall Study | COMPLETED | Placebo Zoledronic Acid Plus Teriparatide | 131 | |
| Overall Study | NOT COMPLETED | Zoledronic Acid Plus Teriparatide | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events300
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 | Vertigo | Ear and labyrinth disorders | Zoledronic Acid | 7 | 137 | |
| other | Vertigo | Ear and labyrinth disorders | Zoledronic Acid Plus Teriparatide | 5 | 137 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo Zoledronic Acid Plus Teriparatide | 9 | 137 | |
| other | Constipation | Gastrointestinal disorders | Zoledronic Acid | 8 | 137 | |
| other | Constipation | Gastrointestinal disorders | Zoledronic Acid Plus Teriparatide | 10 | 137 | |
| other | Constipation | Gastrointestinal disorders | Placebo Zoledronic Acid Plus Teriparatide | 9 | 137 | |
| other | Diarrhoea | Gastrointestinal disorders | Zoledronic Acid | 6 | 137 | |
| other | Diarrhoea | Gastrointestinal disorders | Zoledronic Acid Plus Teriparatide | 5 | 137 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Zoledronic Acid Plus Teriparatide | 11 | 137 | |
| other | Dyspepsia | Gastrointestinal disorders | Zoledronic Acid | 4 | 137 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zoledronic Acid | ||
| Total, all-cause mortality | Zoledronic Acid Plus Teriparatide | ||
| Total, all-cause mortality | Placebo Zoledronic Acid Plus Teriparatide | ||
| Total, other adverse events | Zoledronic Acid | 115 | 137 |
| Total, other adverse events | Zoledronic Acid Plus Teriparatide | 118 | 137 |
| Total, other adverse events | Placebo Zoledronic Acid Plus Teriparatide | 96 | 137 |
| Total, serious adverse events | Zoledronic Acid | 20 | 137 |
| Total, serious adverse events | Zoledronic Acid Plus Teriparatide | 13 | 137 |
| Total, serious adverse events | Placebo Zoledronic Acid Plus Teriparatide | 15 | 137 |
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.
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Read this trial from software.
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