Trial · NCT00489918
Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
NCT00489918, Phase 2, Completed, Zosano Pharma Corporation; results first posted 2018-07-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis. Trials, record NCT00489918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00489918
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
- NCT number
- NCT00489918
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 165 participants, actual
- Lead sponsor
- Zosano Pharma Corporation
- Conditions
- Osteoporosis
- Interventions
- teriparatide, teriparatide
- First posted
- 2007-06-21
- Last updated
- 2018-07-31
- Results first posted
- 2018-07-31
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 in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 | 24 weeks | Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24 |
| Secondary | Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12 | 12 weeks | Percent Change in Lumbar Spine Bone Mineral Density from Baseline to Week 12 |
| Secondary | Absolute Change in Lumbar Spine BMD: Baseline to Week 12 | 12 weeks | Absolute Change in Lumbar Spine BMD from Baseline to Week 12 |
| Secondary | Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24 | 24 Weeks | Percent Change in Total Hip Bone Mineral Density from Baseline to Week 24 |
| Secondary | Percent Change in Femoral Neck BMD: Baseline to Week 24 | 24 Weeks | Percent Change in Femoral Neck BMD from Baseline to Week 24 |
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 in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 | 24 weeks | Intent to treat (ITT)/Safety Population | percent change | MEAN |
| SECONDARY | Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12 | 12 weeks | ITT/Safety Population | Percent change | MEAN |
| SECONDARY | Absolute Change in Lumbar Spine BMD: Baseline to Week 12 | 12 weeks | ITT/Safety Population | g/cm^2 | MEAN |
| SECONDARY | Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24 | 24 Weeks | ITT/Safety Population | Percent change | MEAN |
| SECONDARY | Percent Change in Femoral Neck BMD: Baseline to Week 24 | 24 Weeks | ITT/Safety Population | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 | Macroflux® Placebo | -0.33 | Standard Deviation 3.467 | percent change | |
| Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 | Macroflux® 20 mcg | 2.96 | Standard Deviation 3.524 | percent change | |
| Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 | Macroflux® 30 mcg | 3.47 | Standard Deviation 3.575 | percent change | |
| Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 | Macroflux® 40 mcg | 4.97 | Standard Deviation 4.114 | percent change | |
| Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 | FORTEO® | 3.55 | Standard Deviation 3.730 | percent change | |
| Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12 | Macroflux® Placebo | 0.97 | Standard Deviation 3.312 | Percent change | |
| Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12 | Macroflux® 20 mcg | 1.55 | Standard Deviation 2.606 | Percent change | |
| Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12 | Macroflux® 30 mcg | 2.04 | Standard Deviation 3.277 | Percent change | |
| Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12 | Macroflux® 40 mcg | 2.5 | Standard Deviation 2.86 | Percent change | |
| Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12 | FORTEO® | 2.81 | Standard Deviation 2.771 | Percent change |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macroflux® Placebo | 33 | |
| Overall Study | STARTED | Macroflux® 20 mcg | 34 | |
| Overall Study | STARTED | Macroflux® 30 mcg | 32 | |
| Overall Study | STARTED | Macroflux® 40 mcg | 33 | |
| Overall Study | STARTED | FORTEO® | 33 | |
| Overall Study | COMPLETED | Macroflux® Placebo | 31 | |
| Overall Study | COMPLETED | Macroflux® 20 mcg | 32 | |
| Overall Study | COMPLETED | Macroflux® 30 mcg | 28 | |
| Overall Study | COMPLETED | Macroflux® 40 mcg | 32 | |
| Overall Study | COMPLETED | FORTEO® | 32 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events140
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 | Application site erythema | Skin and subcutaneous tissue disorders | Macroflux® Placebo | 13 | 33 | |
| other | Application site erythema | Skin and subcutaneous tissue disorders | Macroflux® 20 mcg | 13 | 34 | |
| other | Application site erythema | Skin and subcutaneous tissue disorders | Macroflux® 30 mcg | 15 | 32 | |
| other | Application site erythema | Skin and subcutaneous tissue disorders | Macroflux® 40 mcg | 13 | 33 | |
| other | Application site erythema | Skin and subcutaneous tissue disorders | FORTEO® | 1 | 33 | |
| other | Application site discolorations | Skin and subcutaneous tissue disorders | Macroflux® Placebo | 3 | 33 | |
| other | Application site discolorations | Skin and subcutaneous tissue disorders | Macroflux® 20 mcg | 11 | 34 | |
| other | Application site discolorations | Skin and subcutaneous tissue disorders | Macroflux® 30 mcg | 11 | 32 | |
| other | Application site discolorations | Skin and subcutaneous tissue disorders | Macroflux® 40 mcg | 7 | 33 | |
| other | Application site discolorations | Skin and subcutaneous tissue disorders | FORTEO® | 0 | 33 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macroflux® Placebo | ||
| Total, all-cause mortality | Macroflux® 20 mcg | ||
| Total, all-cause mortality | Macroflux® 30 mcg | ||
| Total, all-cause mortality | Macroflux® 40 mcg | ||
| Total, all-cause mortality | FORTEO® | ||
| Total, other adverse events | Macroflux® Placebo | 29 | 33 |
| Total, other adverse events | Macroflux® 20 mcg | 32 | 34 |
| Total, other adverse events | Macroflux® 30 mcg | 31 | 32 |
| Total, other adverse events | Macroflux® 40 mcg | 30 | 33 |
| Total, other adverse events | FORTEO® | 23 | 33 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19858319 | 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 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/NCT00489918
GET https://conductscience.org/api/trials/v1/NCT00489918/results?page=2