Trial · NCT00927186
Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
NCT00927186, Phase 4, Completed, Eli Lilly and Company; results first posted 2012-03-02
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women. Trials, record NCT00927186. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00927186
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
- NCT number
- NCT00927186
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 69 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoporosis, Post-menopausal
- Interventions
- Teriparatide, Zoledronic Acid
- First posted
- 2009-06-24
- Last updated
- 2013-04-04
- Results first posted
- 2012-03-02
Source ClinicalTrials.gov
Registered outcomes56
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | 6 months | MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation. |
| Secondary | Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months | 24 months | MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation. |
| Secondary | Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months | 6 and 24 months | MS/BS in EC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation. |
| Secondary | Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | 6 months | Ac.f in CC represents the frequency of activation of new remodeling cycles on BS (bone formation rate \[BFR\]/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 micrometer (µm)/day or counted as missing. |
| Secondary | Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months | 24 months | Ac.f in CC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing. |
| Secondary | Activation Frequency (Ac.f) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months | 6 and 24 months | Ac.f in EC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing. |
| Secondary | Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | 6 months | BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (cubic millimeter/square millimeter/year \[mm³/mm²/year\]); calculated as mineral apposition rate (MAR) times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing. |
| Secondary | Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months | 24 months | BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing. |
| Secondary | Bone Formation Rate (BFR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months | 6 and 24 months | BFR in EC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing. |
| Secondary | Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | 6 months | MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive T labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing. |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 registered outcomesOutcomes56
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | 6 months | All randomized participants who received at least one dose of study drug with an evaluable bone biopsy. | percentage of surface | MEDIAN |
| SECONDARY | Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months | 24 months | All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the CC at 24 months. | percentage of surface | MEDIAN |
| SECONDARY | Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months | 6 and 24 months | All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the EC at 6 and 24 months. | percentage of surface | MEDIAN |
| SECONDARY | Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | 6 months | All randomized participants who received at least one dose of study drug with an evaluable bone biopsy. | new cycles/year | MEDIAN |
| SECONDARY | Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months | 24 months | All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the CC at 24 months. | new cycles/year | MEDIAN |
| SECONDARY | Activation Frequency (Ac.f) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months | 6 and 24 months | All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the EC at 6 and 24 months. | new cycles/year | MEDIAN |
| SECONDARY | Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | 6 months | All randomized participants who received at least one dose of study drug with an evaluable bone biopsy. | mm³/mm²/year | MEDIAN |
| SECONDARY | Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months | 24 months | All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of the CC at 24 months. | mm³/mm²/year | MEDIAN |
| SECONDARY | Bone Formation Rate (BFR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months | 6 and 24 months | All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of EC at 6 and 24 months. | mm³/mm²/year | MEDIAN |
| SECONDARY | Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | 6 months | All randomized participants who received at least one dose of study drug with an evaluable bone biopsy. | micrometer (µm)/day | MEDIAN |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 outcomesResults by group252
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | Teriparatide | 5.60 | Inter-Quartile Range 10.20 | percentage of surface | |
| Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | Zoledronic Acid | 0.16 | Inter-Quartile Range 2.62 | percentage of surface | |
| Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months | Teriparatide | 3.00 | Inter-Quartile Range 1.49 to 4.58 | percentage of surface | |
| Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months | Zoledronic Acid | 0.07 | Inter-Quartile Range 0.00 to 0.42 | percentage of surface | |
| Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months | Teriparatide | 6 months (n=23, 29) | 18.64 | Inter-Quartile Range 9.25 to 21.96 | percentage of surface |
| Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months | Zoledronic Acid | 6 months (n=23, 29) | 0.30 | Inter-Quartile Range 0.00 to 0.84 | percentage of surface |
| Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months | Teriparatide | 24 months (n=9, 8) | 5.82 | Inter-Quartile Range 3.10 to 7.08 | percentage of surface |
| Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months | Zoledronic Acid | 24 months (n=9, 8) | 0.00 | Inter-Quartile Range 0.00 to 0.91 | percentage of surface |
| Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | Teriparatide | DL and NL (n=28, 28) | 0.37 | Inter-Quartile Range 0.17 to 0.82 | new cycles/year |
| Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months | Zoledronic Acid | DL and NL (n=28, 28) | 0.01 | Inter-Quartile Range 0.00 to 0.04 | new cycles/year |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 12 Months Primary Study | STARTED | Teriparatide | 34 | |
| 12 Months Primary Study | STARTED | Zoledronic Acid | 35 | |
| 12 Months Primary Study | Completed 6 Months Double Blind Phase | Teriparatide | 28 | |
| 12 Months Primary Study | Completed 6 Months Double Blind Phase | Zoledronic Acid | 31 | |
| 12 Months Primary Study | COMPLETED | Teriparatide | 27 | |
| 12 Months Primary Study | COMPLETED | Zoledronic Acid | 31 | |
| 12 Months Primary Study | NOT COMPLETED | Teriparatide | 7 | |
| 12 Months Primary Study | NOT COMPLETED | Zoledronic Acid | 4 | |
| 12 - 24 Months Extension Treatment | STARTED | Teriparatide | 10 | |
| 12 - 24 Months Extension Treatment | STARTED | Zoledronic Acid | 11 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events106
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 | Palpitations | Cardiac disorders | Teriparatide | 0 | 34 | 0 |
| other | Palpitations | Cardiac disorders | Zoledronic Acid | 2 | 35 | 2 |
| other | Constipation | Gastrointestinal disorders | Teriparatide | 0 | 34 | 0 |
| other | Constipation | Gastrointestinal disorders | Zoledronic Acid | 2 | 35 | 2 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Teriparatide | 2 | 34 | 2 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Zoledronic Acid | 1 | 35 | 1 |
| other | Nausea | Gastrointestinal disorders | Teriparatide | 3 | 34 | 4 |
| other | Nausea | Gastrointestinal disorders | Zoledronic Acid | 4 | 35 | 5 |
| other | Vomiting | Gastrointestinal disorders | Teriparatide | 0 | 34 | 0 |
| other | Vomiting | Gastrointestinal disorders | Zoledronic Acid | 3 | 35 | 3 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide | ||
| Total, all-cause mortality | Zoledronic Acid | ||
| Total, other adverse events | Teriparatide | 31 | 34 |
| Total, other adverse events | Zoledronic Acid | 31 | 35 |
| Total, serious adverse events | Teriparatide | 2 | 34 |
| Total, serious adverse events | Zoledronic Acid | 3 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26841258 | 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 |
|---|
| Teriparatide vs Zoledronic Acid: 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/NCT00927186
GET https://conductscience.org/api/trials/v1/NCT00927186/registered?page=2