Trial · NCT01473602
Second Study of the Effect of Teriparatide on Hip Fracture Healing
NCT01473602, Phase 3, Completed, Eli Lilly and Company; results first posted 2014-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Second Study of the Effect of Teriparatide on Hip Fracture Healing. Trials, record NCT01473602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01473602
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Second Study of the Effect of Teriparatide on Hip Fracture Healing
- NCT number
- NCT01473602
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 39 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Femur Neck Fracture
- Interventions
- Teriparatide, Placebo, Calcium supplementation, Vitamin D supplementation
- First posted
- 2011-11-17
- Last updated
- 2015-04-16
- Results first posted
- 2014-11-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture | 12 months | Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure. |
| Secondary | Percentage of Participants With Radiographic Evidence of Healing | Randomization up to 12 months | The signs of femoral neck fracture healing and healing complications included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing. Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) \* 100. |
| Secondary | Percentage of Participants With Pain Control During Ambulation | Up to 12 months | The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Higher scores indicated more severe pain. Participants with an NRS score of \<7 and no worsening of NRS scores \>2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) \* 100. |
| Secondary | Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit | Up to 12 months | The NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of \<7 in the 24 hours preceding a visit and no worsening of NRS score \>2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants analyzed) \* 100. |
| Secondary | Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing | Up to 12 months | The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of \<7 during weight bearing and no worsening of NRS score \>2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) \* 100. |
| Secondary | Percentage of Participants With Functional Evidence of Healing | Up to 12 Months | Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) \* 100. |
| Secondary | Percentage of Participants Able to Ambulate | Up to 12 months | Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) \* 100. |
| Secondary | Percentage of Participants Who Regained Their Prefracture Ambulatory Status | Up to 12 months | Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number of participants analyzed) \*100. |
| Secondary | Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | Baseline, 6 Months | The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of \<7 were categorized as having no severe fracture-site pain. Least squares (LS) means was calculated using analysis of covariance (ANCOVA) adjusted for baseline, treatment group, region, fracture type, and fixation type. |
| Secondary | Mean Change From Baseline to 6 Months in Gait Speed | Baseline, 6 Months | The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, and fixation type |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture | 12 months | Participants who were randomized, received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Radiographic Evidence of Healing | Randomization up to 12 months | Participants who were randomized and received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain Control During Ambulation | Up to 12 months | Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit | Up to 12 months | Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours.. LOCF values used. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing | Up to 12 months | Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement. LOCF values used. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Functional Evidence of Healing | Up to 12 Months | Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Able to Ambulate | Up to 12 months | Participants who were randomized, received treatment and had at least 1 nonmissing post-baseline measurement. LOCF values used | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Regained Their Prefracture Ambulatory Status | Up to 12 months | Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used. | Percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain | Baseline, 6 Months | Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement.. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 6 Months in Gait Speed | Baseline, 6 Months | Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement. | m/s | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture | Teriparatide | 74 | 90% Confidence Interval 51 to 88 | Percentage of participants | |
| Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture | Placebo | 93 | 90% Confidence Interval 70 to 99 | Percentage of participants | |
| Percentage of Participants With Radiographic Evidence of Healing | Teriparatide | 55.6 | Percentage of participants | ||
| Percentage of Participants With Radiographic Evidence of Healing | Placebo | 65.0 | Percentage of participants | ||
| Percentage of Participants With Pain Control During Ambulation | Teriparatide | 90.0 | Percentage of participants | ||
| Percentage of Participants With Pain Control During Ambulation | Placebo | 100.0 | Percentage of participants | ||
| Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit | Teriparatide | 81.8 | Percentage of participants | ||
| Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit | Placebo | 92.9 | Percentage of participants | ||
| Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing | Teriparatide | 90.9 | Percentage of participants | ||
| Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing | Placebo | 84.6 | Percentage of participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriparatide | 18 | |
| Overall Study | STARTED | Placebo | 21 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Teriparatide | 18 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 20 | |
| Overall Study | Completed 6 Months | Teriparatide | 12 | |
| Overall Study | Completed 6 Months | Placebo | 15 | |
| Overall Study | Completed 12 Months | Teriparatide | 10 | |
| Overall Study | Completed 12 Months | Placebo | 13 | |
| Overall Study | COMPLETED | Teriparatide | 10 | |
| Overall Study | COMPLETED | Placebo | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events144
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 | Hyperchlorhydria | Gastrointestinal disorders | Placebo | 0 | 20 | 0 |
| other | Hyperchlorhydria | Gastrointestinal disorders | Teriparatide | 1 | 18 | 1 |
| other | Hyperchlorhydria | Gastrointestinal disorders | Placebo Follow-up | 0 | 15 | 0 |
| other | Hyperchlorhydria | Gastrointestinal disorders | Teriparatide Follow-up | 0 | 12 | 0 |
| other | Toothache | Gastrointestinal disorders | Placebo | 1 | 20 | 1 |
| other | Toothache | Gastrointestinal disorders | Teriparatide | 0 | 18 | 0 |
| other | Toothache | Gastrointestinal disorders | Placebo Follow-up | 0 | 15 | 0 |
| other | Toothache | Gastrointestinal disorders | Teriparatide Follow-up | 0 | 12 | 0 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 0 | 20 | 0 |
| other | Vomiting | Gastrointestinal disorders | Teriparatide | 0 | 18 | 0 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Teriparatide | ||
| Total, all-cause mortality | Placebo Follow-up | ||
| Total, all-cause mortality | Teriparatide Follow-up | ||
| Total, other adverse events | Placebo | 5 | 20 |
| Total, other adverse events | Teriparatide | 3 | 18 |
| Total, other adverse events | Placebo Follow-up | 4 | 15 |
| Total, other adverse events | Teriparatide Follow-up | 3 | 12 |
| Total, serious adverse events | Placebo | 2 | 20 |
| Total, serious adverse events | Teriparatide | 1 | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01473602
GET https://conductscience.org/api/trials/v1/NCT01473602/results?page=2