Trial · NCT06303284
PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot)
NCT06303284, Phase 1, Phase 2, Not yet recruiting, University of Calgary
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot). Trials, record NCT06303284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06303284
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot)
- NCT number
- NCT06303284
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 54 participants, estimated
- Lead sponsor
- University of Calgary
- Conditions
- Lower Extremity Fractures, Pelvis, Acetabulum
- Interventions
- subcutaneous Teriparatide injection
- First posted
- 2024-03-12
- Last updated
- 2026-10-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participant recruitment rate | 2 years | Estimate of the mean monthly recruitment rate |
| Secondary | Treatment fidelity | 6 months post randomization | Proportion of participants randomized to Teriparatide who receive 80% or more of the trial medication. Determined from a participant-maintained drug diary, weekly telephone confirmation, and return of used and unused study medication pens at each follow-up, recorded at each visit until trial medication is completed. Assessed against a priori progression criteria: green (proceed) greater than 50%; amber (amend) 20% to 50%; red (stop) less than 20%. |
| Secondary | Participant retention rate | 6 months post randomization | Proportion of enrolled participants who complete the pilot trial protocol or reach a study endpoint, reported at each follow-up timepoint. Assessed against a priori progression criteria: green (proceed) greater than 80%; amber (amend) 40% to 80%; red (stop) less than 40%. |
| Secondary | Consent Rate | 18 months (recruitment period) | Proportion of screened patients who meet eligibility criteria and provide informed or surrogate consent, together with the reasons recorded for non-consent among otherwise eligible patients. |
| Secondary | Barriers to trial implementation | Through study completion, approximately 24 months | Descriptive assessment of barriers encountered during trial conduct, comprising time to receive Research Ethics Board approval, time required for contract completion, time from approvals to first participant enrolled, data capture and study management barriers, study team infrastructure challenges, participant-level and site-level challenges, intervention-related challenges, longitudinal study design challenges, and the frequency and nature of protocol deviations. |
| Secondary | Time to fracture union | 6 months post randomization. | Time from randomization to radiographic fracture union, assessed on imaging obtained as part of routine clinical care. Long bone fractures are scored using the modified Radiographic Union Scale for Tibia (mRUST). For pelvic and acetabular fractures, where no validated radiographic union score is established, healing is assessed as the presence or absence of radiographic union. All assessments are adjudicated by two independent reviewers blinded to treatment allocation, with a third blinded reviewer resolving disagreement. |
| Secondary | Non-union | 6 months post randomization | Proportion of participants with non-union, defined as failure to achieve radiographic union within six months of randomization, or intervention required for failure to heal. Assessed by blinded adjudication as described for time to fracture union. |
| Secondary | Unplanned surgical intervention | 6 months post-randomization | Proportion of participants undergoing unplanned surgical intervention related to the index fracture, with the indication for surgery recorded. Among participants managed operatively, this includes re-operation for implant failure, loss of reduction, non-union or malunion. |
| Secondary | Fracture-related infection | 6 month post randomization | Proportion of participants requiring oral antibiotics, intravenous antibiotics, or surgical debridement for infection related to the index fracture. |
| Secondary | Bone mineral density | Baseline and 3 months post-randomization | Bone mineral density measured by dual-energy x-ray absorptiometry (DEXA). A scan performed within six months prior to randomization may be used as the baseline measurement; where no such scan is available, baseline DEXA is performed within 14 days of randomization. A repeat scan is performed at three months post-randomization, corresponding to the end of the treatment period. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers41
The papers the trial lists on ClinicalTrials.gov.
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/NCT06303284
GET https://conductscience.org/api/trials/v1/NCT06303284/papers?page=2