Trial · NCT06303284
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | Intervention-related complications | 12 weeks (treatment period) | Proportion of participants experiencing complications attributable to the study intervention, comprising local injection site irritation, hypercalcemia, and intolerance of study medication. Serum calcium is measured at every study visit from a morning sample drawn before that day's dose of study medication. |
| Secondary | All-cause mortality | 90 days post-randomization | Proportion of participants who die from any cause, with cause of death recorded. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06303284/registered