Trial · NCT03424018
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baselines in mean annualized growth velocity | Through study completion, an average of 1 year | Long term efficacy as measured by change in annualized growth velocity |
| Secondary | Changes in health-related quality of life as measured by the Quality of Life in Short-Statured Youth questionnaire | Through study completion, every 6-12 months | |
| Secondary | Potential changes in daily activity performance as measured by Activities of Daily Living questionnaire | Through study completion, every 12 months | |
| Secondary | Characterize maximum concentration (Cmax) of BMN 111 in plasma | Through study completion, every 12 months | |
| Secondary | Characterize the area under the plasma concentration time-curve from time 0 to infinity (AUC0-∞) | Through study completion, every 12 months | |
| Secondary | Characterize the area under the plasma concentration time-curve from time 0 to the last measurable concentration (AUC0-t) | Through study completion, every 12 months | |
| Secondary | Characterize the elimination half-life of BMN 111 (t1⁄2) | Through study completion, every 12 months | |
| Secondary | Characterize the apparent clearance of drug | Through study completion, every 12 months | |
| Secondary | Characterize the apparent volume of distribution based upon the terminal phase (Vz/F) | Through study completion, every 12 months | |
| Secondary | Characterize the amount of time BMN 111 is present at maximum concentration (Tmax) | Through study completion, every 12 months | |
| Secondary | BMN 111 Activity Biomarkers | Through study completion, every 12 months | BMN 111 activity will be assessed by measuring bone and collagen metabolism |
| Secondary | Evaluate change from baseline in body proportion ratios of the extremities | Through study completion, every 6 months | |
| Secondary | Effect of BMN 111 on bone morphology and quality | Through study completion, every 12 months for DXA or 2 years for X-ray | The effect of BMN 111 on bone morphology/quality will be assessed by measuring bone mineral density via X-Ray and Dual X-ray Absorptiometry |
| Secondary | Final Adult Height | Up to at least 16 years of age for females and 18 years of age for males | Height at 16 years for females and 18 years for males |
| Other | Optional exploratory genomic biomarker analysis | Once through study completion | Exploratory genomic analysis of genes associated with CNP signaling |
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.
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GET https://conductscience.org/api/trials/v1/NCT03424018/registered