Trial · NCT04307953
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of new active HO lesions on [18F] NaF PET/ CT | Baseline, month 6 | The change between the two arms in development of new active heterotopic bone lesions measured by \[18F\] NaF PET/low-dose whole body CT during the initial 6-month RCT |
| Secondary | Safety and tolerability assessments are the incidence and severity of adverse events (AE) during the RCT at the end of week 26. | Baseline, month 6 (+overall duration study) | |
| Secondary | New active HO lesions of the placebo arm during 26 weeks RCT compared to its roll over to 26-week open label treatment | Baseline, month 6, month 12 | Number of individual new active HO lesions assessed by \[18F\]-NaF PET between the placebo arm at week 26 and the subsequent open-label phase at week 52 among patients receiving placebo during the RCT |
| Secondary | The change in heterotopic bone volume measured by low-dose whole body CT over twelve-months treatment during open-label extension of AZD0530 compared to the historical data of Clementia (NCT02322255) | Baseline, month 6, month 12, month 18 | |
| Secondary | Change in the volume of individual HO lesions | Baseline, month 6, month 12, month 18 | measured by low-dose whole body CT over the initial 6 month RCT and the change over twelve-months therapy during open-label extension of AZD0530 compared to the historical data of Clementia and compared to the 6 months placebo-arm. |
| Secondary | Change in number of HO lesions measured by CT over the initial 6 month RCT and in addition the change over twelve-months during open-label extension of AZD0530 compared to the historical data of Clementia and compared to the 6 months placebo-arm. | Baseline, month 6, month 12, month 18 | |
| Secondary | In patients follow-up of lesion activity | Baseline, month 6, month 12 | by 18F-NaF PET over the initial 6 month RCT and over months 6-12 compared to the 6 months RCT of the placebo arm, including change from baseline in 18F-NaF Standard Uptake Volume (SUVmean or peak) of individual active HO sites up to most active seven lesions. |
| Secondary | Follow-up of HO growth | Baseline, month 6, month 12 | Follow-up up to 7 most active HO lesion identified at CT at baseline: Change in volume from baseline to 6 for comparion in RCT en at 12 months for compariosn placebo RCT with its switch over |
| Secondary | Change and percent change from baseline in biomarkers of bone formation levels in serum over time. | Baseline, week 3 through month 18 | Including Total Procollagen Type 1 N-Terminal Propeptide (P1NP), Alkaline Phosphatase (AP) fasting cross-linked C-terminal telopeptide of type I colla-gen (βCTX). Selected genetic markers for FOP activity |
| Secondary | Joint function assessment by physician at baseline and week 3, month 3,6,9,12,and18 by the cumulative analog joint involvement scale (CAJIS) and the quantitative detailed multi-joint assessment and mounth at baseline and month 6, 12 and 18 | baseline, week 3, month 3,6,9,12,and 18 | |
| Secondary | Patient-reported global health status the 36-item Short Form Health Survey (SF-36) at baseline and week 3, month 3,6,9,12,and 18 | baseline, week 3, month 3,6,9,12,and 18 | |
| Secondary | FOP disease activity assessed by movement disabilities and quality of life using FOP Independent Activity of Daily Living (FOP I-ADL) | baseline, week 3, month 3,6,9,12,and 18 | |
| Secondary | Number of patient reported and investigator confirmed flare-ups | Each day (day 0-month18) | |
| Secondary | Pharmacokinetic measurements: blood for determination of plasma concentrations of AZD0530 (pre-dose)on the day of the study visits at 6, 12 and 18months | 6,12 and 18months |
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
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GET https://conductscience.org/api/trials/v1/NCT04307953/registered