Trial · NCT03245840
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration up to End of study (EOS) (Up to Month 53) | The safety set consisted of all participants who received at least 1 dose of BOS. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Physical Examination Findings | From start of study drug administration up to EOS (Up to Month 53) | The safety set consisted of all participants who received at least 1 dose of BOS. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | From start of study drug administration up to EOS (Up to Month 53) | The safety set consisted of all participants who received at least 1 dose of BOS. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Month 12 | Baseline, Month 12 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. DXA was performed for participants aged 11-17 years only and no participants of this age range were present in PBO-BOS group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 24 | Baseline, Month 24 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. DXA was performed for participants aged 11-17 years only and no participants of this age range were present in PBO-BOS group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 36 | Baseline, Month 36 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. DXA was performed for participants aged 11-17 years only and no participants of this age range were present in PBO-BOS group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 48 | Baseline, Month 48 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. DXA was performed for participants aged 11-17 years only and no participants of this age range were present in PBO-BOS group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at EOS (Up to Month 53) | Baseline, EOS (Up to Month 53) | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. DXA was performed for participants aged 11-17 years only and no participants of this age range were present in PBO-BOS group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Cortisol Level After Adrenocorticotropic Hormone (ACTH) Stimulation at Month 12 | Baseline, Month 12 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. | micrograms per deciliter (mcg/dL) | MEAN |
| PRIMARY | Change From Baseline in Cortisol Level After ACTH Stimulation at Month 24 | Baseline, Month 24 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. | mcg/dL | MEAN |
| PRIMARY | Change From Baseline in Cortisol Level After ACTH Stimulation at Month 36 | Baseline, Month 36 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. | mcg/dL | MEAN |
| PRIMARY | Change From Baseline in Cortisol Level After ACTH Stimulation at Month 48 | Baseline, Month 48 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. | mcg/dL | MEAN |
| PRIMARY | Change From Baseline in Cortisol Level After ACTH Stimulation at EOS (Up to Month 53) | Baseline, EOS (Up to Month 53) | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. | mcg/dL | MEAN |
| PRIMARY | Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | From start of study drug administration up to EOS (Up to Month 53) | The safety set consisted of all participants who received at least 1 dose of BOS. | Participants | COUNT_OF_PARTICIPANTS |
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.
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