Trial · NCT01674621
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 | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in BMD of Total Hip at 6 Months | Baseline, 6 Months | mITT population included all participants with pre-treatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in BMD of Forearm at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Osteocalcin at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Baseline up to 6 Months | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Baseline up to 7 Months | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result | Baseline up to 7 Months | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4 | Baseline up to 6 Months | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | Baseline up to 6 Months | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4 | Baseline up to 6 Months | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01674621/outcomes