Trial · NCT01674621
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 | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Baseline, 6 Months | Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine. |
| Secondary | Percent Change From Baseline in BMD of Total Hip at 6 Months | Baseline, 6 Months | Percent change in BMD as specified by DXA scans of the total hip. |
| Secondary | Percent Change From Baseline in BMD of Forearm at 6 Months | Baseline, 6 Months | Percent change in BMD as specified by DXA scans of the forearm. |
| Secondary | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | Baseline, 6 Months | |
| Secondary | Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | Baseline, 6 Months | |
| Secondary | Percent Change From Baseline in Serum Osteocalcin at 6 Months | Baseline, 6 Months | |
| Secondary | Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | Baseline, 6 Months | |
| Secondary | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | Baseline, 6 Months | |
| Secondary | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Baseline up to 6 Months | A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section. |
| 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 | Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Secondary | Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result | Baseline up to 7 Months | The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| 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 | Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9\*10\^9/liter \[L\]; Grade 4 \<1.0\*10\^9/L), platelets (Grade 3: 25.0-49.9\*10\^9/L; Grade 4: \<25.0\*10\^9/L), haemoglobin (Grade 3: 65.0-79.0 grams \[g\]/L or 4.0-4.9 mmol/L; Grade 4: \<65.0 g/L or \<4.0 millimole \[mmol\]/L), granulocytes/bands (Grade 3: 0.5-0.9\*10\^9/L; Grade 4: \<0.5\*10\^9/L), lymphocytes (Grade 3: 0.5-0.9\*10\^9/L; Grade 4: \<0.5 \*10\^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, \> 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| 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 | Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), \>1.0 g%, or \>10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0\*normal; Grade 4: \>6.0\*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units \[U\]/L\*normal, Grade 4: \>20.0 U/L\*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L\*normal; Grade 4: \>20.0 U/L\*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L\*normal; Grade 4: \>20.0 U/L\*normal), total bilirubin (Grade 3: 1.5-3.0\*normal; Grade 4: \>3.0\*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| 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 | Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%\*normal, Grade 4: \>2.00%\*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds \[sec\], Grade 4: \>3.00 secs\*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
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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