Trial · NCT01753856
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 3 Months in Mineralizing Surface (MS) /Bone Surface (BS) in the Cancellous Compartment (CC) of the Iliac Crest Bone Biopsies | Baseline, 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the CC of the iliac crest. | percentage of BS | MEDIAN |
| SECONDARY | Number of Samples With Single or Double Tetracycline Labels, SL and DL, or No Tetracycline Labels in the CC, Endocortical Compartment (EC), Intracortical Compartment (IC) and Periosteal Compartment (PC) of the Iliac Crest Bone Biopsies | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of the number of samples with specified labels in the various compartments of the iliac crest. | Samples | NUMBER |
| SECONDARY | Change From Baseline to 3 Months in MS/BS in the Endocortical Compartment (EC), Intracortical Compartment (IC), and Periosteal Compartment (PC) of the Iliac Crest Bone Biopsies | Baseline, 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the specified compartments of the iliac crest. | percentage of BS | MEDIAN |
| SECONDARY | MS/BS in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies 3 Months Post First Dose of Study Drug | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the specified compartments of the iliac crest. | percentage of BS | MEDIAN |
| SECONDARY | Percentage of Bone With Remodeling-Based and Modeling-Based Formations in the CC, EC and PC of the Iliac Crest Bone Biopsies | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the classification of TET DLs as remodeling-based or modeling-based formation in the specified compartments of the iliac crest. | percentage of the total formation unit | MEDIAN |
| SECONDARY | Percentage of Mineralizing Surface With Remodeling-Based Formation and Modeling-Based Formation in the CC, EC and PC of the Iliac Crest Bone Biopsies | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the classification of TET DLs as remodeling- or modeling-based formation in the specified compartments of the iliac crest. | percentage of the total formation unit | MEDIAN |
| SECONDARY | Percentage of Overfilled Remodeling Sites in the CC, EC and PC of the Iliac Crest Bone Biopsies | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy evaluated for overfilled remodeling sites in the specified compartments of the iliac crest. | percentage of overfilled remodeling site | MEDIAN |
| SECONDARY | Change From Baseline to 3 Months in Label Length Within Each Basic Multicellular Unit (BMU) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies | Baseline, 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with label lengths measured in the specified compartments of the iliac crest. | millimeters (mm) | MEDIAN |
| SECONDARY | Change From Baseline to 3 Months in Mineral Apposition Rate (MAR) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies | Baseline, 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an evaluation of MAR in the CC, EC, IC and PC of the iliac crest. | mcm/day | MEDIAN |
| SECONDARY | Change From Baseline to 3 Months in Bone Formation Rate/Bone Surface (BFR/BS ) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies | Baseline, 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with BFR/BS assessments in the specified compartments of the iliac crest. | mm³/mm²/year | MEDIAN |
| SECONDARY | Percentage of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS or dLS/BS) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with label surface measured in the specified compartments of the iliac crest. | percentage of TET label | MEDIAN |
| SECONDARY | Percentage Change From Baseline to 1, 3, and 6 Months in Intact Parathyroid Hormone (PTH) | Baseline, 1, 3, and 6 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had serum PTH assessed at baseline and the specified time points. | percentage change in PTH | MEDIAN |
| SECONDARY | Percentage Change From Baseline to 1, 3, and 6 Months in Serum Procollagen Type I N-terminal Propeptide (P1NP) | Baseline, 1, 3, and 6 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had serum P1NP measurements at baseline and the specified time points. | percentage change in P1NP | MEDIAN |
| SECONDARY | Percentage Change From Baseline to 1, 3, and 6 Months in Serum Osteocalcin | Baseline, 1, 3, and 6 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had serum osteocalcin measured at baseline and the specified time points. | percentage change in osteocalcin | MEDIAN |
| SECONDARY | Percentage Change From Baseline to 1, 3, and 6 Months in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) | Baseline, 1, 3, and 6 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and serum CTX measured at baseline and the specified time points. | percentage change in CTX | MEDIAN |
| SECONDARY | Activation Frequency (Ac.f) in the CC, EC and IC of the Iliac Crest | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with Ac.f assessments in the CC, EC and IC of the iliac crest. | new cycles per year | MEDIAN |
| SECONDARY | Adjusted Apposition Rate (Aj.AR) in the CC, EC and IC of the Iliac Crest | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with Aj.AR assessments in the CC, EC and IC of the iliac crest. | µm/day | MEDIAN |
| SECONDARY | Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the CC of the Iliac Crest | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of OV/BV in the CC of the iliac crest. | percentage of BV | MEDIAN |
| SECONDARY | Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the CC, EC and IC of the Iliac Crest | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the assessment of OS/BS in the CC, EC and IC of the iliac crest. | percentage of BS | MEDIAN |
| SECONDARY | Osteoid Thickness (O.Th) in the CC, EC and IC of the Iliac Crest | 3 months post first dose of study drug | Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an O.Th assessment in the CC, EC and IC of the iliac crest. | micrometers (mcm) | MEDIAN |
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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