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Trial · NCT03027557

Outcomes35

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Lumbar Spine Bone Mineral DensityBaseline,one yearOne participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.g/cm^2MEAN
PRIMARYChange in Total Hip Bone Mineral DensityBaseline,one year
One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.
g/cm^2MEAN
PRIMARYChange in Femoral Neck Bone Mineral DensityBaseline,one year
One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.
g/cm^2MEAN
PRIMARYChange in 1/3 Forearm Bone Mineral DensityBaseline,one year
One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group did not provide results for this analysis as he/she experienced a wrist fracture prior to the final scan.
g/cm^2MEAN
PRIMARYPercentage Change in Lumbar Spine Bone Mineral DensityBaseline,one yearOne participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.% changeMEAN
PRIMARYPercentage Change in Total Hip Bone Mineral DensityBaseline,one year
One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.
% changeMEAN
PRIMARYPercentage Change in Femoral Neck Bone Mineral DensityBaseline,one year
One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.
% changeMEAN
PRIMARYPercentage Change in 1/3 Forearm Bone Mineral DensityBaseline,one year
One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group did not provide results for this analysis as he/she experienced a wrist fracture prior to the final scan.
% changeMEAN
SECONDARYChange in Volumetric BMD for the Lumbar Spine.Baseline, one year
One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. Another scan could not be included due to a technical problems with the image analysis.
mg/cm^3MEAN
SECONDARYMean P-calcium During Treatment.Monthly up to one year.mmol/lMEAN
SECONDARYPercent Change From Baseline in P-carboxy-terminal Collagen Crosslinks (CTX)Change from baseline at 48 weeks reported.One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.% changeMEDIAN
SECONDARYMedian Agatstons Score FinalBaseline, one yearSome participant from the combined and placebo groups could not be included in the analysis because they had coronary stents.score on a scaleMEDIAN
SECONDARYPatients With Nephrolithiasis Final Scan.Patients with nephrolithiasis at one year reported.One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPatients With Pancreas-calcifications Final Scan.Patients with pancreas-calcifications at one year reported.One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYReset of the Calcium Sensing Receptor?2 weeks after termination of medication.
SECONDARYVertebral Fracture Assessment - Final ScanPatients with vertebral fractures at one year reported.One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange MDI-scoreBaseline, 6 mths, one year.One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final collection of MDI-questionnaires.MDI-scoreMEDIAN
SECONDARYAdverse Reactions.Monthly up to one year.
SECONDARYBone Mineral ContentBaseline, one yearData were not collected
SECONDARYChange in Cortical Width.Baseline, one year.
One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group experienced a wrist fracture prior to the final scan and was excluded. 4 patients did not provide data for the analysis due to errors in the technique of the obtained images.
mmMEAN

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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