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Trial · NCT03324880

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryChange From Baseline in Serum Phosphate Level at Week 26Baseline, Week 26Change in serum phosphate level at Week 26 was reported. A MMRM was used for analysis.
SecondaryChange From Baseline in Doses of Active Vitamin D at Week 26Baseline, Week 26Changes in doses of active vitamin D at Week 26 was reported. A MMRM was used for analysis.
SecondaryChange From Baseline in Doses of Calcium Supplements at Week 26Baseline, Week 26Changes in doses of calcium supplements at Week 26 was reported. A MMRM was used for analysis.
SecondaryChange From Baseline in Albumin-corrected Serum Calcium Control at Week 26Week 26
Change From Baseline in albumin-corrected serum calcium between 1.875 millimoles per liter (mmol/L) (7.5 milligram per deciliter \[mg/dL\]) and upper limit of normal (ULN) for the central laboratory normal range at Week 26 was reported.
SecondaryNumber of Participants Who Achieve Composite Criteria for Albumin-corrected Serum Calcium Concentration, Active Vitamin D Dose and Oral Elemental Calcium Supplement Dose at Week 26Week 26
Number of participants achieving composite criteria of the following: albumin-corrected serum calcium between 1.875 mmol/L (7.5 mg/dL) and the ULN for the central laboratory normal range, dose of active vitamin D decreased by 50% and at least a 50% reduction from the baseline oral elemental calcium supplement dose at Week 26 was reported.
SecondaryChange From Baseline in Bone Turnover Marker Bone Specific Alkaline Phosphatase at Week 26Baseline, Week 26Bone turnover markers included serum bone-specific alkaline phosphatase, procollagen amino-terminal peptide, C-terminal telopeptide of type 1 collagen, and osteocalcin. A MMRM was used for analysis.
SecondaryChange From Baseline in Bone Turnover Marker Type I Collagen C-Telopeptides at Week 26Baseline, Week 26Bone turnover markers included serum bone-specific alkaline phosphatase, procollagen amino-terminal peptide, C-terminal telopeptide of type 1 collagen, and osteocalcin. A MMRM was used for analysis.
SecondaryChange From Baseline in Bone Turnover Marker Osteocalcin and Procollagen 1 N-Terminal Propeptide at Week 26Baseline, Week 26Bone turnover markers included serum bone-specific alkaline phosphatase, procollagen amino-terminal peptide, C-terminal telopeptide of type 1 collagen, and osteocalcin. A MMRM was used for analysis.
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)From start of study drug administration to 4 weeks post follow-up (up to Week 36)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as AEs that started or worsened on or after the date and time of the first dose of investigational product.

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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