Registered outcomes26

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

1 to 20 of 26

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in OV/BV at Week 48	Baseline, 48 weeks	OV/BV: percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).
Secondary	Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the Lower Limit of Normal (LLN) at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24	Baseline, up to 24 weeks	The LLN was defined as 2.5 mg/dL (0.81 mmol/L). The 95% confidence interval (CI) was calculated using Wilson score method.
Secondary	Percent Change From Baseline in O.Th at Week 48	Baseline, 48 weeks	O.Th: mean thickness, given in micrometers, for osteoid seams.
Secondary	Percent Change From Baseline in OS/BS at Week 48	Baseline, 48 weeks	OS/Bs: percent of bone surface covered in osteoid.
Secondary	Percent Change From Baseline in MLt at Week 48	Baseline, 48 weeks	MLt: average time interval between osteoid formation and its subsequent mineralization; calculated by dividing the osteoid thickness by the adjusted apposition rate (O.Th/Aj.AR). Aj.AR; amount of new bone created (bone formation rate over the entire osteoid surface). Based on imputed MLt values.
Secondary	Change From Baseline in MAR at Week 48	Baseline, 48 weeks	MAR: linear rate of new bone deposition; mean distance between the double labels, divided by the time interval between them.
Secondary	Change From Baseline in MS/BS at Week 48	Baseline, 48 weeks	MS/BS: percent of bone surface that displays a tetracycline label reflecting active mineralization; calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface (\[dLS + sLS/2\]/BS). It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling.
Secondary	Change From Baseline in BFR/BS at Week 48	Baseline, 48 weeks	BFR/BS: amount of new bone formed in unit time per unit of bone surface; calculated by multiplying MS/BS by the MAR. MS/BS: percent of bone surface that displays a tetracycline label reflecting active mineralization; calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface (\[dLS + sLS/2\]/BS). It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling. MAR: linear rate of new bone deposition; mean distance between the double labels, divided by the time interval between them.
Secondary	Change From Baseline in BFR/OS at Week 48	Baseline, 48 weeks	BFR/OS: bone formation rate to osteoid surface ratio, related to the Aj.AR (amount of new bone created \[bone formation rate over the entire osteoid surface\]).
Secondary	Change From Baseline in BFR/BV at Week 48	Baseline, 48 weeks	BFR/BV: equivalent to bone turnover rate.
Secondary	Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the LLN at the End of the Dosing Cycle Between Baseline and Week 24	Baseline, up to 24 weeks	The LLN was defined as 2.5 mg/dL (0.81 mmol/L). The 95% CI was calculated using Wilson score method.
Secondary	Mean Change of Serum Phosphorus Levels at the Mid-Point of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24	Baseline, up to 24 weeks
Secondary	Percent Change of Serum Phosphorus Levels at the Mid-Point of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24	Baseline, up to 24 weeks
Secondary	Mean Change of Serum Phosphorus Levels at the End of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24	Baseline, up to 24 weeks
Secondary	Percentage Change of Serum Phosphorus Levels at the End of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24	Baseline, up to 24 weeks
Secondary	Time-Adjusted Area Under the Curve (AUC) of Serum Phosphorus Between Baseline and Week 24	Baseline, up to 24 weeks
Secondary	Change From Baseline Over Time in Serum 1,25(OH)2D	Baseline, Week 1, Week 2, Week 4, Week 20, Week 21, Week 22, Week 24, Week 48, Week 60, Week 70, Week 72, Week 84, Week 94, Week 96, Week 108, Week 120, Week 132
Secondary	Change From Baseline Over Time in 24-Hour Urinary Phosphorus	Baseline, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96, End of Study II (EOSII) (up to Week 141)
Secondary	Change From Baseline Over Time in TmP/GFR	Baseline, Week 2, Week 4, Week 12, Week 22, Week 24, Week 48, Week 60, Week 72, Week 84, Week 96, EOSII (up to Week 141)	TmP/GFR: ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate.
Secondary	Change From Baseline Over Time in TRP	Baseline, Week 2, Week 4, Week 12, Week 22, Week 24, Week 48, Week 60, Week 72, Week 84, Week 96, EOSII (up to Week 141)	TRP: tubular reabsorption of phosphate.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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Registered outcomes26

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