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Trial · NCT07530705

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryAdverse events (safety)From the first dose through 30 days after the last dose for non-serious adverse events, and through 3 months after the last dose for severe adverse events.
Adverse events, including serious adverse events. Assessment methods: spontaneous reports; scheduled laboratory tests (hematology, chemistry, C-reactive protein, urinalysis); vital signs (blood pressure, heart rate, respiratory rate, temparature), physical examinations, and electrocardiogram (QTc interval, arrhythmia).
SecondaryPTH(1-84) (efficacy)
Single dose: Predose (within one hour before administration), and 4, 8, 12, 18, 24, 30, 36, 48, 60, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 4, 8, 12, 24, 30, 36, 48, 60, and 72 hours after the last dose.
serum PTH(1-84)
SecondaryPTH (efficacy)
Single dose: Predose (within one hour before administration), and 4, 8, 12, 18, 24, 30, 36, 48, 60, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 4, 8, 12, 24, 30, 36, 48, 60, and 72 hours after the last dose
serum PTH
SecondarySerum calcium (efficacy)
Single dose: Predose (within one hour before administration), and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Serum calcium
SecondarySerum phosphorus (efficacy)
Single dose: Predose (within one hour before administration), and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Serum phosphorus
SecondarySerum magnesium (efficacy)
Single dose: Predose (within one hour before administration), and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Serum magnesium
Secondary1, 25-Dihydroxyvitamin D3 (efficacy)Single dose: Predose (within one hour before administration); and 24, 48, and 72 hours postdose. Multiple dose: Predose on Day 1, Day 3, Day 5; and 48 hours and 72 hours after the last dose.Serum 1, 25-Dihydroxyvitamin D3
Secondary24-hour urine calcium (efficacy)Single dose: Predose (within 3 days before administration), and 24, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose), and 24, 48, and 72 hours after the last dose24-hour urine calcium (24hUCa)
SecondaryFractional Excretion of calcium (efficacy)
Single dose: Predose (within one hour before administration), and 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose), and 24, 48, and 72 hours after the last dose
Fractional Excretion of calcium (FECa)
OtherProcollagen type 1 N-terminal propeptide (Exploratory endpoint)Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last doseSerum Procollagen type 1 N-terminal propeptide (P1NP)
OtherBeta-isomerized C-terminal telopeptide of type 1 collagen (Exploratory endpoint)Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last doseSerum Beta-isomerized C-terminal telopeptide of type 1 collagen (β-CTX)

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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