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Trial · NCT05328154

Registered outcomes60

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

ListOutcomeTime frameDescription
PrimaryC-terminal telopeptides of collagen type 1 (CTX) dosageVisit 0: Day 0-1 monthEvaluation of the CTX evolution after one year, defined as the difference \[after - before\], relative to the basal value (ng/ml). For this purpose, a blood sample will be taken using 5 mL dry tubes.
PrimaryC-terminal telopeptides of collagen type 1 (CTX) dosageVisit 3: Day 0+1 yearEvaluation of the CTX evolution after one year, defined as the difference \[after - before\], relative to the basal value (ng/ml). For this purpose, a blood sample will be taken using 5 mL dry tubes.
SecondaryN-terminal propeptide of procollagen type 1 (P1NP) dosageVisit 1: Day 0The dosage of N-terminal propeptide of procollagen type 1 (P1NP) (µg/l) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes.
SecondaryN-terminal propeptide of procollagen type 1 (P1NP) dosageVisit 3: Day 0+1 yearThe dosage of N-terminal propeptide of procollagen type 1 (P1NP) (µg/l) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes.
SecondaryOsteocalcin dosageVisit 1: Day 0The dosage of osteocalcin (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes
SecondaryOsteocalcin dosageVisit 3: Day 0+1 yearThe dosage of osteocalcin (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes
SecondarySclerostin dosageVisit 1: Day 0The dosage of slerostin (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes.
SecondarySclerostin dosageVisit 3: Day 0+1 yearThe dosage of slerostin (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes.
SecondaryPeriostin dosageVisit 1: Day 0The dosage of periostin (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes.
SecondaryPeriostin dosageVisit 3: Day 0+1 yearThe dosage of periostin (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes.
SecondaryIrisin dosageVisit 1: Day 0The dosage of irisin (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken on 4 mL heparin tube for irisin dosage.
SecondaryIrisin dosageVisit 3: Day 0+1 yearThe dosage of irisin (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken on 4 mL heparin tube for irisin dosage.
SecondaryDickkopf-related protein 1 (DKK1) dosageVisit 1: Day 0The dosage of Dickkopf-related protein 1 (DKK1) (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes.
SecondaryDickkopf-related protein 1 (DKK1) dosageVisit 3: Day 0+1 yearThe dosage of Dickkopf-related protein 1 (DKK1) (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes.
SecondaryMagnesium (Mg) dosageVisit 1: Day 0A blood sample will be taken using 3 mL lithium heparin tube for the dosage of the magnesium (mmol/L).
SecondaryMagnesium (Mg) dosageVisit 2: Day 0+9 monthsA blood sample will be taken using 3 mL lithium heparin tube for the dosage of the magnesium (mmol/L).
SecondaryMagnesium (Mg) dosageVisit 3: Day 0+1 yearA blood sample will be taken using 3 mL lithium heparin tube for the dosage of the magnesium (mmol/L).
SecondaryEvaluation of bone densitometric parameters (femoral neck)Visit 0: Day 0-1 monthDensitometry analysis on the three usual sites (femoral neck) by Dual X-ray Absorptiometry (DXA). T-scores will be analyzed at these sites, as well as densitometry in grams per square centimeter.
SecondaryEvaluation of bone densitometric parameters (femoral neck)Visit 3: Day 0+1 yearDensitometry analysis on the three usual sites (femoral neck) by Dual X-ray Absorptiometry (DXA). T-scores will be analyzed at these sites, as well as densitometry in grams per square centimeter.
SecondaryEvaluation of bone densitometric parameters (total femur)Visit 0: Day 0-1 monthDensitometry analysis on the three usual sites (total femur) by Dual X-ray Absorptiometry (DXA). T-scores will be analyzed at these sites, as well as densitometry in grams per square centimeter.

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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