Study ID | Endpoints |
Thacher 2014 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source:clinicaltrials.gov/ct2/show/NCT00949832 Primary outcome measure: XR healing of rickets (time frame: 6 months) Secondary outcome measures: alkaline phosphatase (time frame: 6 months), serum calcium (time frame: 6 months), 25‐hydroxy vitamin D (time frame: 6 months), 1,25‐dihydroxy vitamin D (time frame: 2 weeks), calcium absorption (time frame: 1 week) Other outcome measures: — Trial results available in trial register: no | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measure: combined attainment of a radiographic score of ≤ 1.5 and a serum alkaline phosphatase concentration of ≤ 350 U/L Secondary outcome measure: — Other outcome measures: 25‐hydroxy vitamin D, serum calcium | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measures: main outcome measure achievement of a 10‐point radiographic severity score ≤ 1.5 and serum alkaline phosphatase ≤ 350 U/L Secondary outcome measures: — Other outcome measure: 25‐hydroxy vitamin D | |
Aggarwal 2013 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: CTRI/2010/091/000448 (www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=1634&EncHid=&modid=&compid=%27,%271634det%27) Primary outcome measures: percentage of participants showing complete radiological and biochemical evidence of healing of rickets Secondary outcome measures: — Other outcome measures: — Trial results available in trial register: no | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measures: improvement in radiological score and biochemical parameters of healing of rickets at 12 weeks Secondary outcome measures: — Other outcome measure: adverse events | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measures: — Secondary outcome measures: — Other outcome measures: mean serum 25‐hydroxycholecalciferol D levels, radiological and biochemical evidence of healing rickets, combined endpoint of normal serum alkaline phosphatase and complete radiological healing at 12 weeks | |
Balasubramanian 2003 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measures: — Secondary outcome measures: — Other outcome measure: healing of rickets | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measures: — Secondary outcome measures: — Other outcome measures: healing of rickets, 25 hydroxy vitamin D | |
Thacher 1999 | Endpoints quoted in trial document(s) (ClinicalTrials.gov, FDA/EMA document, manufacturer's website, published design paper)a,c |
Source: NT | |
Endpoints quoted in publication(s)b,c | |
Primary outcome measures: changes in serum calcium and alkaline phosphatase concentrations and radiographic scores Secondary outcome measures: — Other outcome measures: fractures, height, height‐for‐age, weight, serum albumin, serum phosphorus, serum 1,25‐dihydroxy vitamin D concentrations; % of children with the combined outcome of a serum alkaline phosphatase concentration ≤ 350 U/L and radiographic score ≤ 1.5 (indicating nearly complete resolution of the abnormalities) after 24 weeks of treatment) | |
Endpoints quoted in abstract of publication(s)b,c | |
Primary outcome measures: — Secondary outcome measures: — Other outcome measures: serum calcium concentration, combined endpoint of a serum alkaline phosphatase concentration ≤ 350 U/L and radiographic evidence of nearly complete healing of rickets | |
—: denotes not reported.
aTrial document(s) refers to all available information from published design papers and sources other than regular publications (e.g. FDA/EMA documents, manufacturer's websites, trial registers).
bPublication(s) refers to trial information published in scientific journals (primary reference, duplicate publications, companion documents or multiple reports of a primary study).
cPrimary and secondary outcomes refer to verbatim specifications in publication/records. Unspecified outcome measures refer to all outcomes not described as primary or secondary outcome measures. EMA: European Medicines Agency; FDA: Food and Drug Administration (US); NT: no trial document available. |