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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Calcitonin for Treating X-linked Hypophosphatemia

NCTNCT01652573 (opens ClinicalTrials.gov in a new tab)Other id1010007548Other idR21AR061818
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
21 participants (actual)
Sponsor
Yale University · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Mar 2011
Primary completion
Sept 2015
Completion
Sept 2015
First posted
30 Jul 2012 (estimated)
Last update posted
31 May 2017
Conditions
Hypophosphatemic Rickets, X Linked Dominant

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013201420152016
  1. N/A

    Calcitonin for Treating X-linked Hypophosphatemia

    NCT01652573

    Mar 2011 to Sept 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United States. It also causes bone disease in adults. XLH is caused by overproduction of a hormone call FGF23, which makes the body waste phosphate. This study is designed to determine if nasal calcitonin, an already approved drug in the US, can lower blood levels of FGF23 and reduce phosphate wasting in patients with XLH. In this study the investigators will: 1. Determine whether nasal calcitonin significantly lowers integrated 24-hour blood levels of FGF23 in patients with XLH. 2. Evaluate whether nasal calcitonin improves serum phosphate levels in XLH. 3. Assess whether nasal calcitonin improves blood levels of the active form of vitamin D and calcium absorption from the intestine. 4. Make sure that nasal calcitonin is safe and well tolerated.

Interventions

  • nasal salmon calcitoninDrug
  • Saline Nasal Spray PlaceboDrug

Arms2

  • Experimental

    Nasal calictonin

    Subjects will received nasal calcitonin once daily

  • Placebo comparator

    Saline Nasal spray

    Patients will receive saline nasal spray once daily

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Area Under the Curve for FGF23

    Time frame · Time 0

    Registry description

    FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission and AUC calculated.

  2. Area Under the Curve for FGF23

    Time frame · 3 months

    Registry description

    FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission at 3 months and AUC calculated and compared to baseline.

Secondary outcomes(16)

  1. Area Under the Curve for TmP/GFR

    Time frame · Time 0

    Registry description

    Serum phosphate will be measured 0 to 24 hours postdose during a 24 hr admission, AUC calculated, and fasting Tmp/GFR calculated.

  2. Area Under the Curve for 1,25(OH)2vitamin D

    Time frame · Time 0

    Registry description

    Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated.

  3. Number of Patients With Nasal Congestion at Baseline

    Time frame · Time 0

    Registry description

    This symptom will be assessed at baseline

  4. Area Under the Curve for TmP/GFR

    Time frame · Time 3 months

    Registry description

    TmP/GFR will be measured 0 to 24 hours postdose during a 24 hr admission at 3 months and AUC calculated and compared to baseline.

  5. Area Under the Curve for 1,25(OH)2vitamin D

    Time frame · Time 3 months

    Registry description

    Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated and results will be compared to baseline values.

  6. Number of Participants With Nasal Congestion at 1 Month

    Time frame · Time 1 month

    Registry description

    This symptom will be assessed.

  7. Number of Participants With Nasal Congestion at 2 Months

    Time frame · Time 2 months

    Registry description

    This symptom will be assessed.

  8. Number of Participants With Nasal Congestion at 3 Months

    Time frame · Time 3 months

    Registry description

    This symptom will be assessed.

  9. Number of Participants With Nasal Ulcerations at Baseline

    Time frame · Time 0

    Registry description

    This symptom will be assessed at baseline

  10. Number of Participants With Allergic Reactions at Baseline

    Time frame · Time 0

    Registry description

    This symptom will be assessed at baseline

  11. Number of Participants With Nasal Ulceration at 1 Month

    Time frame · Time 1 month

    Registry description

    This symptom will be assessed.

  12. Number of Participants With Allergic Reactions at 1 Month

    Time frame · Time 1 month

    Registry description

    This symptom will be assessed.

  13. Number of Participants With Nasal Ulceration at 2 Months

    Time frame · Time 2 months

    Registry description

    This symptom will be assessed.

  14. Number of Participants With Allergic Reactions at 2 Months

    Time frame · Time 2 months

    Registry description

    This symptom will be assessed.

  15. Number of Participants With Nasal Ulcerations at 3 Months

    Time frame · Time 3 months

    Registry description

    This symptom will be assessed.

  16. Number of Participants With Allergic Reactions at 3 Months

    Time frame · Time 3 months

    Registry description

    This symptom will be assessed.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Time 0

Area Under the Curve for FGF23

GroupValue (pg/ml*hr)
Nasal Calictonin3172.34
Saline Nasal Spray3215.34
Primary outcomeLeast squares mean· 3 months

Area Under the Curve for FGF23

GroupValue (pg/ml*hr)
Nasal Calictonin2698.38
Saline Nasal Spray2994.26
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· Time 0

Area Under the Curve for TmP/GFR

GroupValue (mg/100 ml GF*hr)
Nasal Calictonin30.70
Saline Nasal Spray29.97
Secondary outcomeLeast squares mean· Time 0

Area Under the Curve for 1,25(OH)2vitamin D

GroupValue (ng/ml*hr)
Nasal Calictonin904.06
Saline Nasal Spray838.58
Secondary outcomeCount of participants· Time 0

Number of Patients With Nasal Congestion at Baseline

GroupValue (Participants)
Nasal Calictonin0
Saline Nasal Spray0
Secondary outcomeLeast squares mean· Time 3 months

Area Under the Curve for TmP/GFR

GroupValue (mg/100 ml GF*hr)
Nasal Calictonin32.17
Saline Nasal Spray31.26
Secondary outcomeLeast squares mean· Time 3 months

Area Under the Curve for 1,25(OH)2vitamin D

GroupValue (ng/ml*hr)
Nasal Calictonin1277.05
Saline Nasal Spray1258.84
Secondary outcomeCount of participants· Time 1 month

Number of Participants With Nasal Congestion at 1 Month

GroupValue (Participants)
Nasal Calictonin3
Saline Nasal Spray2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Nasal CalictoninSubjects will received nasal calcitonin once daily nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)0 / 100 / 102 / 10
Saline Nasal SprayPatients will receive saline nasal spray once daily Saline Nasal Spray Placebo0 / 110 / 112 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * age ≥18 or greater * an established diagnosis of XLH * fasting serum calcium ≤10.5 mg/dl * fasting PTH at time of screen \</= 1.7 times the upper limit of normal Exclusion Criteria: * estimated creatinine clearance \< 60 cc/min and/or serum creatinine \> 1.5 mg/dl; * serum 25(OH)vitamin D \< 30 ng/ml. Potential study subjects who have a serum 25(OH)vitamin D \< 30 ng/ml will be supplemented with 25(OH)vitamin D to achieve a serum value \> 30 ng/ml and then re- screened * inability to comply with instructions and appropriate follow up visits * treatment with agents that may skeletal metabolism such as glucocorticoids, bisphosphonates, denosumab, teriparatide, estrogen and anticonvulsants.

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