N/A
N=21
Calcitonin for Treating X-linked Hypophosphatemia
Hypophosphatemic Rickets, X Linked Dominant
Bottom Line
View on ClinicalTrials.gov: NCT01652573 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Area Under the Curve for FGF23 — 3172.34; 3215.34 pg/ml*hr
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nasal salmon calcitonin (Drug); Saline Nasal Spray Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve for FGF23 |
2698.38; 2994.26 | — |
| PRIMARY Area Under the Curve for FGF23 |
2698.38; 2994.26 | — |
| SECONDARY Area Under the Curve for TmP/GFR |
32.17; 31.26 | — |
| SECONDARY Area Under the Curve for 1,25(OH)2vitamin D |
1277.05; 1258.84 | — |
| SECONDARY Number of Patients With Nasal Congestion at Baseline |
0; 0 | — |
| SECONDARY Area Under the Curve for TmP/GFR |
32.17; 31.26 | — |
| SECONDARY Area Under the Curve for 1,25(OH)2vitamin D |
1277.05; 1258.84 | — |
| SECONDARY Number of Participants With Nasal Congestion at 1 Month |
3; 2 | — |
| SECONDARY Number of Participants With Nasal Congestion at 2 Months |
1; 0 | — |
| SECONDARY Number of Participants With Nasal Congestion at 3 Months |
0; 0 | — |
| SECONDARY Number of Participants With Nasal Ulcerations at Baseline |
0; 0 | — |
| SECONDARY Number of Participants With Allergic Reactions at Baseline |
0; 0 | — |
| SECONDARY Number of Participants With Nasal Ulceration at 1 Month |
0; 2 | — |
| SECONDARY Number of Participants With Allergic Reactions at 1 Month |
0; 0 | — |
| SECONDARY Number of Participants With Nasal Ulceration at 2 Months |
0; 0 | — |
| SECONDARY Number of Participants With Allergic Reactions at 2 Months |
0; 0 | — |
| SECONDARY Number of Participants With Nasal Ulcerations at 3 Months |
0; 1 | — |
| SECONDARY Number of Participants With Allergic Reactions at 3 Months |
0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- age ≥18 or greater
- an established diagnosis of XLH
- fasting serum calcium ≤10.5 mg/dl
- fasting PTH at time of screen 1.5 mg/dl;
- serum 25(OH)vitamin D 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.
Data sourced from ClinicalTrials.gov (NCT01652573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.