Clinical Trials Logo

Clinical Trial Summary

X-linked hypophosphatemia (XLH) is a rare genetic skeletal disease where increased phosphate wasting in the kidney leads to hypophosphatemia and prevents normal mineralization of bone and dentin, with osteomalacia as a principal manifestation. In previous works, the investigators have shown that adults with XLH present with more frequent and severe periodontitis than in the general population, and that vitamin D and phosphate supplementation improves their periodontal health, as it does for the osteomalacia. Their medical records also reveal that early implant failure is dramatically increased in these patients, when no supplementation is implemented, and standard surgical protocols followed. In contrast, the investigator's preliminary data showed that successful osseointegration was achieved with supplementation prior and after implant placement and extended healing time. Here, the investigators propose to assess the current recommendations for implant therapy in XLH patients, with 24 implants placed. The current recommendations consist of: 1) supplementation with vitamin D and phosphate for 3 months prior to implant placement and 6 months after; 2) implant healing time extended to 6 months. If osseointegration is achieved, prosthesis will be fabricated. Radiographic and clinical examination at 6, 12, 18 and 24 months after placement of the definitive restoration will evaluate the implant osseointegration, crestal bone level and peri-implant tissues health.


Clinical Trial Description

Primary objective: to evaluate the efficacy of the specific implant management currently offered to XLH patients according to the recommendations, in terms of implant survival. Secondary objectives: 1. to study the evolution of the peri-implant bone level within 2 years after implant placement ; 2. to study the evolution of the stability of the peri-implant tissues in the 2 years following the installation of the implant ; 3. to describe the osseointegration of the implant 6 months after insertion ; 4. to evaluate the effectiveness of the specific implant management in terms of the delay in occurrence of the first implant loss of patients ; 5. to describe the reasons for removal of the implants ; 6. to evaluate the satisfaction of the implant treated patient ; 7. to describe the occurrence of dental plaque, suppuration or bleeding around implants. Experimental plan: this is an observational prospective study with historical control group (retrospective compendium) comparing XLH-specific implant management (prior phosphorus / vitamin D supplementation and prolonged implant healing) to non-specific management. For prospective inclusion (patients with specific implant management) patients will be recruited from adults with XLH as part of an oral assessment. After inclusion each patient will be followed 24 months. The surgical treatment and the clinical and radiographic follow-up correspond to the specific management proposed in our service to the patients presenting an XLH. Prior to implant placement, a cone-beam computed tomography scan will confirm adequate bone volume for implant placement. Implant surgery will be performed under local anesthesia following the protocols recommended by the manufacturer. The follow-up is done during the healing period and the realization of the implant prosthesis (6 months after surgery) then 12, 18 and 24 months after the surgery. It will include a clinical and radiographic examination, and will verify the presence of the implant in the mouth (survival of the implant), and the stability of the peri-implant tissues (level of attachment and bone level) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03879915
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact Martin Biosse Duplan, DDS, PhD
Phone +33 1 53 11 14 15
Email martin.biosse-duplan@aphp.fr
Status Recruiting
Phase
Start date September 27, 2019
Completion date December 31, 2022

See also
  Status Clinical Trial Phase
Completed NCT02915705 - Efficacy and Safety of Burosumab (KRN23) Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With X Linked Hypophosphatemia (XLH) Phase 3
Active, not recruiting NCT03193476 - Registry for Patients With X-Linked Hypophosphatemia
Completed NCT02526160 - Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH) Phase 3
Recruiting NCT05181839 - A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth
Completed NCT04146935 - Examining the Effect of Burosumab on Muscle Function Phase 4
Completed NCT02750618 - Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH) Phase 2
Active, not recruiting NCT03745521 - Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners
Completed NCT03920072 - Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH Phase 3
Recruiting NCT03748966 - Calcitriol Monotherapy for X-Linked Hypophosphatemia Early Phase 1
Recruiting NCT04419363 - Burosumab in Children and Adolescents With X-linked Hypophosphatemia Phase 4
Completed NCT02163577 - Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH) Phase 2
Active, not recruiting NCT03651505 - X-linked Hypophosphatemia Disease Monitoring Program
Completed NCT06067932 - Foot Disorders in X-linked Hypophosphatemia
Completed NCT04695860 - Anti-FGF23 (Burosumab) in Adult Patients With XLH Phase 3
Completed NCT02312687 - Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH) Phase 2
Completed NCT03596554 - X-linked Hypophosphatemia and FGF21
Recruiting NCT03820518 - Using Different Doses of Active Vitamin D Combined With Neutral Phosphate in Children With X-linked Hypophosphatemia Phase 4
Completed NCT01571596 - An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia Phase 1/Phase 2
Completed NCT04273490 - Characterising Pain, QoL, Body Composition, Arterial Stiffness, Muscles and Bones in Adult Persons With XLH and Healthy Controls
Completed NCT03489993 - FGF23 and Angiotensin-(1-7) in Hypophosphatemia (GAP)