ZOMETA: Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT03301285
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 20.5

Study Details

Study Description

Brief Summary

The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone density in children with osteoporosis caused by multiple disabilities.

Secondary purposes are:

1. Description of child population with osteoporosis in the context of motor impairment in Lorraine region

2. Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities

3. Description of current osteoporosis preventive care

4. Description of risk factors associated to bone status (drugs)

5. Evaluation of zoledronic acid treatment on fracture numbers

6. Evaluation of zoledronic acid on phosphocalcic profile

7. Description of side effects of zoledronic acid in this indication

8. Description of treatment effects in the sub-population of children with Rett syndrome.

Condition or Disease	Intervention/Treatment	Phase
Multiple Disability; Osteoporosis	Drug: Zoledronic Acid

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Crossover
• Time Perspective: Retrospective
• Official Title: Study of Efficacy of Zoledronic Acid in the Management of Osteoporosis in Children With Multiple Disabilities
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Mar 31, 2017
• Actual Study Completion Date: Mar 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Children with osteoporosis associated to multiple disabilities Treated with zoledronic acid	Drug: Zoledronic Acid; Treatment of osteoporosis

Outcome Measures

Primary Outcome Measures

1. Change from baseline (before start of zoledronic acid treatment) lumbar bone density [through study completion, 4 years]

   reported in Z-score

Secondary Outcome Measures

1. Age [Baseline]

2. Sex [Baseline]

3. Height [Baseline]

4. Weight [Baseline]

5. Occurrence of bone fractures [Until baseline]

6. Long-term administration of vitamin/calcium supplement or not [baseline]

7. Administration of drugs or not [baseline]

8. Number of fractures after the start of zoledronic acid treatment [through study completion, 4 years]

9. Change from baseline phosphocalcic profile evaluation [through study completion, 4 years]

10. Frequency of side effects [through study completion, 4 years]

11. Change from baseline lumbar bone density in sub-population of children with Rett syndrome after 1 year of zoledronic acid treatment [1 year from baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Non refusal of parents of participation of their child to the study

• Patients followed for multiple disabilities

• Osteoporosis: lumbar osteodensitometry z-score <-2.5 SD associated or not to pathologic fracture

Exclusion Criteria:

• Bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta)

• Absence of multiple disabilities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital - CHRU de Nancy	Vandoeuvre les nancy		France

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT03301285
• Other Study ID Numbers: PSS2016/ZOMETA-FEILLET/VS
• First Posted: Oct 4, 2017
• Last Update Posted: Oct 4, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoporosis; Zoledronic Acid

Study Results

No Results Posted as of Oct 4, 2017