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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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18 August 2020 |
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Main ID: |
EUCTR2011-002811-27-DK |
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Date of registration:
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04/11/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta
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Scientific title:
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The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta - OI-treatment |
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Date of first enrolment:
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07/11/2011 |
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Target sample size:
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80 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002811-27 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Osteoporoseklinikken
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Address:
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Tage Hansensgade 2, 11B
8000
Aarhus
Denmark |
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Telephone:
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004589497681 |
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Email:
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Affiliation:
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Aarhus University Hospital |
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Name:
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Osteoporoseklinikken
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Address:
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Tage Hansensgade 2, 11B
8000
Aarhus
Denmark |
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Telephone:
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004589497681 |
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Email:
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Affiliation:
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Aarhus University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Inklusion criterias
• Patients with OI type I and IV
• Age 22 - 70 years
• Informed consent
o Low BMD (T-score =/< -1.0) or =/<-1
• For women: = 1 year postmenopausal
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Exklusion criterias
• Creatinine clearance < 30 mL/min
• Previous treatment with PTH. Previous treatment with antiresorptives is not an exclusion criteria, but will be used for stratification of the patients
• Treatment with glucocorticoids = 5mg daily during the last 3 months.
• Metabolic bone disease or vitamin D deficiency.
• Liver- or kidney disease
• Existing contra indications for treatment with zoledronic acid or PTH
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Osteogenesis imperfecta
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Intervention(s)
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Trade Name: Forsteo
Product Code: H05AA02
Pharmaceutical Form: Solution for injection in pre-filled pen
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administration of the placebo: Subcutaneous use
Trade Name: Aclasta
Pharmaceutical Form: Infusion
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Main Objective: A descriptive investigation of adult Danish patients with OI is at the moment being conducted. In this study the underlying genetic background is compared with the phenotype.
The aim of the present study is to investigate the effect of treatment of adult patients with OI with bisphosphonate (zoledronic acid)and parathyroid hormone (PTH) compared with placebo on bone mass, fracture risk and quality of life. The hypothesis is tested in a randomized, placebo controlled, double blind trial.
The following endpoints have been identified:
Primary endpoint:
1. The effect of the treatments on bone mineral density (BMD) at the lumbar spine.
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Timepoint(s) of evaluation of this end point: DXA evaluation at 6, 12, 18, 24, 30 and 36 months
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Primary end point(s): Primary endpoint:
1. The effect of the treatments on bone mineral density (BMD) at the lumbar spine.
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Secondary Objective: Secondary endpoints:
1. The effect of the treatments on bone mineral density (BMD) at the hip (femoral neck and total hip)
2. The effect of the treatments on fracture risk
3. The effect of the treatments on bone turnover evaluated by biochemical markers before, during and after treatment.
4. The effect of the treatments on bone architecture evaluated by histomorphometry after 2 years treatment.
5. The effect of the treatments on bone architecture investigated by QCT and pQCT before and after 2 years treatment.
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Secondary Outcome(s)
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Secondary end point(s): Secondary endpoints:
1. The effect of the treatments on bone mineral density (BMD) at the hip (femoral neck and total hip)
2. The effect of the treatments on fracture risk
3. The effect of the treatments on bone turnover evaluated by biochemical markers before, during and after treatment.
4. The effect of the treatments on bone architecture evaluated by histomorphometry after 1 years treatment.
5. The effect of the treatments on bone architecture investigated by QCT and pQCT before, after 1 year of treatment and after treatment.
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Timepoint(s) of evaluation of this end point: ad 1: DXA evaluation at 6, 12, 18, 24, 30 and 36 months
ad 2: Continuously and at 36 months
ad 3: before, during (at 1, 3, 6, 12, 18, 24 and 30 months) and after treatment.
ad 4: after year 1
ad 5: before treatment, after 1 year of treatment and after treatment.
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Source(s) of Monetary Support
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Pharma-Vinci
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Eli Lilly
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Ethics review
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Status: Approved
Approval date: 22/06/2011
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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